Dyne Therapeutics is hiring a Remote Senior Director Clinical Operations Program Lead
\nRole Summary:\n\nThe Clinical Operations (Program) Lead is the clinical operations functional representative for the Program Team, is responsible for developing and leading the strategy, planning, oversight, implementation and delivery of program and study level clinical operations deliverables as outlined in the clinical development plan (CDP). \n\nThis individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to the integrated development plan (IDP) and other key plans, such as the CDP, necessary to advance Dyne’s clinical programs. This individual develops and oversees implementation of program clinical operational strategy, ensuring appropriate considerations that include but are not limited to technical, vendor, quality site/ Investigator, geographical and patient centric considerations for the Program’s lifecycle. This individual may be responsible for one highly complex or multiple medium complexity clinical programs. This individual may have one or more direct reports. \n\nThis role is expected to require up to 20% travel, including international travel. \n\nThis role is based in Waltham, MA without the possibility of being remote.\nPrimary Responsibilities Include:\n\n\n* Leads the development and ongoing refinement of Program level study timelines and scenarios in order to contribute to the CDP, IDP and other high-level strategic plans \n\n* Provide rigorous, objective information (operational status and updates) to the Program team and, as necessary, Dyne senior leadership to help support strategic project decisions. \n\n* Takes overall accountability for operational delivery of the clinical studies within a Program and provide appropriate oversight to ensure a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals.\n\n* Actively participates in Program team and other applicable sub-team meetings, collaborating and integrating with other functions within research and development, medical, and commercial in order to deliver on the CDP/IDP.\n\n* Responsible for the development and execution of a Program strategic clinical operations plan, taking into account the therapeutic area and underlying science and opportunities for innovation and operational consistency as well as the future clinical, regulatory, and commercial development plan for the molecule. Proactively integrates stage-appropriate needs into the operational strategy. \n\n* Oversees, mentors and works collaboratively with Clinical Study Lead(s) and other clinical operations and supportive roles within the Program (clinical trial managers or associates, quality representative, vendor managers, etc.)\n\n* Overall accountability overseeing and driving CRO and other vendor relationships to ensure execution of clinical studies within the Program, within timelines, budget and with quality\n\n* Participates in departmental and cross functional risk assessment, technology development and process improvement initiatives, including SOP development, review and maintenance.\n\n* Participate/lead in site engagement programs to help build relationships with key opinion leaders, investigators, and clinical site staff to support the clinical study activities and delivery\n\n* Engage with patient advocacy groups to help build patient-focused clinical operations strategies, methods and tools for use in the clinical studies\n\n* Create and implement risk assessment and mitigation plans, performing regular reviews to continually assess for changes\n\n* Attend seminars, congresses, advocacy meetings, Investigator meetings, Program and sub-team meetings, educational conferences/training sessions\n\n* Provide management, training, oversight, coaching, mentoring and development to one or more direct reports\n\n\n\nEducation and Skills Requirements:\n\n\n* Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable.\n\n* Minimum of 10 years experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred)\n\n* Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning\n\n* Demonstration of effective team leadership of matrix teams. Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills\n\n* Experienced in identifying and leveraging relevant data and information to develop well-conceived and executable timelines\n\n* Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred. Experience with rare disease and/or pediatric trials also preferred\n\n* Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery\n\n* Deep operational expertise. Experience planning and delivering global clinical programs and studies\n\n* Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality)\n\n* Experience in participating or facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired\n\n* Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment\n\n* Enjoys building relationships with KOLs and site personnel, with a willingness to travel to establish and build relationships\n\n* Experience with engaging and working with Patient Advocacy groups beneficial\n\n* Experience with hiring, managing, mentoring and/or developing direct reports preferred\n\n* Up to 20% travel, including internationally\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Travel and Senior jobs that are similar:\n\n
$100,000 — $155,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Associate Director Supply Chain Planning
\nRole Summary:\n\nThe Associate Director of Supply Chain Planning is responsible for inventory planning and tracking for Dyne’s end-to-end external supply chain, maintaining a production plan that includes long range planning (LRP), ensuring continuous clinical supply, and commercial launch readiness builds and scenario planning for our assets. This role is instrumental in executing our current supply planning and in helping us develop and implement our future capabilities There role collaborates closely with Process Development, Research, CMC, and Quality Control and Quality Assurance. The person in this role is a strategic and results-driven professional with experience in collaborative supply chain planning. \n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Collaborate with CMC, Logistics, Quality Control, Quality Assurance, and Clinical Operations to develop and maintain a valid demand and supply plan, ensure the availability of products for patients, and support the company’s business objectives\n\n* Maintain an understanding of external manufacturing site capacities, capabilities, and supply risks\n\n* Optimize supply chain processes and drive efficiency\n\n* Scenario planning of demand and supply assumptions as we drive to commercialization\n\n* Lead monthly demand and supply planning meetings with cross functional team members as part of our drive to a formal Integrated Business Planning / Sales and Operations Planning process\n\n* Perform analysis of Dyne portfolio, including inventory projection, supply performance and risks\n\n* Integrate with other global planning processes to monitor key performance indicators (KPIs) and analyze supply chain data to identify opportunities for improvement and cost savings (e.g. Demand, Inventory, Sales and Operations Planning process and Key Performance Indicators )\n\n* Author Supply Chain-related standard operating procedures (SOPs) and work instructions\n\n* Work within Interactive Response Technology(s) to verify and adjust clinical site and depot inventories\n\n* Manage relationships with third-party suppliers and vendors to ensure timely delivery of materials and components\n\n* Implement risk mitigation strategies to address supply chain processes and streamline operations\n\n* Ensure compliance with regulatory requirements and quality standards in supply chain operations\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Bachelor's Degree in Engineering, Supply Chain, Business or related field, or equivalent with 8+ years of related work experience in a biotechnology company\n\n* Ability to effectively plan, prioritize, execute, follow up and anticipate challenges\n\n* Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments\n\n* Ability to work, influence, and gain agreement across multiple functions (Manufacturing, Quality and CMC)\n\n* Strong analytical, problem solving and critical thinking skills\n\n* Strong knowledge of supply chain best practices, inventory management, and demand forecasting\n\n* Expertise in use of MS Excel, as well as demonstrated proficiencies in Smartsheet, Visio, ERP systems and Power BI (or similar application)\n\n* Collaborative work style to be part of a team to identify process gaps and develop solutions\n\n* Excellent interpersonal, verbal, and written communication skills\n\n* Advanced analytical and problem-solving skills\n\n* Experience in working with CMC Teams\n\n* Experience in supply chain, drug development, project management, and/or pharmaceutical manufacturing/packaging\n\n* In-depth working knowledge of regulations relating to clinical manufacturing, packaging and distribution activities (CGMP, GCP)\n\n* APICS or CSCMP certification a plus\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Sales and Non Tech jobs that are similar:\n\n
$47,500 — $81,250/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Neuromuscular Research Co Op
\nRole Summary:\n\nThe Co-Op in the Neuromuscular Research Group will be trained in a variety of lab techniques and will support analysis of biological samples. The individual will be an integral team member and contribute to the understanding of molecular and cellular phenotypes of in vitro and in vivo models of neuromuscular diseases, discovery and characterization of potential therapeutic compounds using relevant models. The individual will have the opportunity to learn key aspects of discovery research in an intellectually stimulating environment.\n\nThis role is for a period of 6 months, beginning in July.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Executing both manual and automated extraction of nucleic acids and proteins from biological samples\n\n* Performing qRT-PCR and protein-based assays to assess gene and protein expression in biological samples\n\n* Performing routine cell culture and cell-based assays\n\n* Maintaining accurate and clear records of experimental work\n\n* Supporting histology and microscopy workflow\n\n* Analysis of data and communicating findings to team members\n\n* Participating in experimental design, optimization of relevant assays, and literature review\n\n\n\n\n \n\nEducation and Skills Requirements:\n\n\n* BS/MS and/or pursuing a degree in a biological discipline\n\n* Previous hands-on experience with molecular biology techniques is desired but not required; more specifically:\n\n\n* Handling biological samples\n\n* Sterile techniques and routine cell culture\n\n* Nucleic acid extraction and gene expression analysis\n\n* Protein isolation\n\n\n\n\n\n* Willingness to learn and strong work ethic\n\n* Excellent organizational skills and ability to work in a team\n\n* Ability to communicate ideas clearly and document efforts in the lab\n\n* Knowledge of software applications such as Prism, Excel, and PowerPoint\n\n\n\n\n#LI-Onsite
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Research Data Sciences Co Op
\nRole Summary:\n\n\n\nThe Data Sciences team at Dyne Therapeutics is seeking a Co-Op student to participate in research on innovative therapeutics for rare neuromuscular disease. You will apply your computational skills to the engineering and analysis of data in our drug discovery programs. You will apply your skills in machine learning and data engineering on complex multi-omics and preclinical datasets. In partnership with biology and bioinformatics scientists, you will contribute to insights about novel therapeutic mechanisms and their impact on disease. The successful candidate will be collaborative, detail-oriented, enjoy learning new skills and working in a fast-paced environment.\n\nDyne’s Co-Op Program offers students the opportunity to learn and work at a cutting-edge company in the biotech industry. Through the course of the co-op, you will gain a broad understanding of a variety of experimental and bioinformatics research methods in therapeutic discovery and development.\n\nThis role is for a period of 6 months, beginning in July.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area. \n\n \n\nPrimary Responsibilities Include:\n\n\n\n\n* Implementation of computational methods and data engineering for omics data sets such as Next Generation Sequencing (NGS). \n\n* Evaluation of computational methods for classification of therapeutic R&D data for understanding of patient population and disease biology. \n\n* Management, integration, and visualization of preclinical and translational data.\n\n* Analytical method development with regular communication of progress to the project team and accurate documentation of technical work.\n\n* Presentation of learnings and findings at the end of the Co-Op term\n\n\n\n\n \n\nEducation and Skills Requirements:\n\n\n\n\n* Undergraduate student in a relevant field, such as bioinformatics, cheminformatics, applied mathematics, or computer science or equivalent experience \n\n* Programming experience in R and/or Python; familiarity with code management and notebook IDE such as jupyter \n\n* Experience with statistical and machine learning methods, such as supervised and unsupervised classification\n\n* Interest in working with biological data types, such as biomolecular sequence, transcriptomics and proteomics\n\n* Understanding of relational databases, SQL, json, or other data management structures\n\n* Strong organizational skills and solid written and oral communication \n\n\n\n\n\n\n#LI-Onsite
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Chief Information Officer
\nRole Summary:\n\nThe Chief Information Officer (CIO) is a key role responsible for defining and evolving Dyne’s technology and digital strategy, vision, and roadmap in line with the business strategy, to drive innovation, efficiency, and competitive advantage to enable organizational success, growth, and commercial readiness. This role requires an understanding of and deep experience with the full drug development lifecycle from research and development through commercialization. This role requires a strategic leader experienced with preparing an organization’s integrated technology infrastructure for commercialization and taking products to market. This leader is responsible for developing an IT roadmap, identifying, and executing on initiatives that drive tangible business outcomes that accelerate drug development timelines, ensure data integrity, compliance, and operational effectiveness.\n\nThis is a full-time position based in Waltham, MA without the possibility of being remote.\n\nPrimary Responsibilities Include:\n\n\n* Collaborate closely with cross-functional leaders to develop comprehensive strategies that drive business success and operational excellence, optimizing product development, and establishing commercialization processes\n\n* Align technology initiatives with the overarching business objectives, guaranteeing that Dyne’s corporate technology supports its operations and objectives including digital transformation, cybersecurity, and commercial readiness\n\n* Provide the strategies and technology solutions to enable the launch of products globally\n\n* Implement commercial, manufacturing and supply chain, and ERP business processes and systems\n\n* Lead and grow a strong global IT team, fostering a culture of innovation, collaboration, and continuous improvement, providing mentorship and professional development opportunities to team members to enable efficient and scalable operations, with particular focus to building of commercial capabilities\n\n* Define the operating model to enhance IT's capabilities\n\n* Continue to scale robust governance protocols to ensure product/platform compliance, policy development, and management of risks\n\n* Continue to scale a robust IT Security organization to protect Dyne’s assets and ensure global regulatory and privacy compliance\n\n* Evolve the cross-functional technology governance body to ensure alignment of technology and business goals\n\n* Develop an enterprise AI Strategy and prioritization framework and an enterprise data management strategy including retention and governance standards\n\n* Evolve and right size the ITGC, IT SOX, and SEC Cybersecurity controls\n\n* Responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation of validated computer systems.\n\n* Partner with Finance to develop and lead the IT portfolio budget, ensuring sufficient resources are allocated for technology investments, returns are realized, and future investments are balanced across business needs, while providing a stable and efficient support operating model\n\n* Direct the development of the IT sourcing strategy and provide executive oversight for strategic vendor and partner relationship management\n\n* Provide strategic direction for cybersecurity program using a risk-based approach, direct internal and external services to execute on a proactive strategy, and ensure program agility to adapt to and evolving threat landscape\n\n* Drive commercial readiness in IT processes and related business processes to ensure business achieves timely benefits from investments\n\n* Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are optimized for business needs, operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines\n\n* Foster strong relationship[s, including proactive planning and cultivation of external partnerships\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Bachelor's degree or equivalent experience in technology or related field\n\n* Twenty plus (20+) years related experience, including 5+ years as a strategic IT executive within a biotech\n\n* Commercial biotech build experience across commercial, manufacturing and supply chain, and ERP business systems in a strategic, head of IT or CIO role\n\n* Demonstrated initiative and ability to navigate ambiguity, and the ability to grow as the company scales in size\n\n* Experience building a commercial ready IT infrastructure, processes, and controls\n\n* Working expertise of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance\n\n* Expert knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization\n\n* Ability to translate business needs into a strategic IT roadmap, communicate that roadmap at all levels of the organization, and effectively implement that roadmap into operational success for the organization\n\n* Experience supporting all levels, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals\n\n* Expert knowledge of vendor management and technology business management processes and methodologies\n\n* Extensive experience with software development life cycle in regulated environment\n\n* Excellent communication skills (verbal, written, presentation) and ability to communicate well with stakeholders at all levels\n\n* Ability to lead both independently and in a team-oriented, collaborative environment\n\n* Ability to conform to shifting priorities, demands and timelines through analytical, and problem-solving capabilities\n\n* Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors\n\n\n\n\n \n\n \n\n \n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Finance and Senior jobs that are similar:\n\n
$70,000 — $130,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Associate Director Clinical Scientist
\nRole Summary:\n\nThe Associate Director, Clinical Scientist is a key member of the Clinical Development team for the planning, conduct, analysis, and reporting of clinical studies. The person in this role plays a key role in designing, implementing, and managing clinical trials to evaluate novel therapies for patients with rare muscle diseases. The person in this role works independently and in collaboration with the Clinical Development Lead and other cross-functional team members in the execution of clinical trial protocols, analysis of clinical trial data, review of regulatory documents, and summary of key data for internal and external presentations.\n\nThis role is based in Waltham, MA without the possibility of being remote.\n\nPrimary Responsibilities Include:\n\n\n* In collaboration with the Clinical Development Lead, be accountable for the scientific aspects of the design, implementation, and conduct of clinical trials with both internal and external stakeholders (e.g., investigator meeting presentations, data reviews and summaries, protocol deviation reviews, etc.)\n\n* Contribute to the development of clinical trial protocols, including study design, site selection, patient recruitment strategies, and protocol amendments in close collaboration with the Clinical Development Program Lead and cross-functional team members\n\n* Contribute to the creation and amendment of study-level documents, including drug handling and administration documents, physical therapy manuals, clinical study reports, and preparation of clinical sections of key regulatory documents, including Investigator’s Brochures, briefing books, and submission dossiers\n\n* Collaborate with cross-functional teams including medical affairs, regulatory affairs, biostatistics, and clinical operations to ensure successful planning and execution of clinical trials\n\n* Provide scientific expertise and guidance on study design, data analysis, and interpretation of clinical trial results\n\n* Monitor study progress, identify risks and issues, and develop mitigation strategies to ensure timely and successful completion of clinical trials\n\n* Contribute to high quality clinical safety and efficacy data review and identify clinical data insights through ongoing patient-level review and trends analysis\n\n* Assist with review and interpretation of clinical study data and production of both internal and external facing data presentations\n\n* Contribute to regulatory submissions, including INDs/CTAs, briefing documents, and responses to regulatory queries\n\n* Collaborate with key opinion leaders and investigators to support scientific discussions and presentations\n\n* Assist and collaborate with cross-functional team members to maintain clinical development plans aligned with key strategic goals of the Company\n\n* Stay abreast of the latest scientific developments and therapeutic advances in rare muscle diseases to inform clinical development strategies\n\n\n\n\n \n\nEducation and Skills Requirements:\n\n\n* Advanced degree (PhD, MD, PharmD) in life sciences/ healthcare (or clinically relevant degree).\n\n* 8+ years of experience in clinical development in the pharmaceutical or biotechnology industry, with a focus on rare diseases preferred.\n\n* 3+ years as a Clinical Trial Scientist or comparable role\n\n* Strong familiarization with Good Clinical Practice (GCP) and drug development processes\n\n* Expertise in neuromuscular disease biology and rare disease experience strongly preferred\n\n* Strong knowledge of clinical trial design, execution, and regulatory requirements\n\n* Experience in designing and implementing clinical trials for rare diseases is highly desirable\n\n* Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution\n\n* Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, PowerPoint, Veeva CRM) for data collection, analysis and reporting\n\n* Ability to effectively prioritize tasks and comfortable working highly independently in a cross-collaborative matrix environment\n\n* Excellent communication skills with the ability to collaborate effectively with cross-functional teams and external stakeholders\n\n* Proven ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment\n\n* Flexibility for travel both domestically and internationally for trial site visits, meetings, conferences, etc.~20% travel\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Travel and Non Tech jobs that are similar:\n\n
$95,000 — $136,250/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Senior Scientist Bioanalysis
\nRole Summary:\n\nThis role plays a critical role in advancing our pipeline of novel treatments through the application of cutting-edge bioanalytical techniques. This includes designing, developing, optimizing, and validating bioanalytical in complex biological matrices with a focus on muscle tissue and fluids. The person in this role is expected to utilize state-of-the-art LC-MS/MS instrumentation for the quantitative analysis of biomarkers, metabolites, and therapeutic compounds in preclinical and clinical samples.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Candidates must be able to relocate.\n\nPrimary Responsibilities Include:\n\n\n* Provide bioanalytical support for portfolio, including complex method development and troubleshooting for PK and immunogenicity assays across several programs.\n\n* Collaborate cross-functionally with Platform, Research and Non-Clinical teams.\n\n* Design, develop and/or optimize sensitive quantitative assays to measure Dyne proprietary drugs in different matrices (plasma, urine, tissues) and from different species (rodents, non-human primates, human).\n\n* Setup and maintain lab instrumentation.\n\n* Evaluate assay performance, ability to troubleshoot issues.\n\n* Perform data analysis and interpretation.\n\n* Track progress against project timelines, generate regular status updates, and communicate progress and issues to management.\n\n* Maintain a well-documented laboratory notebook.\n\n* Effectively manage workload with minimal supervision.\n\n* Adhere to safe laboratory practices.\n\n* Multi-task across several projects and manage time effectively to achieve results.\n\n* Collaborate to identify external vendors (CRO) for new outsourced projects and request contracts.\n\n* Transfer bioanalytical assays to CROs, oversee assay validation and sample testing. \n\n\n\n\nEducation and Skills Requirements:\n\n\n* BS or MS in Pharmaceutical sciences with at least 6-8 years of experience in the pharmaceutical industry or PhD degree with at least 4 years of industry experience\n\n* Broad, and in-depth knowledge of FDA bioanalytical guidance to industry\n\n* Hands-on assay development experience with different ligand binging assay formats and detection methods required\n\n* Strong assay troubleshooting, data analysis and interpretation skills\n\n* Excellent verbal and written communication skills\n\n* Ability to work collaboratively in a team-oriented environment\n\n* Strong attention to detail, organizational skills, and ability to multitask\n\n* Demonstrated ability to troubleshoot and solve problems\n\n\n\n\n \n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote SVP Head of Clinical Development
\nRole Summary:\n\nThe SVP, Head of Clinical Development will provide strategic direction and technical leadership to the clinical development team including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This individual will provide strategic leadership for the clinical and medical aspects and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products. The role is responsible for overseeing trials in clinical development and pharmacovigilance according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs. The Head of Development will act as a cross functional advisor and will work closely with the internal and/or external Clinical Development, Pharmacovigilance, biostatistics group(s), R&D, Regulatory, and the Commercial Development teams to execute clinical trial strategy and design.\n\nThis role is based in Waltham, MA without the possibility of being remote. \n\nPrimary Responsibilities Include:\n\n\n* Design and oversee execution of multi-layered clinical development strategies\n\n* Maintain compliance with regulatory guidelines, that identify opportunities for breakthrough therapy designation and accelerated approval while identifying subsequent opportunities for label expansion\n\n* Inform global registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authorities\n\n* Manage drug safety and pharmacovigilance activities for ongoing trial(s)\n\n* Prepare clinical portions of IND submissions and BLAs, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios\n\n* Rapidly integrate new insights from on-going in-house or external clinical trials, translational science into development plans and clinical trial activities\n\n* Create compelling data presentations for external disclosures\n\n* Collaborate with research leadership and drug discovery teams to shape the company’s drug discovery portfolio\n\n* Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings\n\n* Establish and maintain relationships with external companies (such as CROs), investigators and opinion leaders to optimize performance on clinical trial activities\n\n* Prepare manuscripts for technical journals and make presentations at scientific meetings\n\n* Work collaboratively with Research to provide input into design of preclinical studies to support drug products entering or in the clinic and by helping initiate IND submissions\n\n* Provide input to evaluate products for in licensing/out licensing\n\n* Participate in business development processes as needed\n\n* Provide clinical portion of regulatory documents such as Investigator Brochure updates, and Drug Safety Update Reports\n\n* Manage and be responsible for pharmacovigilance for clinical projects including review and reporting with support from the pharmacovigilance team\n\n* Provide leadership and guidance for the clinical development team to ensure efficient execution to meet deliverables and timelines\n\n* Oversee medical monitor activities for all phases of studies through direct execution of activities or supervision of a medical monitor\n\n\n\n\n Education and Skills Requirements:\n\n\n* PhD, PharmD, or MD required\n\n* 20+ years of progressive relevant experience within the biopharmaceutical/biotech industry in translational medicine/biology, clinical pharmacology or directly related discipline, preferably in the biopharmaceutical/biotech industry\n\n* Experience in design and executing clinical trials; protocol development and design, development of case report forms, and statistical analysis plans; experience in rare disease drug development is preferred\n\n* Demonstrated scientific and business acumen and the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activities\n\n* Provide clinical support and work with other members of the leadership team to develop and communicate the overall corporate strategy\\n\n* Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials\n\n* Strong knowledge and experience across all phases of drug development\n\n* Liaise with drug discovery, pharmacology, research and toxicology as necessary in order to finalize a pre-clinical program which will permit the most efficient clinical development of new chemical entities within the framework of the project team\n\n* Propose upon consultation with clinical operations pragmatic solutions to ensure the efficient ethical & quality conduct of clinical trials\n\n* Experience writing and reviewing clinical sections of study reports and regulatory documents (IND, BLA, MAA)\n\n* Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be “hands on”\n\n* Start-up/small company experience required, with willingness to be hands-on\n\n* Demonstrated ability to manage multiple complex projects and programs simultaneously\n\n* Excellent attention to details, critical thinking, and data interpretation\n\n* Strong communication (oral and written) and interpersonal skills\n\n* Excellent organizational, multi-tasking and collaboration abilities\n\n\n\n\n \n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$55,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Senior Director Translational Biomarkers
\nRole Summary:\n\nThe Senior Director, Translational Biomarkers supports the development of Dyne’s translational strategy for programs currently in late research/early development working collaboratively with cross functional team members. This role is responsible for designing and execution of preclinical and clinical development plans in terms of endpoints and biomarkers with a focus on quick win/fail early strategies and early proof of concept. This individual also builds strategies to establish surrogates to enable later stage development. This position works collaboratively across therapeutic areas and research teams to ensure planning, execution, and delivery of the strategy for clinical trials conducted by Dyne.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Develop experimental and translational medicine study designs to evaluate disease heterogeneity, mechanism of action for disease treatment or prevention\n\n* Develop a biomarker strategy to support clinical development for early-stage clinical programs\n\n* Lead the clinical prioritization of biomarkers for early clinical development programs for early proof-of-concept and late-stage clinical development\n\n* Develop and provide input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes\n\n* Assist in the selection of clinical diagnostic biomarkers and explore new technologies through collaboration and partnerships, internal and external\n\n* Evaluate technologies to identify, define and implement clinical biomarker strategies to support the clinical development of Dyne’s programs\n\n* Author the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-author, assist and support the development of publications, abstracts, and presentations\n\n* Partner with biostatisticians and computational experts to ensure delivery and interpretation of high-quality data to support internal decision-making and health authority filings\n\n* Partner closely with cross-functional experts in Research, Non-Clinical/Pre-Clinical, Clinical Development, Biostatistics, Bioinformatics, Regulatory, and external partners\n\n\n\n\nEducation and Skills Requirements:\n\n\n* M.D. or Ph.D. required with at least 15 years of experience in the pharmaceutical/biotechnology industry or equivalent government/academic experience\n\n* Experience with rare disease development or related science focus is required\n\n* Experience designing and building clinical development plans preferred\n\n* Thorough understanding of rare muscle diseases, with experience integrating novel endpoints and biomarkers into clinical trials\n\n* Must be familiar with scientific methods including assays (binding and cell based), flow cytometry, transcriptomics, sequencing, and diagnostic assays\n\n* Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure\n\n* Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Non Tech jobs that are similar:\n\n
$35,000 — $71,250/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Senior Scientist Oligonucleotide Chemistry
\nRole Summary:\n\nAs a member of the Platform Oligo innovation team, the successful candidate will contribute to the development of Dyne’s oligonucleotide chemistry platform and enable the discovery of novel oligonucleotide therapeutics. This individual will be responsible for building an internal oligonucleotide chemistry lab and will lead the design, synthesis, purification, and analysis of oligonucleotides and their conjugates. The position requires a combination of deep technical expertise in oligonucleotide synthesis and in-depth knowledge of oligonucleotides as a therapeutic modality.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Independently perform solid phase synthesis of oligonucleotides with diverse sugar and backbone modifications at various scales\n\n* Troubleshoot and optimize synthesis methods to produce high quality oligonucleotides of various lengths\n\n* Perform purification (anion exchange, reverse phase), analysis (HPLC/UPLC), characterization (LCMS, UV, melting temperature) of oligonucleotides and their conjugates\n\n* Explore novel chemistries and designs to improve the DMPK and safety properties of oligonucleotides\n\n* Manage hit-to-lead optimization process and deliverables\n\n* Interact with the biology and preclinical groups to deliver clinical candidates\n\n* Multi-task across several projects and manage time effectively to achieve results\n\n* Collect, present, and discuss data at internal team meetings\n\n\n\n\nEducation and Skills Requirements:\n\n\n* PhD in chemistry or related discipline with a minimum of 4 years of experience in oligonucleotide synthesis -prior postdoctoral experience is preferred- or MSc with at least 7 years of industrial experience in the biotechnology industry\n\n* Strong experience with the operation of oligonucleotide synthesis machinery (Mermade), and AKTA purification unit\n\n* Working knowledge of RNA biology to enable collaboration across functions\n\n* Experience with ASO, siRNA or other DNA/RNA targeting modalities\n\n* Experience in nucleoside chemistry and bioconjugation are a plus\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Director Regulatory Affairs
\nRole Summary:\n\nThe Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs. The person in this role must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases is a must.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\nPrimary Responsibilities Include:\n\n\n* Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings\n\n* As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals\n\n* Oversee preparation, review, and submission of regulatory documents maintaining compliance with regulatory requirements.\n\n* Manage timelines and preparation of meeting requests and briefing documents\n\n* Author/edit documents to support regulatory submissions\n\n* Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements\n\n* Manage and ensure compliance with all reporting requirements, including annual and periodic reports\n\n* Support the organization with health authority meetings\n\n* Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc)\n\n* Manage staff and vendors as needed to support regulatory activities\n\n* Assist with SOP generation\n\n* Perform other duties as required, interfacing with other departments, CROs and external vendors as needed\n\n\n\n\nEducation, Knowledge & Skill Requirements\n\n\n\n* Minimum of a bachelor’s degree in life science or related discipline is required\n\n* Minimum of 8-10 years of experience in regulatory strategy in a clinical-stage biotechnology company\n\n* Strong experience with CTD format and content regulatory filings\n\n* Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements\n\n* Experience in Health Authority Meetings\n\n* Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus\n\n* Ability to work independently to manage multiple projects in a fast-paced environment\n\n* Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones\n\n* Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management\n\n* Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior, Marketing and Non Tech jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Vice President Head of Compliance
\nRole Summary:\n\nIn this role, the Head of Compliance will design, implement, and administer a comprehensive compliance program appropriate to the size and stage of Dyne that is scalable as Dyne transitions to a commercial stage company. The Head of Compliance also will act as the primary resource for healthcare law legal counseling across the entire organization. The person in this role will work out CEO and Board of Directors\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Responsible for establishment and leadership of an effective global healthcare compliance program\n\n* Strategic compliance advisor to the Board of Directors and the management team\n\n* Healthcare law and data privacy legal advisor to the entire company\n\n* Responsible for the compliance program with respect to data privacy/protection, anti-bribery, and corporate compliance.\n\n* Senior member of the Legal & Compliance team, a highly visible representative for the team\n\n* Design, implement and maintain an effective global healthcare compliance program encompassing compliance with healthcare laws and ethical codes\n\n\n* Engage employees, management and Board with the compliance agenda, its strategic importance to the business and its relationship to our values and goals;\n\n* Design, implement, administer, and continuously improve an effective global healthcare compliance program, including policies and procedures, compliance committees, training, communication, monitor and auditing, enforcement, and investigations\n\n* Design, implement, and maintain system to check for excluded individuals/entities;\n\n* Review and advise on publications, promotional / pre-promotional materials, presentations, and agreements concerning dealings with Healthcare Professionals (HCPs), patients, patient advocacy groups, payors, and reporting.\n\n\n\n\n\n* Responsible for the compliance program with respect to data privacy/protection, anti-bribery, and corporate compliance in partnership with other subject matter experts and functional leads\n\n* Responsible for implementing and conducting price and transparency reporting\n\n* Responsible for providing legal advice to the organization on pre-commercial and commercial healthcare law issues as well as data privacy issues\n\n* Responsible for managing any external resources that may be required, ensuring company receives high-quality advice on time and on budget\n\n* Stay connected across the business in a monitoring role to identify and proactively address compliance issues\n\n* Support the Head of Legal in compliance and healthcare law matters as well as administrative matters\n\n* Grow and mature the Compliance function and the Healthcare legal function\n\n\n\n\nEducation and Skills Requirements:\n\n\n* JD from accredited law school and license to practice in at least one US jurisdiction; compliance certification preferred\n\n* Minimum of 15 years of experience in healthcare compliance and healthcare law, preferably with experience in a clinical-stage biotechnology company and a top-tier law firm\n\n* Comprehensive knowledge of and experience in all US compliance topics\n\n* Experience with compliance regimes outside of the US in major ex-US markets\n\n* Experience with data privacy (g., GDPR, state privacy laws)\n\n* Experience in an in-house role\n\n* Experience interacting with a management team and/or a Board of Directors\n\n* Experience in the design and implementation of a healthcare compliance program for a growing biotechnology company\n\n* Proven self-starter and multi-tasker in a fast-paced environment\n\n* Excellent communication, writing and computer skills\n\n* Ability to collaborate well with internal and external stakeholders\n\n* Excellent analytical, organizational and information-seeking skills; detail oriented\n\n* Exceptional business judgment, with the ability to think strategically and give practical advice while balancing business needs with legal risks\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Legal jobs that are similar:\n\n
$55,000 — $145,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Associate Director Quality Assurance Operations
\nRole Summary:\n\nThe Associate Director, Quality Assurance (QA) Operations role will be the QA technical lead on a selection of external manufacturing and testing project teams and responsible to develop, establish, and maintain Quality Systems, Procedures, Policies and Metrics that support those external manufacturing activities in conjunction with the Director of QA Operations. This role will provide leadership for applicable quality operation activities and proactively assess compliance issues and risks serving as an expert GMP consultant for issue management & issue escalation, with a focus on critical and major quality events. The Associate Director QA Operations role will participate in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality operations.\n\nThis role will work closely with key stakeholders including CMC, Regulatory Affairs, and Project Management.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate.\n\n \n\nPrimary Responsibilities Include:\n\n\n* Oversee release activities for Drug Substance Intermediates (DSI) including batch record review/release activities\n\n* Represent Dyne QA Operations at CMO meetings\n\n* Ensure that contract manufacturing activities are aligned with current regulatory requirements, standards, and industry trends\n\n* Work within and improve the internal framework for the review of batch records and ensure that any compliance issues are addressed in a timely manner\n\n* Manage CMO documentation and files for internal access\n\n* Lead or support CMC investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness\n\n* Participate in CMO Quality Agreement review\n\n* Support change management actions that directly impact manufacturing and/or testing\n\n* Provide input for DSI specifications, stability protocols, and product labeling as needed\n\n* Participate in domestic and international audits of CMO sites\n\n* Support on-site internal auditing program by assisting with audits when required\n\n* Develop and monitor metrics (KPIs) for Quality Operations for Management Review\n\n* Provide QA operations training to teammates\n\n* Support investigational new drug applications and related correspondence from global regulatory authorities\n\n\n\n\n \n\nEducation and Skills Requirements:\n\n\n* Bachelor’s degree/master’s degree in engineering, Science, or relevant discipline\n\n* Minimum of 8 years’ experience in related cGMP environment (Bioconjugate manufacturing preferred)\n\n* Minimum of 5 years of related work experience in Quality Assurance or closely related role within Biopharmaceutical regulated industry, preferably with experience overseeing CMO/CDMO organizations\n\n* Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations\n\n* A proven track record of demonstrating good judgement & decision-making experience\n\n* Excellent organizational skills\n\n* Ability to concisely present quality events and the criticality to internal stakeholders\n\n* Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues\n\n* Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA\n\n* A working knowledge of the muscle disease therapeutic industry would be beneficial\n\n* Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources to deliver consistently\n\n* Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods\n\n* Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet to all QA activities when required\n\n* Proficiency with software applications such as MS Office, Smartsheet, Veeva a plus\n\n* Up to 15% travel\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Testing and Testing jobs that are similar:\n\n
$50,000 — $75,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Associate Director Regulatory Operations
\nRole Summary:\n\nThis role is accountable for managing the submission activities and supporting development of Regulatory Operations practices. The Associate Director of Regulatory Operations is responsible for the assembly, publishing, and submission of regulatory filings to global Health Authorities (HA) in an efficient and timely manner. This role will drive efficiencies in both submission and RIM activities with creative thought process to support improvements and long-term vision of the group.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Serve as an administrator for RIM and provide direct support to functional disciplines and program teams responsible for developing submission contents\n\n* Manage day-to-day submission activities both internally and in collaboration with business partners\n\n* Organize, archive and track Health Authority correspondences, submissions, and questions/commitments\n\n* Partner with Regulatory Leads to provide input into scheduling and planning of submissions\n\n* Provide project management support in generation of timelines for Regulatory interactions and submissions\n\n* Provide document formatting and report level publishing and compilation support\n\n* Provide insights to ensure streamlined end-to-end content generation and submission publishing process\n\n* Maintain up-to-date guidance knowledge and industry standards to ensure all regulatory submissions are compliant and effective to HA reviewers\n\n* Develop and maintain Standard Operating Procedures, training materials, and job aids\n\n* Support in maintaining content repositories for external collaboration, project management, regulatory intelligence\n\n* Participate in change management activities in building optimal usage of the regulatory systems\n\n* Foster collaborative relationship with business partners and manage contracts, budgets and invoices as needed\n\n* Perform other regulatory related duties as assigned\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Minimum of a BA/BS degree\n\n* Minimum of 8 years of experience in eCTD/submission publishing and Regulatory Operations, preferably in a clinical-stage biotechnology company\n\n* Able to display excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory operation strategies\n\n* Able to demonstrate flexibility and accountability and identify potential issues and mitigate risks\n\n* Thorough knowledge in eCTD, validation criteria, data standards, submission standards and requirements\n\n* Experience with document formatting and authoring templates\n\n* Knowledge in authoring and publishing in Veeva RIM. Experience in Business or System Administrator is a plus\n\n* Experience in RIM process and question/commitment tracking\n\n* Experience in compiling both US and ex-US submissions\n\n* Experience with change management and validation of GxP computerized systems\n\n* Experience with managing consultants and partners\n\n* Able to proactively support and consult colleagues for guidance and training in business process, EDMS, and submission standards, as necessary\n\n* Able to work with strategic deadlines and adapt quickly to changing requirements and priorities\n\n* Attention to detail\n\n* Embrace Dyne’s core values and culture\n\n* Excitement about the vision and mission of Dyne\n\n\n\n\n#LI-Onsite
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Veterinary Pathology Intern
\nRole Summary:\n\nThere will be two activities that the intern will be involved in: \n\nThe intern will review data from cynomolgus monkey toxicology studies completed by Dyne and tabulate findings across studies producing a slide deck that catalogs the similarities and differences between studies. The objective is to identify findings that are common across studies as well as those that are unique to a given therapeutic. They will review scanned histology slide images from these studies using the Patholytix histology slide image system as well as study reports and data sets.\n\nThe intern will become familiar with cynomolgus monkey tissue histology, background lesions as well as findings associated with biologics and oligonucleotides. They will also become familiar with the use of digital pathology to evaluate histology slides, which is becoming an industry standard practice. They will learn how both clinical and anatomic pathology data is interpreted and summarized in the context of human risk assessment of a novel therapeutic.\n\nThe second objective will be focused on evaluating the effect of a novel Dyne therapeutic in a mouse pharmacology model. They will use histologic, histochemical, immunohistochemical and or biochemical methods to assess the impact on tissue and track the distribution of the therapeutic in tissue. They will participate in the conduct of a short-term rodent study including the collection of tissue and processing to achieve these objectives.\n\nThe intern will gain experience in the conduct of an animal study, the collection and processing of tissues for histologic and biochemical evaluation, and methods for histologic and biochemical evaluation of tissue. \n\nThe intern will work with Dyne pathology, histology, and animal pharmacology staff. The intern will be expected to summarize their findings from both activities in a slide deck and / or poster and make an oral presentation to Dyne colleagues.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area. This role will be for an 8 to12 week period in May to August 2024\n\nPrimary Responsibilities Include:\n\n\n* Review digital histology slides and study data to identify and tabulate similarities and differences between cynomolgus monkey toxicology studies.\n\n* Perform tissue processing, staining and evaluation of microscopic alterations in tissues from a mouse pharmacology study.\n\n* Summarize and present data to Dyne colleagues.\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Must have completed undergraduate training and be enrolled in a Doctor of Veterinary Medicine degree program with 2 years completed.\n\n* The ideal candidate will have demonstrated an interest in pathology as a possible career through their involvement in pathology related activities and / or participation in the pathology club associated with their institution.\n\n* Applicants in the 4th year of their veterinary medicine degree curriculum as well as in a veterinary pathology residency will also be considered.\n\n* A cover letter describing the applicant’s interest in pathology and curriculum vitae is required at time of application.\n\n\n\n\n \n\n#LI-Onsite
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Director Biostatistics
\nRole Summary:\n\nThe Director, Biostatistics will provide leadership and guidance for clinical development program(s). This person will be responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions. The ideal candidate must be a good communicator, exhibit high-energy, self-motivation, and forward‑thinking. Experience working in rare disease is desirable.\n\nThis role is based in Waltham, MA without the possibility of being a remote role.\nPrimary responsibilities include:\n\n\n* Serve as a biostatistics expert for assigned clinical studies or compound-level activities\n\n* Effectively interact with members in other functions including medical, regulatory, safety, clinical operation, and translational medicine for strategic planning to ensure optimized clinical development in accordance with corporate objective\n\n* Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables\n\n* Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles\n\n* Design and specify stratification /randomization schema; review and approve test randomization lists\n\n* Collaborate with Data Management, Clinical Development and Clinical Operations on design and review of eCRFs, and ensure data collection meet the requirements of statistical analyses\n\n* Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), provide guidance to statistical programmers on SDTM/ADaM and oversee the development of shells for tables, figures and listings\n\n* Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents\n\n* Validate the results of key statistical deliverables\n\n* Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.\n\n* Perform ad hoc and exploratory statistical analyses as needed\n\n* Be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions\n\n* Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs\n\n* Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations\n\n* Represent Dyne regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners\n\n* Identify and implement emerging new ways of doing clinical development and new methodologies\n\n* Contribute or lead standardization and process improvement efforts for Biostatistics function and contribute to cross-functional process improvement efforts\n\n\n\nEducation and Skill Requirements:\n\n\n* Ph.D. in statistics or Biostatistics or equivalent with at least 8 years of experience in the pharmaceutical or biotech industry\n\n* Interest in and basic understanding of biology and biological process including ASO and siRNA\n\n* Demonstrated ability and experience in the design, analysis and reporting of clinical trials\n\n* Experience in NDAs, MAAs or other regulatory submissions desirable\n\n* In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches\n\n* Knowledge of FDA, EMA and ICH regulations and guidelines\n\n* Proficient in statistical programming (SAS is required and R is a plus)\n\n* Experience with trial design software (e.g., EAST)\n\n* Ability to concurrently lead statistical efforts for multiple studies\n\n* Understanding of data standards, including SDTM and ADaM\n\n* Adept at overseeing statistical services provided by CRO’s and/or contractors\n\n* Ability to work independently and act with initiative to address issues\n\n* Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally.\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Design jobs that are similar:\n\n
$30,000 — $70,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Senior Research Associate Platform Development
\nRole Summary:\n\nThe Senior Research Associate, Platform Development works on bioconjugation of proteins and oligonucleotides to help advance Dyne’s therapeutics research and support our drug discovery programs. The successful candidate will work within a group of bioconjugate chemists, biochemists, and analytical scientists, generating and presenting their own data. They will also collaborate closely with cross-functional drug discovery and development teams to represent the Platform Development function and contribute to the advance of Dyne’s oligonucleotide delivery platform and therapeutic pipeline.\n\nThe person in this role is an ambitious and energetic self-starter, is motivated to apply their skills and creativity to drug discovery and enjoys working in a fast-paced team setting.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.\n\nPrimary Responsibilities Include:\n\n\n* Independently plan and execute multistep bioconjugation reactions to deliver protein-oligonucleotide conjugates, including\n\n\n* Preparation of activated oligonucleotides and APIs\n\n* Execution of protein-oligonucleotide conjugations across protein and payload classes up to multi-gram scale\n\n* Purification of protein conjugates utilizing AKTA FPLC systems with a variety of different chromatography modes (including CHT, HIC, etc.)\n\n\n\n\n\n* Perform biochemical analysis on in-process and final purified conjugates including the following techniques: mass spectrometry (MS), CE-SDS, SDS-PAGE, BCA, SEC-HPLC, and UV-vis\n\n* Perform Tangential Flow Filtration (TFF)\n\n* Maintain an electronic lab notebook in a timely manner and contribute to company intellectual property\n\n* Communicate experimental results to a diverse audience of scientific collaborators\n\n* Serve as functional area representative on cross-functional drug discovery teams\n\n* Write technical reports to support documentation and technical transfer\n\n* Contribute to critical discussions of therapeutic structure, function, and new targets\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Minimum of a B.Sc in chemistry, chemical biology, or biochemistry and 4 years of experience in drug discovery and development, preferably at a clinical stage biotechnology company; or M.Sc and 2 years of experience\n\n* Demonstrated understanding of the general principles of chemistry/biochemistry\n\n* Demonstrated proficiency in synthesis, purification, and characterization of protein bioconjugates\n\n* Demonstrated track record of contributions to research including the ability to work independently and troubleshoot experiments\n\n* Demonstrated ability to collaborate and contribute to an inclusive and high-functioning team\n\n* Understand published scientific literature outside of his/her immediate area of expertise and apply this understanding to drive innovation\n\n* Prepared scientific publications or regulatory submission documents\n\n\n\n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$60,000 — $100,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
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