\nThe Director/Senior, Clinical Development will provide scientific and technical expertise for assigned clinical programs and will bring experience in designing and conducting clinical trials.  This position has primary responsibilities for setting strategy across the clinical development program, oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies.  \n\n\n\nWhat you'll do: \n* Contribute as team leader and author in protocol development, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, interactions with US and Global Health Authorities\n* Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, contributes to scientific publication of study results\n* Serves as CD liaison/point-of-contact for inquiries from clinical operations, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation\n* Represents CD in sub-teams and addresses CD study or other program-specific questions, develops and provides input for clinical presentation slides and other materials for meetings and ongoing communication\n* Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory research, operations, legal and business development\n* Participates in ongoing enhancements and development of team processes, structures, and tools\n* Develops and mentors study team members\n\n\n\nAbout you: \n* MD, PhD or OD required; PharmD with relevant experience may be considered\n* 5-10 years of clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.)  Gene therapy and/or ophthalmology (retina) experience preferred.\n* Ability to proactively predict issues and solve problems\n* Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team\n* Diplomacy and positive influencing abilities\n* Committed to developing and mentoring team \n* Therapeutic area knowledge relevant to mechanism of action and retinal drug development\n* Understanding of US and Global Regulatory requirements\n\n\n\n\n$225,000 - $275,000 a yearThe salary range for this position is $225,000 USD to $275,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data.  Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan.  Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.\n\nAbout Us\nAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.\n\n\nAt Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Legal jobs that are similar:\n\n $60,000 — $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\nRedwood City, CA

\n \n\nOrganization Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\nThis exciting, newly created role in Procurement will be responsible for leading the category management, sourcing, negotiations, and supplier management for all outsourced services related to the company’s clinical development pipeline and operations, while working cross functionally with internal stakeholders to ensure effective sourcing strategy, selection, contract negotiations, spend management, and resolution of supplier related issues. This leadership role requires keen business facing skillsets and acumen, as well as significant experience interfacing with, and managing, CROs and ancillary vendors across clinical development areas (e.g., Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Central Lab, TMF, etc.). Driving cross-functional collaboration with Immunovant’s leadership, this role will lead procurement initiatives, requests for proposals, supplier selection, contract negotiations, and ongoing business oversight for new and existing vendors.\n\n \nKey Roles and Responsibilities:\n\nBusiness Partnership:\n\n\n* Interface with and facilitate (as needed) across Immunovant’s functional areas to develop requirements and provide guidance/training to Business Owners (BOs) and stakeholders on the end-to-end sourcing process.\n\n* Partner early in cross-functional (Development, Legal, Finance, Program Management, etc.) business planning by effectively fostering relationships internally to maximize timely Procurement support for clinical programs, initiatives, and outcomes.\n\n* Establish clear external outcomes, deliverables/milestones, and payment structures within outsourced services and partners to effectively support the clinical programs and functions.\n\n* Ensure applicable vendors execute services as committed, and support issue resolution for clinical outsourced\n\n* Contribute and support the planning of clinical programs, supplier budgets, timelines, risk management, and financial implications for new or current programs.\n\n\n\n\n \n\nSourcing Process & Supplier Management Leadership:\n\n\n* Develop and execute sourcing strategies for outsourced services in the clinical pipeline.\n\n* Facilitate vendor selection across clinical development and operations teams (e.g. CROs and ancillary vendors).\n\n* Engage with BOs, stakeholders, vendors, and legal team to facilitate review of CDAs, CTAs, MSAs, Consulting Agreements, SOWs, Amendments/Change Orders, and other documents as required.\n\n* Lead the RFx and vendor bidding process for outsourced services, including RFP development, bid comparison analysis, bid defense meetings, and vendor scorecards, as well as manage any changes to existing programs (change orders, scope, etc.).\n\n* Manage the contracting process end-to-end working with key BOs, Legal, and Finance by optimal facilitation, review, and negotiations for outsourced services leveraging appropriate tools and guidance to support the functional areas.\n\n* Manage communication with outsourced vendors with respect to new and/or ongoing procurement support for programs, trials, etc.\n\n* Utilize expertise in total cost of ownership to facilitate and provide stellar negotiations leadership while focusing on “win-win” solutions between Immunovant and outsourced partners.\n\n* Manage supplier enablement/onboarding and purchase orders in system of record.\n\n* Support or lead (as needed) supplier relationship management needs, including metrics/KPI development, scorecards, etc. for business review meetings with key partners.\n\n\n\n\n \n\nProcurement Operational Excellence:\n\n\n* Foster clear, consistent, and open collaboration internally and externally.\n\n* Identify and pursue continuous improvement and constructive change to support higher levels of procurement execution, including development of best practices and timely communication of key learnings.\n\n* Support the issue escalation process at the operational level and ensure timely escalation to senior\n\n* Collaborate with BOs, Legal, and Finance to drive the development of key document templates, training / awareness, negotiation / escalation parameters, processes, systems & tools to support Procurement growth and the clinical pipeline.\n\n* Collaborate with the Clinical and Quality organizations on developing updated procedures on selection, onboarding, and maintenance of outsourced partners.\n\n\n\n\n \nRequirements:\n\n\n* Bachelor’s or Master’s degree with an emphasis on biotech/pharma, life sciences, outsourcing, supplier management, or business partnering.\n\n* 10+ years’ experience in the pharmaceutical/biotech/CRO industry preferred, with a minimum of seven (7) years of direct end-to-end clinical outsourcing\n\n* Must have experience in the procure-to-pay (P2P) process and working in a P2P system. Coupa experience is a plus.\n\n* Excellent interpersonal skills and demonstrated ability to be independently business facing and influence across all levels.\n\n* Ability to build consensus and strong partnerships internally and externally. Must be highly team oriented and comfortable working with cross-functional teams.\n\n* Excellent analytical skills and effective written and verbal communication skills.\n\n* Experience working on clinical trials and working knowledge of GCP preferred.\n\n* Knowledge in clinical budgeting/forecasting and eRFx systems a plus.\n\n* People management experience highly desirable.\n\n* Demonstrated ability to drive oversight, performance and relationship management with CROs and other clinical service providers.\n\n* Highly skilled in establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and focus on delivery and commitments.\n\n* Excellent leadership and influencing skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.\n\n* Flexibility to adapt to the dynamic needs of a rapidly growing biotech company.\n\n* Strong understanding of the drug development lifecycle.\n\n\n\n\n \nWork Environment\n\n\n* Immunovant’s headquarters is located in New York, New York. This position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment.\n\n* Domestic or international travel may be required (<10%).\n\n\n\n\n \n\n \n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Consulting, Travel, Finance and Legal jobs that are similar:\n\n $70,000 — $165,000/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 \nCompany Description:\n\nImmunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compounds, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Both are optimized as a subcutaneous injection with potential flexibility in dosing and approach and are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.\n\n \n\nDue to our growth, we are seeking an Associate General Counsel to join the Immunovant legal department, occupying a position of significant responsibility and reporting directly to Immunovant’s Chief Legal Officer. This individual will work cross-functionally and throughout the organization to provide a broad array of legal and compliance support. The attorney will support Immunovant’s development programs and its multiple clinical trials, SEC filings, and provide counsel and guidance on privacy, business development/alliance management and strategic transactions. High-quality performance in this role will contribute meaningfully to Immunovant’s overall success.\n\n \nKey Responsibilities:\n\n\n* Provide high quality legal advice and serve as a trusted strategic partner to a variety of internal teams\n\n* Coordinate transactional workflows to ensure consistent and efficient delivery of legal support\n\n* Draft and negotiate a broad range of agreements with a particular emphasis on clinical development agreements and related matters\n\n* Serve as a generalist on complex legal and compliance matters for Immunovant, adding legal and business value across all functional areas\n\n* Maintain frequent contact with all functions within the company while managing requests and prioritizing projects\n\n* Develop and present materials on relevant legal and business issues\n\n* Support business development, securities offerings, and other transactions\n\n\n\n\n \nRequirements:\n\n\n* Juris Doctor degree from an ABA-accredited law school and admission to at least one state bar\n\n* 10+ years of relevant experience including biotech/biopharma/pharma experience in an in-house setting and 15+ years of overall legal experience\n\n* Significant transactional experience and exemplary drafting and negotiating skills on a wide range of agreements\n\n* Excellent judgement and ability to asses risks and benefits and convey them in a clear and concise manner\n\n* Strong work ethic and ability to work independently, yet collaboratively, at all levels of the organization with minimal supervision\n\n* Self-motivated, self-starter, and independent\n\n* Excellent productivity, organizational, and time management abilities\n\n* Demonstrated ability to quickly grasp scientific and technical concepts\n\n* Agility and flexibility to handle multiple tasks in a fast-paced, dynamic, biotech environment\n\n* Effectively handle all job office equipment and software (including computer, Microsoft Office, SharePoint, and Slack)\n\n* Outstanding attention to detail and ability to react and respond quickly and effectively\n\n* Ability to exercise initiative and sound judgment and identify opportunities for improvement\n\n* Excellent written and verbal communication skills\n\n* Strong interpersonal skills\n\n* Creative problem solver and ability to think “out of the box”\n\n\n\n\n \nWork Environment:\n\n\n* The position is remote (work from home)\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Travel as required (<5%)\n\n\n\n\n \n\nCompensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $280,000.00 - $300,000.00.\n\n \n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to React, Microsoft, Senior and Legal 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

\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior Director, Commercial Supply Chain and Manufacturing to join its team in the East Coast of the United States or Europe.\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, is a first-in-class small molecule, holding Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a forward-thinking supply chain hands-on leader to join our team as Senior Director, Commercial Supply Chain and Manufacturing. This position will establish end-to-end global commercial supply chain strategy and serve as an internal SME for matters related to commercial manufacturing, demand planning and global logistics including packaging, shipping, and serialization validation. The ideal candidate will bring in-depth expertise in clinical and commercial supply chain management, launch readiness, DP manufacturing, packaging and labeling, serialization, supply planning, supplier (CDMO) relationship management, contract negotiation, sales and operations planning (S&OP), inventory management, third-party logistics (3PL), process improvement, and strategic planning. A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \nThe position will report to the Head of Chemistry, Manufacturing, and Controls (CMC).\n\n\n\nRoles and Responsibilities:\n* Establish the end-to-end global commercial supply chain strategy for Prilenia’s lead product in preparation of launching first approved product. \n* Lead packaging, shipping, and serialization validation in preparation for launch. \n* Provide direction and leadership of Prilenia’s CDMOs and other external partners to ensure on-time delivery of products that comply with regulatory, legal and quality standards. \n* Serve as internal SME for matters related to commercial manufacturing, demand planning and global logistics. \n* Management of 3PL operations, including distribution and inventory management. \n* Lead and oversee commercial drug product manufacturing plans.  \n* Review manufacturing related documentation: production record, protocols, reports. \n* Ensure on-time production and distribution across Drug Substance, Drug Product, Packaging and Labeling. \n* Develop strategies to ensure that commercial supply chain is robust and create risk mitigation plans to ensure that manufacturing timelines are consistent with the company program Responsible for establishing and monitoring manufacturing and demand planning key performance indicators (KPIs). \n* Develop and implement short- and long-term procurement planning strategies toward ensuring 100% availability of raw materials to manufacturing. \n* Manage clinical supply chain in collaboration with relevant internal teams and external vendors (e.g. CROs). \n\n\n\nQualifications:\n* M.Sc. or BA in science and/or engineering (chemistry, pharmacy, engineering or related sciences). \n* 10+ years of extensive experience and demonstrated leadership in clinical and commercial Supply Chain Management and manufacturing. \n* 5+ years’ management experience in a GMP environment with oral solid small molecule products. \n* Ability to manage 3PL provider/s.  \n* Experience in EU supply chain and first launch highly preferred.  \n\n\n\nSkills:\n* A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \n* Capability to build cross-functional alignment including Quality, Regulatory, Finance, Commercial and Manufacturing partners. \n* Excellent oral, written and interpersonal communications skills to effectively interact, exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. \n* Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. \n* Team player with a positive attitude and solid leadership skills who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. \n* Ability to take initiative, be accountable for individual and team results, and motivate self and others to set and achieve very high-performance standards. \n* Must be able to work under pressure, manage time, set priorities and meet deadlines. \n* Experience working effectively in global virtual setting – a must. \n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in the East Coast of the United States (preference for Boston area) or Europe (preference for the Netherlands); occasional in-person/face-to-face meetings will occur.\n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior, Legal, Sales 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