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Senior Medical Director Clinical Development Neuroscience

Arvinas
6 months ago
Remote friendly (New Haven, CT)
United States
Clinical Research and Development
Position Summary
Senior Medical Director (Neurological diseases) reporting to the Executive Medical Director of Clinical Research, Neuroscience.

Principal Responsibilities (Key)
- Partner with discovery/biology leadership to provide clinical input and guidance for the neuroscience corporate strategy.
- Design Phase I/II/III research trials targeting neurologic diseases (CNS/Neurology).
- Monitor patient safety in clinical studies.
- Provide medical/scientific input reviewing clinical data, patient safety data, and laboratory values; maintain ongoing assessment of safety and efficacy.
- Work with internal functions and external partners to manage trial execution and investigator engagement.
- Collaborate on global regulatory plans; participate in regulatory meetings with Regulatory Affairs.
- Develop relationships with external experts to understand drug effects and strengthen the program.
- Provide clinical assessments of potential in-licensing assets and study design/execution challenges.
- Interpret and summarize clinical trial data; lead preparation of study reports, integrated summaries, and clinical sections of package inserts/labeling.
- Provide input on/review reports, applications, and publications.

Additional Responsibilities
- Participate in selecting clinical investigators and guide study investigators.
- Provide medical support to Clinical Operations overseeing CROs.
- Contribute to overall drug development strategy.
- Support IND/CTA/NDA document preparation and safety reports; support global regulatory agency interactions.
- Plan/write/review Clinical Study Reports, regulatory updates, and submissions.
- Analyze/interpret study data for abstracts/publications as required.
- Support due diligence for scientific opportunities (clinical/translational data assessment).
- Provide medical expertise for corporate partnering/business development (partnering committees/task groups).
- Support senior leadership and cross-functional teams for program identification/evaluation/in-licensing.
- Assist with budgets/timelines for the clinical development team.
- Ensure clinical trial medical activities are conducted per Good Clinical Practice.

Qualifications / Required Skills
- 5+ years (7+ strongly preferred) biotech/pharma experience in neurological disease clinical drug development.
- Experience across multiple clinical development stages (IND to NDA/BLA).
- Global clinical development experience (global filing preferred).
- Technical (medical/scientific) experience evaluating targets/agents for in-licensing or internal development.
- Excellent interpersonal and public speaking skills.
- Demonstrated ability to work in a matrix environment with cross-functional teams.
- Legally authorized to work in the U.S. without employer sponsorship.

Highly Desirable
- Experience supervising physicians and/or scientific staff (management/team lead).
- Formal training in Neurology and professional board certification.

Education
- M.D. or equivalent degree required.

Work Location
- New Haven, CT (HQ) or hybrid/remote within the U.S.