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.