Position Summary
- Senior Medical Director for neuromuscular and neurodegenerative diseases; lead and participate in global clinical research and development programs, including pivotal trials and filing.
Principal Responsibilities (Key)
- Partner with discovery/biology leadership; provide clinical input to develop neuroscience strategy.
- Design Phase I/II/III CNS/Neurology trials.
- Monitor patient safety in clinical studies.
- Review clinical data, safety data, and laboratory values; assess safety and efficacy.
- Manage trial execution and investigator engagement with internal and external partners.
- Collaborate on global regulatory plans; participate in regulatory meetings with Regulatory Affairs.
- Build relationships with external experts to strengthen programs.
- Assess in-licensing assets (study design/execution challenges and opportunities).
- Lead interpretation and summary of clinical trial data (study reports, integrated summaries, clinical portions of package inserts/labeling).
- Provide input/review of reports, applications, and publications.
- Ensure ethical practices and compliance with internal SOPs, local regulations, and laws.
Additional Responsibilities
- Select and guide clinical investigators; support Clinical Operations/ CRO oversight.
- Contribute to overall drug development strategy.
- Support IND/CTA/NDA document and safety report preparation/submission; support global regulatory interactions.
- Plan/write/review Clinical Study Reports and submissions; analyze/interprete data for abstracts/publications.
- Support due diligence, partnering/business development, cross-functional strategy, and clinical budgets/timelines.
- Ensure clinical trial medical activities comply with Good Clinical Practice.
Qualifications
- 5+ years (7+ preferred) biotech/pharma experience in neurological disease clinical drug development.
- Experience across IND to NDA/BLA; global clinical development required; global filing preferred.
- Experience evaluating targets/agents for in-licensing or internal development.
- Supervisory experience desired.
- Excellent interpersonal and public speaking skills; matrix/cross-functional experience.
- Must be legally authorized to work in the U.S. without future sponsorship.
- Duties generally home-office; ability to use computer and communicate during standard business hours.
Education
- M.D. (or equivalent) required; Neurology training and board certification highly preferred.
Benefits
- Competitive base/incentive compensation and comprehensive benefits including group medical, vision, dental, group/supplemental life insurance, and more.