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regulatory affairs neurology clinical development nda trial design📋 Description
- Lead clinical development programs in neuromuscular and neurodegenerative diseases.
- Physician with global development and regulatory filing experience.
- Provide leadership to an innovative drug development team.
- Oversee clinical R&D programs, including pivotal trials and filings.
- Liaise with investigators, opinion leaders, and regulators.
- Location: New Haven, CT or hybrid/remote within the U.S.
🎯 Requirements
- 5+ years (7+ preferred) in neuro biotech/pharma clinical development.
- Global clinical development and NDA/BLA filing experience.
- IND to NDA/BLA experience.
- Experience designing Phase I–III CNS/Neurology trials.
- Global regulatory planning and regulatory meetings experience.
- Leadership supervising physicians/scientific staff; cross-functional teamwork.
🎁 Benefits
- Competitive base salary and incentives.
- Medical, vision, and dental coverage.
- Group and supplemental life insurance.
- Career development and employee programs.
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