- South San Francisco, California, United States
- Full-time · Executive
- $345K–$425K per year
- 12+ years
The Executive Medical Director will serve as a senior medical leader driving program strategy and clinical development of TV-mediated therapeutics aimed at treating neurodegenerative diseases and inherited metabolic disorders.
Compensation
Salary Range: $345,000.00 to $425,000.00
Responsibilities
- Provides medical oversight of clinical trial design, ensuring scientific rigor, endpoint defensibility, and alignment with regulatory expectations
- Establishes clinical development standards, frameworks, and best practices across programs.
- Provide expertise and contribute as needed to advisory board planning and execution, steering committee meetings, and data safety management committees
- Leads preparation and discussions for Type A/B/C health authority interactions, NDA/BLA or MAA submissions, and labeling negotiations
- Leads medical input on proposed indications, contraindications, warnings, dosing language, and patient population definitions
Requirements
- M.D.
- M.D./Ph.D.
- Nice to have: leadership role in clinical development programs
- Nice to have: achieving FDA approval via accelerated pathways
- Nice to have: Orphan Drug