- South San Francisco, California, United States
- $345K–$425K per year
- 12+ years
Senior medical leader driving program strategy and clinical development of TV-mediated therapeutics for neurodegenerative diseases and inherited metabolic disorders.
Compensation
Salary Range: $345,000.00 to $425,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.
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. or M.D./Ph.D. with formal training in the areas of neurology, neuroscience, genetics, immunology, and/or rare disease
- Nice to have: leadership in clinical development programs
- Nice to have: FDA approval via accelerated pathways
- Nice to have: orphan drug designation familiarity