Sr Medical Director, Clinical Development

Senior Medical Director, Clinical Development

Location: Bay Area (South San Francisco preferred)

Role Overview

The Senior Medical Director, Clinical Development will serve as a hands-on medical lead for a late-stage biologics program, owning clinical strategy, execution, and regulatory readiness through key FDA milestones. This role is ideal for a physician-leader who stays close to the data, moves quickly, and thrives in a high-accountability environment.

Key Responsibilities

• Lead clinical development strategy and execution for a late-stage program

• Own protocol development, safety oversight, and data interpretation

• Partner closely with Regulatory Affairs on FDA interactions and submissions

• Work day-to-day with Clinical Operations and Biostatistics to drive trial quality and timelines

• Support advisory boards, investigator engagement, and internal decision-making

Qualifications

• MD with 8+ years of Clinical Development experience in biotech or pharma

• Direct experience with late-stage programs and regulatory submissions (BLA/NDA preferred)

• Background in rare disease, neurodegenerative, pediatric, or complex biologics a plus

• Decisive, hands-on leader comfortable operating at speed

Why This Role

• High-impact, execution-focused Clinical Development leadership

• Direct influence on upcoming FDA milestones

• Bay Area-based program with meaningful patient impact