Senior Director, Clinical Development – COPD
Generate Biomedicines
Senior Director, Clinical Development, COPD
Generate Biomedicines
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $254,000 - $381,000 per year
Job Level
Senior
About the role
- Lead the Clinical Development Team (CDT) to deliver Phase 3 COPD studies
- Provide medical leadership and oversight for late-stage clinical trials in COPD
- Serve as key author of late-stage clinical protocols aligned with regulatory requirements
- Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
- Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity
- Serve as a member of the Safety Management Team (SMT)
- Guide the development and optimization of COPD-specific clinical strategies and Target Product Profiles (TPPs)
- Lead protocol development, study design, and clinical data review
- Ensure safety monitoring and collaboration with cross-functional partners (PV, Regulatory, Clinical Operations, Biostats)
- Act as the primary medical contact for sites, investigators, and CROs
- Analyze clinical data and contribute to clinical study reports, publications, and regulatory submissions
- Represent Generate at scientific and regulatory meetings and interface with key opinion leaders, advisory boards, and regulatory agencies
- Set high expectations for technical excellence, build and sustain a diverse high-performing team, align functional strategies, communicate transparently, and promote adaptability and smart risk-taking
Requirements
- MD (required)
- Board certification in Pulmonology or Allergy & Immunology preferred
- 8+ years of clinical development experience in biopharma
- Significant expertise in COPD clinical trial design and respiratory therapeutics
- Experience with global late-stage studies and regulatory engagement
- Strong leadership, analytical, and interpersonal communication skills
- Proven ability to manage cross-functional teams and external partnerships
- Advanced clinical or scientific training (e.g., fellowship, MPH) is a plus
- Experience in both biotech and large pharma environments (nice to have)
- Familiarity with global regulatory processes (FDA, EMA) (nice to have)
- Experience with successful late-stage submissions (e.g., BLA, MAA) (nice to have)
