Generate Biomedicines
Pioneering generative biology to create breakthrough therapeutics.
Senior Director, Clinical Development – Medical Lead, Asthma and COPD
Location
Massachusetts
Posted
16 days ago
Salary
$277K - $416K / year
Postgraduate Degree8 yrs expEnglish
Job Description
• Medical Lead for the Clinical Development Team (CDT) to deliver Phase 3 asthma and COPD studies
• Provide medical leadership and oversight for late-stage clinical trials in asthma and COPD
• Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma and 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)
• Oversee study design, protocol development, data review, and safety monitoring
• 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)
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
• Serve as primary medical contact for clinical sites, investigators, and CROs
• Interpret clinical trial data and contribute to study reports, regulatory filings, and publications
• Represent Generate at internal and external scientific and medical meetings
• Engage with external experts, advisory boards, and health authorities to support program goals
Job Requirements
- MD (required); board certification in Pulmonology or Allergy & Immunology preferred
- 8+ years of clinical development experience in the biopharma industry
- Extensive expertise in asthma and respiratory clinical trial design
- Experience leading late-stage trials and engaging with regulatory bodies
- Strong cross-functional leadership and communication skills
- Proven ability to collaborate with internal teams and external stakeholders.
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package