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

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.

Senior Director, Clinical Development – Medical Lead, Asthma and COPD

Key skills