Site Reliability Engineer improving operational characteristics and collaborating with feature teams for service objectives. Leading automation and reliability initiatives while coaching colleagues.
About the role
- Vice President leading late-stage clinical trials in respiratory diseases at Generate Biomedicines. Pioneering innovations in Generative Biology™ and shaping therapeutic development for asthma and COPD.
Responsibilities
- Leads a high performing Respiratory Product Strategy Team (RPST) comprised of cross-functional leaders accountable for setting the strategy for the late stage respiratory programs
- Direct management and development of medical monitors and clinical scientists
- Develops high quality, ambitious development plans for asthma and COPD programs, aligned with late-stage and corporate objectives and compliant with all relevant regulations
- Recruits, mentors and manages late-state clinicians and scientists
- Collaborates with Head of Safety and PV to define risk-benefit profiles
- Collaborates with Clinical operations and CRO to deliver study to timelines and budget
- Oversees protocol development and clinical/scientific content for regulatory submissions and interactions
- Provides medical leadership and awareness of evolving external landscape for late-stage clinical trials in respiratory diseases (asthma, COPD)
- Drives development and refinement of Target Product Profiles (TPPs), Target Product Claims, and clinical development strategies
- Oversee protocol development, study design, medical review of data, and safety monitoring
- Serve as the primary medical contact for clinical sites, investigators, and regulatory bodies
- Guide interactions with external stakeholders including KOLs, advisory boards, and CROs
- Represent Generate externally at scientific, medical, and regulatory meetings
Requirements
- MD (required), board certification in Pulmonology or Allergy and Immunology Medicine preferred
- 10+ years of clinical development experience in the biopharma industry
- Deep expertise in respiratory diseases (asthma, COPD) and late-stage clinical trials
- Demonstrated success in leading pivotal global studies and regulatory interactions
- Strong analytical, communication, and cross-functional leadership skills
- Proven ability to influence internal and external stakeholders, including investigators and health authorities.
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
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