Generate:Biomedicines is seeking an experienced and strategic cross-functional team leader accountable for designing and delivering our late-stage respiratory programs, including asthma and COPD.
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
- Knowledge of global regulatory requirements (e.g., FDA, EMA) preferred
- Recent successful BLA submission preferred
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
Other
- Reporting directly to the Chief Medical Officer, this is a senior level business leader
- Strong analytical, communication, and cross-functional leadership skills
- Proven ability to influence internal and external stakeholders, including investigators and health authorities
- Hold teams to high standards for technical and collaborative performance
- Build and develop a diverse, high-performing, and inclusive team culture
