Generate:Biomedicines is seeking an experienced leader to design and deliver late-stage respiratory programs, specifically for asthma and COPD, aiming to create breakthrough medicines through generative biology.
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)
- Recent successful BLA submission preferred
Responsibilities
- Develops high quality, ambitious development plans for asthma and COPD programs, aligned with late-stage and corporate objectives and compliant with all relevant regulations
- Oversees protocol development and clinical/scientific content for regulatory submissions and interactions
- 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
Other
- MD (required)
- Strong analytical, communication, and cross-functional leadership skills
- Proven ability to influence internal and external stakeholders, including investigators and health authorities
- remote (U.S.) optional with travel to HQ based on business needs
- The addition of a cover letter with a high level overview of your direct expertise in leading late stage clinical trials in asthma and/or COPD would be greatly appreciated
