Summary
Join Generate:Biomedicines as an Executive Director of Clinical Pharmacology and lead the strategy and execution for global Ph2/3 studies. You will act as a subject matter expert for regulatory agency interactions, design and oversee modeling and simulation efforts, and develop global PK, PK/PD, and exposure-response strategies. Collaborate with various teams to optimize clinical trial design and drive pediatric strategy. Build and lead a high-performing clinical pharmacology function, mentor scientists, and champion transparency and adaptability. This role is crucial in bringing pioneering respiratory medicines to patients worldwide and shaping the path for first-in-class medicines.
Requirements
- 12+ years of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions
- Proven track record leading clinical pharmacology deliverables in regulatory agency engagements, including FDA, EMA, PMDA, and NMPA
- Strong background in pediatric development and regulatory submission planning
- Deep expertise in PK/PD modeling and simulation, with demonstrated impact on program strategy
- Excellent written and verbal communication skills, including authoring and defending regulatory documents
- PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field
Responsibilities
- Act as the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans
- Design and oversee modeling and simulation efforts to support decision-making and regulatory submissions
- Lead the development of global PK, PK/PD, exposure-response related strategies, ensuring alignment with expectations in key regions including the US, EU, China, and Japan
- Collaborate closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to optimize clinical trial design and endpoints
- Drive pediatric strategy including iPSP/PSP development and regulatory engagement
- Guide bioanalytical strategy and ensure data integrity across internal and outsourced activities
- Provide clinical pharmacology oversight across development stages
- Build and lead a high-performing clinical pharmacology function with strong cross-functional influence
- Mentor and develop scientists, fostering scientific excellence, accountability, and collaborative innovation
- Champion transparency, adaptability, and urgency to meet program and regulatory milestones
Preferred Qualifications
- Experience supporting respiratory indications preferred
- Prior experience in a fast-growing or first-to-market biotech environment
- Familiarity with combination products or complex biologics
- Working knowledge of bioanalytical methods and data review
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
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