Executive Director, Clinical Pharmacology

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. Guide bioanalytical strategy and provide clinical pharmacology oversight across development stages. Build and lead a high-performing team, mentor scientists, and champion transparency and adaptability. This role requires 12+ years of experience in clinical pharmacology within biotech or pharma, a proven track record in regulatory agency engagements, and deep expertise in PK/PD modeling and simulation. A PhD, PharmD, or MD in a related field is required. Generate:Biomedicines offers a competitive salary, annual bonus, equity compensation, and a comprehensive benefits package.

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

• 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