Position Summary
Executive leader responsible for Clinical Pharmacology strategy and integration across all development programs; scope may include broader pharmacology (e.g., nonclinical pharmacology) depending on experience.
Responsibilities
- Lead design and execution of a clinical pharmacology development plan for all assets
- Set clinical pharmacology strategy aligned with corporate and regulatory objectives
- Develop resource plans (employees/vendors) to enable clinical pharmacology development
- Build and lead the Clinical Pharmacology function (talent strategy/capability development)
- Lead and scale a high-performing team
- Lead/influence cross-functional teams to achieve clinical pharmacology goals
- Contribute to development governance and decision-making
- Monitor guidance, regulations, and publications in clinical pharmacology and therapeutic areas
- Provide input to clinical safety programs (e.g., informed consent, exclusion criteria, pregnancy) and clinical pharmacology programs (ADME, DDIs, PK/PD, BE, etc.)
- Identify/work with expert consultants as needed
- Ensure completion of IND/NDA/MAA and other regulatory document sections and robust responses to information requests
- Represent the company with regulatory agencies (queries, pre-meeting documents, Health Authority meetings)
- Lead due diligence for drug in-licensing/partner opportunities
- Potential expansion to leadership of nonclinical pharmacology
Qualifications
- Advanced science degree (e.g., PhD, PharmD)
- 10+ years leadership experience and 15+ years drug development experience
Skills/Abilities
- Communicate scientific information effectively
- Deep understanding of nonclinical/clinical pharmacology requirements and regulatory guidance (US/EU)
- Strong knowledge of pharmacodynamics/pharmacokinetics and modeling
- Experience coordinating studies through CROs
- Experience authoring/supporting regulatory filings (INDs, NDAs, MAAs, DSURs, IBs, etc.)
Compensation
- Salary range: $320,000 to $350,000 USD