Executive Director, Clinical Pharmacology

Key Responsibilities

• Provide scientific leadership for clinical pharmacology strategy across programs, with emphasis on PK, ADA, and exposure–response relationships.
• Lead the analysis, interpretation, and integration of PK and ADA data from rodent, non-human primate (NHP), and clinical studies.
• Guide dose selection and optimization strategies using nonclinical–clinical translation and clinical PK/ADA data.
• Interpret non-clinical PK and immunogenicity data to support first-in-human starting dose and escalation strategy.
• Serve as the clinical pharmacology subject-matter expert on clinical study teams.
• Support the design and interpretation of clinical PK/ADA sampling strategies, including timing and assay considerations and assess the impact of immunogenicity (ADA, NAb) on PK, efficacy, and safety across clinical studies.
• Author and review clinical pharmacology-related sections of regulatory documents such as INDs, BLAs, Clinical study reports (CSRs), and Investigator’s brochures.

Qualifications And Experience

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or a related discipline (MD or PharmD with relevant experience will also be considered).
• 12+ years of progressive experience with demonstrated program leadership.
• Strong hands-on experience with clinical and non-clinical PK data interpretation, Immunogenicity (ADA/NAb) assessment and impact analysis, Biologic drug development, ideally in cardiovascular, rare, and/or inflammatory diseases.
• Strategic thinker with strong scientific judgment.
• Effective cross-functional collaborator and communicator.
• Comfortable operating in a fast-paced, matrixed biotech environment.
• Demonstrated ability to mentor, develop, and scientifically guide team members.
• High level of accountability, independence, and integrity.