As Senior Director, Clinical Pharmacology, you will shape and drive the scientific strategy behind the company’s clinical development programs. You will be responsible for designing and executing comprehensive clinical pharmacology plans that span from pre-IND stages through late-phase development, ensuring data-driven decisions at every milestone.
Key Responsibilities
- Develop and implement clinical pharmacology strategies, including pharmacokinetic (PK), pharmacokinetic/pharmacodynamic (PK/PD), and exposure-response modeling, to support optimal dosing and trial design
- Guide dose selection and regimen recommendations using integrated analysis of preclinical and clinical data
- Design and interpret first-in-human studies, including single and multiple ascending dose trials, human mass balance (hAME), and drug-drug interaction (DDI) assessments
- Collaborate with regulatory teams to shape submissions and align clinical pharmacology plans with agency expectations
- Act as a scientific leader across functions, providing expert input to clinical, nonclinical, and regulatory teams
- Translate complex pharmacology data into actionable insights for program teams and senior leadership
- Oversee external vendors and consultants to ensure high-quality, timely delivery of study results and analyses
Work Environment
This position offers a hybrid work model based in San Diego, CA, or fully remote for candidates located on the West Coast of the United States. Candidates based in San Diego or Seattle are preferred. You will operate with significant autonomy while contributing to a collaborative, science-driven organization focused on advancing novel therapeutics.
