Clinical Pharmacology Lead (Associate Director)
Core
Lead clinical pharmacology and Model-Informed Drug Development (MIDD) for Internal Medicine drug portfolios to optimize study designs, dosing, and regulatory submissions.
Role type
Associate Director, Clinical Pharmacology Lead (MIDD)
Builds
End-to-End clinical development plans, PK/PD models, and regulatory documentation for new drug candidates.
Domain
Pharmaceutical R&D, Clinical Pharmacology, Pharmacometrics
Deliverable
production ML models | product features
Required skills
Clinical pharmacology leadership, mechanistic PK/PD modeling, population modeling, clinical trial simulations, NONMEM, R, regulatory document authoring, dose optimization, study design
Preferred skills
Systems pharmacology, literature meta-analyses, external scientific collaboration, coaching
Technologies
NONMEM, R
Responsibilities
Design and execute clinical pharmacology plans; oversee PK/PD analyses and biomarker strategies; author protocols and regulatory documents; optimize dosing regimens; coach team members; present at scientific societies
Seniority
Senior, hands-on IC with leadership responsibilities
