Director of Clinical Pharmacology and Quantitative Pharmacology
Core
Lead model-informed drug development to shape dose strategy from first-in-human through registration, partnering with clinicians and regulatory teams to accelerate breakthrough medicines.
Role type
Director of Clinical Pharmacology and Quantitative Pharmacology
Builds
Dose selection strategies, trial designs, and regulatory documentation for early and late-stage clinical programs.
Domain
Biopharmaceuticals / Clinical Development / Pharmacometrics
Deliverable
production ML models | product features
Required skills
Population PK/PD analysis, Exposure-response modeling, PBPK modeling, QSP modeling, Regulatory strategy (IND/IB/IMPD), Team leadership, Drug development process knowledge
Preferred skills
Leadership across multiple programs, Proficiency with NONMEM/Monolix/Phoenix/Simcyp, Experience in rare disease/immunology, Authoring regulatory summaries, Publications in MIDD
Technologies
NONMEM, Monolix, Phoenix, Simcyp
Responsibilities
Represent CPQP on Global Project Team and lead function sub-team, Develop and execute CP/QP plans using MIDD strategies, Lead CP sections of protocols and development plans, Contribute to regulatory packages and articulate MIDD rationale, Provide integrated input across research, toxicology, and commercial stakeholders, Lead and develop a team of scientists
Seniority
Director, strategic leadership with hands-on technical expertise
