Senior Director, Pharmacometrics
Core
Lead model-informed drug development strategies for targeted oncology therapeutics, supporting clinical development decisions, dose selection, and regulatory submissions.
Role type
Senior Director, Pharmacometrics (Strategy & Leadership)
Builds
Clinical development plans, regulatory submissions (IND/NDA/BLA), and quantitative evidence packages for oncology drugs.
Domain
Biopharmaceuticals / Oncology / Pharmacometrics
Deliverable
production ML models | dashboards & analysis
Required skills
Population PK, PK/PD, exposure-response modeling, PBPK, QSP, simulation, regulatory submission support, vendor management, team leadership
Preferred skills
ADC development, biologics, targeted radiotherapies, small molecules
Technologies
NONMEM, Monolix, Phoenix, R, SAS, Python, MATLAB, Simcyp, GastroPlus
Responsibilities
Develop pharmacometrics strategies aligned with clinical objectives; lead dose selection and optimization; oversee model development and regulatory documentation; manage external vendors and CROs; mentor quantitative scientists.
Seniority
Senior Director, strategic leadership with hands-on technical oversight