Director, Quantitative Pharmacology and Pharmacometrics – Oncology

Primary Responsibilities
- Serve as an expert representative for QP2-IO on Oncology development teams.
- Frame critical questions and strategy to optimize model-based analyses.
- Develop and execute model-based analyses: translational PK/PD, population PK, exposure-response, clinical trial design simulation, disease progression models, QSP modeling, comparator modeling.
- Strategize and execute modeling of tumor size and survival.
- Maintain knowledge of global regulatory expectations in Oncology; author regulatory documents (INDs, CSRs, CTDs) and represent QP2-IO at regulatory meetings.
- Mentor and/or supervise junior staff.

Minimum Education
- Ph.D. with 7+ years drug development experience in PK/PD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.
- Or Masters or PharmD with 9+ years experience with increasing responsibility and independence.

Required Experience/Qualifications
- Demonstrated impact using pharmacometrics methods.
- Experience with IND/NDA and other global regulatory submissions.
- Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
- Track record of increasing responsibility and driving decisions using model-based approaches.
- Proficiency in R, NONMEM, MATLAB, Monolix or other modeling software.
- Proficiency in written and verbal communication.

Required Skills
Clinical pharmacology; communication; data modeling/visualization; drug development; modeling software; pharmacology; pharmacometrics; program leadership; stakeholder relationship management.

Preferred Skills
- ADCs; biologics; oncology; small molecule drugs; T cells.

Application
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub). Use the posting deadline shown on the listing; Requisition ID: R398667.