Primary Responsibilities
- Lead quantitative pharmacology strategy across the oncology portfolio; align with program goals and organizational priorities.
- Develop and implement long-range plans integrating MIDD, pharmacometrics, data science, and Bayesian modeling to accelerate and de-risk oncology drug development.
- Partner with Clinical Development, Translational Medicine, Biostatistics, Regulatory, and Data Science to define modeling strategies influencing program design and key decisions.
- Oversee advanced pharmacometrics development (population PK/PD, tumor dynamics and survival modeling; models informing dose selection, clinical design, and benefitโrisk assessments).
- Champion Bayesian methods (hierarchical/joint modeling, prior-data integration).
- Ensure regulatory-grade pharmacometric deliverables for submissions, label negotiations, and scientific advice.
- Promote innovation in modeling tools, computational frameworks, and analytics platforms (including AI/ML).
- Lead, mentor, and develop quantitative scientists; foster scientific rigor, collaboration, and innovation.
- Collaborate to design model-informed, efficient clinical trials and integrate modeling into decision frameworks.
- Support regulatory strategy via pharmacometric reports, briefing documents, and presentations; represent the company at external scientific venues.
Minimum Education
- Ph.D. (pharm/PK/PD/pharmacomet/Math/Stats/Eng or related) + 10 years pharmaceutical drug development (substantial pharmacometrics experience) OR Masterโs/PharmD/equivalent + 15 years with increasing leadership.
Required Experience & Skills
- Deep oncology MIDD experience driving decisions.
- Advanced pharmacometrics (Bayesian hierarchical/joint tumor-survival, drop-out models, MBMA, clinical trial simulation; PROs/RWD in NLME).
- Hands-on NONMEM, Pumas, Stan, R, and/or Bayesian platforms.
- Advanced analytical skills for trial design/interpretation and decision-making.
- Oncology biology, translational pathways, and endpoints (ORR, PFS, OS, tumor dynamics).
- Impact across modalities (ADCs, TCEs, mAbs, cytokines, small molecules).
- Preferred: AI/ML integration into workflows.
- Excellent written/verbal communication and senior-level stakeholder influence.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.