Senior Director, Advanced Pharmacometrics, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (Hybrid or Remote)
Merck
August 08, 2026
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Senior Director, Advanced Pharmacometrics (QP2‑IO)
Primary Responsibilities
- Lead quantitative pharmacology strategy across the oncology portfolio, aligned with program goals.
- Develop and implement long-range plans integrating MIDD, pharmacometrics, data science, and Bayesian modeling to accelerate and de-risk oncology development.
- Partner with Clinical Development, Translational Medicine, Biostatistics, Regulatory, and Data Science to define modeling strategies influencing program design and key decisions.
Scientific & Technical Leadership
- Oversee advanced pharmacometrics modeling: population PK/PD, tumor dynamics and survival modeling; models to inform dose selection, clinical design, and benefit–risk 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).
Team/Collaboration/External Engagement
- Lead, mentor, and develop quantitative scientists in a matrixed environment.
- Collaborate with QP2 leads to design model-informed clinical trials.
- Prepare pharmacometric reports/briefing documents/presentations to support regulatory strategy; represent the company at scientific conferences and external collaborations.
Minimum Education
- Ph.D. (pharmacokinetics/pharmacodynamics, pharmacometrics, math/stats/biostatistics, chemical/biomedical engineering, or related) plus 10+ years pharma drug development (substantial pharmacometrics experience); OR Master’s/PharmD/equivalent plus 15+ years with increasing responsibility and leadership.
Required Skills/Experience
- Extensive MIDD experience in oncology.
- Advanced pharmacometrics expertise: Bayesian hierarchical/joint tumor-survival models, drop-out models, MBMA, clinical trial simulation; integrate PROs/RWD into NLME; hands-on NONMEM, Pumas, Stan, R, and/or Bayesian platforms.
- Advanced analytical skills for trial design/interpretation and decision-making.
- Oncology biology/translation knowledge and clinical endpoints (ORR, PFS, OS).
- Impact across modalities (e.g., ADCs, TCEs, mAbs, cytokines, small molecules).
- Excellent written/verbal communication and ability to influence senior stakeholders in a matrix.
Preferred Skills
- Experience integrating AI/ML into pharmacology/pharmacometrics workflows.
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).
Primary Responsibilities
- Lead quantitative pharmacology strategy across the oncology portfolio, aligned with program goals.
- Develop and implement long-range plans integrating MIDD, pharmacometrics, data science, and Bayesian modeling to accelerate and de-risk oncology development.
- Partner with Clinical Development, Translational Medicine, Biostatistics, Regulatory, and Data Science to define modeling strategies influencing program design and key decisions.
Scientific & Technical Leadership
- Oversee advanced pharmacometrics modeling: population PK/PD, tumor dynamics and survival modeling; models to inform dose selection, clinical design, and benefit–risk 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).
Team/Collaboration/External Engagement
- Lead, mentor, and develop quantitative scientists in a matrixed environment.
- Collaborate with QP2 leads to design model-informed clinical trials.
- Prepare pharmacometric reports/briefing documents/presentations to support regulatory strategy; represent the company at scientific conferences and external collaborations.
Minimum Education
- Ph.D. (pharmacokinetics/pharmacodynamics, pharmacometrics, math/stats/biostatistics, chemical/biomedical engineering, or related) plus 10+ years pharma drug development (substantial pharmacometrics experience); OR Master’s/PharmD/equivalent plus 15+ years with increasing responsibility and leadership.
Required Skills/Experience
- Extensive MIDD experience in oncology.
- Advanced pharmacometrics expertise: Bayesian hierarchical/joint tumor-survival models, drop-out models, MBMA, clinical trial simulation; integrate PROs/RWD into NLME; hands-on NONMEM, Pumas, Stan, R, and/or Bayesian platforms.
- Advanced analytical skills for trial design/interpretation and decision-making.
- Oncology biology/translation knowledge and clinical endpoints (ORR, PFS, OS).
- Impact across modalities (e.g., ADCs, TCEs, mAbs, cytokines, small molecules).
- Excellent written/verbal communication and ability to influence senior stakeholders in a matrix.
Preferred Skills
- Experience integrating AI/ML into pharmacology/pharmacometrics workflows.
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).