Senior Director, Advanced Pharmacometrics, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (Hybrid or Remote)
Merck
August 30, 2026
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Primary Responsibilities
Strategic Leadership
- Lead quantitative pharmacology strategy across the oncology portfolio, aligning with program goals.
- 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.
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 and joint modeling; prior-data integration).
- Ensure regulatory-grade pharmacometric deliverables for submissions, label negotiations, and scientific advice meetings.
- Promote innovation in modeling tools (including AI/ML, computational frameworks, and analytics platforms).
Team Leadership & Development
- Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
- Foster scientific rigor, excellence, collaboration, and innovation.
Cross-Functional Collaboration
- Collaborate with QP2 leads to design efficient, model-informed clinical trials.
- Integrate advanced modeling into decision frameworks with Translational and Clinical functions and Biostatistics.
Regulatory & External Engagement
- Support regulatory strategy via pharmacometric reports, briefing documents, and presentations.
- Represent the company at scientific conferences, external collaborations, consortia, and industry working groups.
Minimum Education
- Ph.D. in relevant field with at least 10 years pharma drug development experience (substantial pharmacometrics experience), OR
- Master’s/PharmD/equivalent with at least 15 years experience and demonstrated leadership/increasing responsibility.
Required Experience and Skills
- Extensive MIDD experience in oncology drug development.
- Advanced pharmacometrics expertise: Bayesian hierarchical models, joint tumor/survival modeling, dropout models, MBMA, advanced simulation; integrate PROs and RWD into NLME.
- Hands-on NONMEM, Pumas, Stan, R, and/or Bayesian platforms.
- Advanced analytical skills for clinical trial design/interpretation and decision-making.
- Oncology/translational endpoint knowledge (e.g., ORR, PFS, OS; tumor dynamics).
- Impact across therapeutic modalities (e.g., ADCs, TCEs, mAbs, cytokines, small molecules).
- Strong written/verbal communication and stakeholder management; influence at senior levels.
Preferred Skills
- Experience integrating AI/ML into clinical pharmacology/pharmacometrics workflows.
Application instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).
Strategic Leadership
- Lead quantitative pharmacology strategy across the oncology portfolio, aligning with program goals.
- 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.
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 and joint modeling; prior-data integration).
- Ensure regulatory-grade pharmacometric deliverables for submissions, label negotiations, and scientific advice meetings.
- Promote innovation in modeling tools (including AI/ML, computational frameworks, and analytics platforms).
Team Leadership & Development
- Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
- Foster scientific rigor, excellence, collaboration, and innovation.
Cross-Functional Collaboration
- Collaborate with QP2 leads to design efficient, model-informed clinical trials.
- Integrate advanced modeling into decision frameworks with Translational and Clinical functions and Biostatistics.
Regulatory & External Engagement
- Support regulatory strategy via pharmacometric reports, briefing documents, and presentations.
- Represent the company at scientific conferences, external collaborations, consortia, and industry working groups.
Minimum Education
- Ph.D. in relevant field with at least 10 years pharma drug development experience (substantial pharmacometrics experience), OR
- Master’s/PharmD/equivalent with at least 15 years experience and demonstrated leadership/increasing responsibility.
Required Experience and Skills
- Extensive MIDD experience in oncology drug development.
- Advanced pharmacometrics expertise: Bayesian hierarchical models, joint tumor/survival modeling, dropout models, MBMA, advanced simulation; integrate PROs and RWD into NLME.
- Hands-on NONMEM, Pumas, Stan, R, and/or Bayesian platforms.
- Advanced analytical skills for clinical trial design/interpretation and decision-making.
- Oncology/translational endpoint knowledge (e.g., ORR, PFS, OS; tumor dynamics).
- Impact across therapeutic modalities (e.g., ADCs, TCEs, mAbs, cytokines, small molecules).
- Strong written/verbal communication and stakeholder management; influence at senior levels.
Preferred Skills
- Experience integrating AI/ML into clinical pharmacology/pharmacometrics workflows.
Application instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).