Group Leader, Quantitative Pharmacology & Pharmacometrics

Merck; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Director, Group Leader to lead Quantitative Pharmacology and Pharmacometrics (QP2 Oncology), guiding strategy and modeling across oncology programs from preclinical through registration.

The role drives MIDD, translational PK/PD, biomarker-informed dose selection, regulatory strategy, and cross-functional collaboration with Clinical Development, Translational Medicine, Biostatistics, and Regulatory to inform pivotal decisions.

Qualifications

• Pharmacometrics and quantitative pharmacology expertise required.
• Strong leadership of interdisciplinary teams and cross-functional collaboration expected.
• Experience with regulatory strategy development and NDA/MAA submissions preferred.

Responsibilities

• Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions.
• Develop and implement integrated MIDD strategies to support decision-making across development stages.
• Ensure alignment of modeling strategies with regulatory expectations and business priorities.
• Maintain understanding of global regulatory expectations for small molecules, biologics and new modalities.

Skills

Clinical Development

Clinical Pharmacology

Communication

Cross‑Functional Collaboration

Drug Development

Leadership

Oncology

Oncology Drug Development

Pharmacometrics

Regulatory Responses

Stakeholder Relationship Management

Team Management

Education

Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or related discipline with ≥10 years of relevant pharmaceutical industry experience

Master’s, PharmD, or equivalent degree with ≥15 years of relevant pharmaceutical industry experience

Job description

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Director, Group Leader to lead Quantitative Pharmacology and Pharmacometrics (QP2 Oncology), guiding strategy and modeling across oncology programs from preclinical through registration.

The role drives MIDD, translational PK/PD, biomarker-informed dose selection, regulatory strategy, and cross-functional collaboration with Clinical Development, Translational Medicine, Biostatistics, and Regulatory to inform pivotal decisions.