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Group Leader - Senior Director, Quantitative Pharmacology and Pharmacometrics – Oncology

Job in North Wales, Montgomery County, Pennsylvania, 19454, USA
Listing for: Merck Sharp & Dohme (MSD)
Full Time position
Listed on 2026-10-15
Job specializations:
  • Management
    Regulatory Compliance Specialist
Job Description & How to Apply Below
Location: North Wales

Job Description We are seeking an accomplished scientific leader to join the Quantitative Pharmacology and Pharmacometrics – Oncology (QP2 Oncology) team as Senior Director, Group Leader. QP2 Oncology is part of the Global Clinical Development organization and has oversight of clinical pharmacology, mechanistic PK-PD modeling, and pharmacometrics for oncology programs from post-preclinical candidate (PCC) selection through registration.

Senior Directors are recognized scientific thought leaders who develop and implement clinical pharmacology strategies with a focus of utilizing MIDD strategies to advance drug development. This would include translational PK/PD strategies, biomarker-driven dose selection approaches, pharmacometric modeling and other quantitative approaches (e.g. QSP, AI/ML) for key development and regulatory decisions.

This role provides strategic leadership and scientific oversight across a significant portion of the oncology portfolio. The Senior Director, Group Leader will lead a team of QP2 scientists and serve as a key contributor to oncology program strategy by applying model-informed drug development (MIDD) approaches to support critical decisions.

Reporting directly to the QP2 Oncology Executive Director, the individual will collaborate closely with the QP2 Oncology Leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the oncology portfolio. The role requires strong collaboration with cross-functional partners, including Clinical Development, Translational Medicine, Biostatistics, and Regulatory, as well as alignment with preclinical partners to inform first-in-human and clinical development strategies.

Primary Responsibilities:

Strategic & Scientific Leadership Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions (e.g., dose selection, trial design, go/no-go 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 a comprehensive understanding of global regulatory expectations for small molecules, biologics including new modalities such as ADCs and TCEsTeam Leadership & Organizational Impact Lead, mentor, and develop a team of QP2 scientists, including performance management, hiring, retention, and talent development

Provide scientific and operational oversight to team members, ensuring high-quality and timely deliverables

Contribute to broader QP2 and Oncology leadership initiatives, including talent strategies and organizational priorities

Identify and support resource planning and allocation in partnership with senior leadership

Program & Cross-Functional Leadership Serve as QP2 lead on assigned programs and represent QP2 in cross-functional teams and governance forums

Collaborate with Translational, Clinical, and Biostatistics teams to integrate quantitative insights into development strategies

Partner with preclinical teams to ensure appropriate translation of nonclinical findings into clinical development plans

Contribute to due diligence for business development and licensing opportunities

Regulatory & External Engagement Develop and contribute to regulatory strategies, including authoring and reviewing key documents (e.g., INDs, CSRs, CTD modules, NDA/BLA submissions)
Ensure delivery of high-quality clinical pharmacology and pharmacometric analyses and reports

Represent the company in interactions with regulatory agencies, scientific conferences, and external collaborations

Minimum Education Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics,…
Position Requirements
10+ Years work experience
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