Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

MSD•Rahway, NJ

1d•$210,400 - $331,100•Hybrid

About The Position

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.

Requirements

Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or related discipline with ≥10 years of relevant pharmaceutical industry experience OR Master’s, PharmD, or equivalent degree with ≥15 years of relevant pharmaceutical industry experience, with a demonstrated record of increasing responsibility, independence, and leadership in similar roles.
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, computational biology, or a related field
Oncology therapeutic area or disease knowledge
Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others
Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise
Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)
Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity
Relevant regulatory and quantitative pharmacology experience
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
Clinical Development
Clinical Pharmacology
Cross-Functional Collaboration
Drug Development
Leadership
Oncology
Oncology Drug Development
Pharmacometrics
Regulatory Interactions
Stakeholder Relationship Management
Team Management
Translational Pharmacokinetics and Pharmacodynamics (PKPD)
Verbal Communications

Nice To Haves

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Responsibilities

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 TCEs
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
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
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