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

MSD

. Lead and shape quantitative pharmacology strategy across oncology programs to inform dose selection, trial design, and go/no-go decisions .

Posted 9/15/2026full-timeRahway • New Jersey • United StatesSenior💰 $210,400 - $331,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quantitative pharmacology and drug development, with a strong focus on regulatory strategies and interdisciplinary collaboration. Proven leadership in managing teams and driving high-quality deliverables in oncology programs.

Highest-signal resume keywords

Ph.D. In Pharmacokinetics/PharmacodynamicsQuantitative Pharmacology Strategy DevelopmentRegulatory Strategy InfluenceOncology Drug Development ExpertiseTeam Leadership And Management

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Applicant Tracking System Keywords

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Hard Skills

Clinical DevelopmentClinical PharmacologyPharmacometricsDrug DevelopmentRegulatory ResponsesQuantitative StrategiesPerformance ManagementModel-Informed Drug DevelopmentStatistical AnalysisInterdisciplinary Collaboration

Soft Skills

CommunicationCross-Functional CollaborationProblem SolvingDriving ResultsManaging Ambiguity

Industry Keywords

OncologyPharmaceutical IndustryBiologicsSmall MoleculesADCsTCEsINDsCSRsCTD ModulesNDA/BLA Submissions

About the role

Key responsibilities & impact

Lead and shape quantitative pharmacology strategy across oncology programs to inform dose selection, trial design, and go/no-go decisions
Develop and implement integrated model-informed drug development (MIDD) strategies across development stages
Align modeling strategies with regulatory expectations and business priorities
Maintain understanding of global regulatory expectations for small molecules, biologics, 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 ensure high-quality and timely deliverables
Contribute to QP2 and Oncology leadership initiatives, talent strategies, and organizational priorities
Support resource planning and allocation 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 translate nonclinical findings into clinical development plans
Contribute to due diligence for business development and licensing opportunities
Develop and contribute to regulatory strategies and author or review INDs, CSRs, CTD modules, and NDA/BLA submissions
Ensure high-quality clinical pharmacology and pharmacometric analyses and reports
Represent the company in regulatory agency interactions, scientific conferences, and external collaborations
Report directly to the QP2 Oncology Executive Director

Requirements

What you’ll need

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 and 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 oversee the work of others
Extensive experience developing quantitative strategies for impacting pipeline decisions and drug development expertise
Ability to influence regulatory strategies, including independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)
Experience operating in an inclusive, high-performance work environment while fostering collaboration, driving results, and managing ambiguity
Relevant regulatory and quantitative pharmacology experience
Proficiency in written and verbal communication, interdisciplinary collaboration, problem scoping, and planning
Required skills: Clinical Development, Clinical Pharmacology, Communication, Cross-Functional Collaboration, Drug Development, Leadership, Oncology, Oncology Drug Development, Pharmacometrics, Regulatory Responses, Stakeholder Relationship Management, Team Management
US and Puerto Rico residents only

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare benefits for employee and family
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Flexible work arrangements: Hybrid