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MSD

Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

MSD

Senior Director leading quantitative pharmacology and pharmacometrics strategies in oncology. Collaborating across teams to inform drug development decisions and regulatory strategies.

Posted 6/15/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $210,400 - $331,100 per yearWebsite

About the role

Key responsibilities & impact
  • 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

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
  • 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

Benefits

Comp & perks
  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
pharmacokineticspharmacodynamicspharmacometricsmathematicsstatisticsbiostatisticsdrug developmentquantitative strategiesregulatory filingsclinical pharmacology
Soft Skills
leadershipmentoringcollaborationcommunicationproblem solvingteam managementinfluenceorganizational skillsperformance managementresource planning