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MSD

Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

MSD

. Serve as an expert representative for QP2-IO on Oncology clinical development teams .

Posted 9/15/2026full-timeRahway • New Jersey • United StatesSenior💰 $156,900 - $247,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in model-based analyses and pharmacometrics, with a strong understanding of regulatory expectations in Oncology. Proven ability to collaborate across teams and author regulatory documents to support drug development.

Highest-signal resume keywords
Ph.D. In BiopharmaceuticsPharmacometrics MethodsModel-Based AnalysesR ProgrammingRegulatory Document Authoring

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Translational PK/PD ApproachesPopulation Pharmacokinetic ModelsExposure-Response ModelsClinical Trial SimulationDisease Progression ModelsQSP ModelingComparator ModelingProportional Hazards ModelsExperimental DesignStatistical Analysis
Soft Skills
Critical Data AnalysisMathematical Problem SolvingWritten CommunicationVerbal Communication
Tools & Technologies
NONMEMR
Industry Keywords
OncologyGlobal Regulatory ExpectationsINDsCSRsCTAsCTDs

About the role

Key responsibilities & impact
  • Serve as an expert representative for QP2-IO on Oncology clinical development teams
  • Frame critical questions for optimizing model-based analyses on programs
  • Develop and execute model-based analyses, including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, QSP modeling, and comparator modeling
  • Strategize and execute modeling of tumor size and survival endpoints, including proportional hazards models
  • Maintain comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology
  • Author regulatory documents, including INDs, CSRs, and CTAs/CTDs
  • Represent QP2-IO at regulatory meetings
  • Collaborate with QP2-IO, cross-functional teams, external vendors, and partners to support drug development strategies and decisions

Requirements

What you’ll need
  • Ph.D. in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, systems biology, microbiology, immunology, chemical/biomedical engineering, or a related field with at least 3 years of experience; OR PharmD or MS in a related field or equivalent degree with preferably 5–7 years of relevant experience
  • Demonstrated impactful experience with applications of pharmacometrics methods
  • Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
  • Proficiency in R, NONMEM, or another similar programming language
  • Professional working proficiency in written and verbal communication
  • US and Puerto Rico residents only
  • Visa sponsorship available

Benefits

Comp & perks
  • Annual bonus
  • Long-term incentive, if applicable
  • Medical, dental, and vision healthcare
  • Other insurance benefits for employee and family
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate and sick days
  • Visa sponsorship
  • Domestic relocation