Director, Quantitative Oncology Pharmacometrics

Merck; North Wales (Montgomery County); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical

Dental

Vision insurance

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck seeks an experienced Director to join the Quantitative Pharmacology and Pharmacometrics team (QP2-IO) leading model-based analyses in Oncology drug development. The role blends PK/PD, population PK, QSP, and regulatory science across development programs, with cross-functional collaboration and external partnership.

You will guide translational modeling, design simulations, and tumor size/survival analyses while mentoring junior scientists and ensuring compliance with regulatory standards.

Qualifications

• Ph.D. with at least seven years of pharmaceutical drug development experience relating to PK/PD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
• Masters or PharmD with at least nine years of experience in a similar role in pharmaceutical drug development.

Responsibilities

• Serving as an expert representative for QP2-IO on Oncology development teams.
• Framing critical questions and strategy for optimizing model-based analyses on programs.
• Developing and executing model-based analyses including translational PK/PD, population PK, exposure–response, clinical trial design simulation, disease progression, QSP modeling, and comparator modeling.
• Strategizing and executing modeling of tumor size and survival.
• Maintaining understanding of global regulatory expectations for Oncology; authoring INDs, CSRs, CTDs, and representing QP2-IO at regulatory meetings.
• Mentoring and/or supervising junior staff to perform these duties.

Skills

Clinical Pharmacology

Communication

Data Modeling

Data Visualization

Drug Development

Modeling Software

Pharmacology

Pharmacometrics

Program Leadership

Stakeholder Relationship Management

Education

Ph.D. in relevant field

Masters or PharmD with substantial experience

Tools

R

NONMEM

MATLAB

Monolix

Job description

Merck seeks an experienced Director to join the Quantitative Pharmacology and Pharmacometrics team (QP2-IO) leading model-based analyses in Oncology drug development. The role blends PK/PD, population PK, QSP, and regulatory science across development programs, with cross-functional collaboration and external partnership.

You will guide translational modeling, design simulations, and tumor size/survival analyses while mentoring junior scientists and ensuring compliance with regulatory standards.