Senior Director, Group Leader - Quantitative Oncology PK/PM

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co. seeks a Senior Director, Group Leader to lead the Quantitative Pharmacology and Pharmacometrics - Oncology (QP2 Oncology) team within Global Clinical Development.

You will drive model-informed drug development strategies, translational PK/PD, and biomarker‑driven dose selection to inform key development and regulatory decisions. You will oversee a team of QP2 scientists, partner with Clinical Development, Translational Medicine, Biostatistics and Regulatory, and help shape portfolio

Qualifications

• 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 NDA/MAA
• Record of ability to operate in an inclusive and high-performance work environment
• Relevant regulatory and quantitative pharmacology experience
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning

Responsibilities

• Lead quantitative pharmacology strategy across oncology programs to inform development 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

Skills

Clinical Development

Clinical Pharmacology

Pharmacometrics

Regulatory Strategy

Leadership

Oncology

Team Management

Cross-Functional Collaboration

Regulatory Submissions

Communication

Drug Development

Stakeholder Relationship Management

Oncology Drug Development

Regulatory Responses

Education

Ph.D. in pharmacokinetics/pharmacodynamics/pharmacometrics/biomedical engineering or related

Master's, PharmD, or equivalent degree with 15+ years of experience

Tools

Regulatory experience

Quantitative modeling

Job description

Merck & Co. seeks a Senior Director, Group Leader to lead the Quantitative Pharmacology and Pharmacometrics - Oncology (QP2 Oncology) team within Global Clinical Development.

You will drive model-informed drug development strategies, translational PK/PD, and biomarker‑driven dose selection to inform key development and regulatory decisions. You will oversee a team of QP2 scientists, partner with Clinical Development, Translational Medicine, Biostatistics and Regulatory, and help shape portfolio