Senior DMPK Scientist: PK/Metabolism & Regulatory Submissions

Merck & Co.; West Point (PA); Hybrid; USD 210,000 - 331,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck & Co. is seeking a Distinguished Scientist in Drug Metabolism and Pharmacokinetics (DMPK) to lead submission-expert activities across diverse programs from familiarization to life-cycle management.

The role influences PDMB strategy, regulatory filings, and labeling discussions while driving cross-functional collaboration and scientific leadership. The candidate will supervise nonclinical PK packages, prepare regulatory submissions, and mentor teams, with a focus on high-quality filings and

Qualifications

• 15+ years of experience in DMPK with leadership in drug discovery and development programs.
• Strong understanding of drug development processes and regulatory guidelines with clinical candidacy support.
• Experience mentoring program teams on nonclinical and clinical issues.
• Proven ability to influence strategy across disciplines and regulatory expectations.
• Excellent written and verbal communication for regulatory documents and leadership discussions.
• Experience navigating preclinical through post-approval stages across modalities.

Responsibilities

• Oversee nonclinical PK packages and regulatory submissions to support filings (OMA/sNDA).
• Represent PDMB in Label Approval Strategy Teams and regulatory discussions.
• Review regulatory documents supporting global trials and registrations.
• Provide strategic oversight for development candidates across therapeutic areas.
• Lead cross-functional initiatives to align regulatory strategy with portfolio goals.
• Contribute to clinical pharmacology strategy and mechanistic investigations.
• Drive data/doc quality in response to regulatory expectations across regions.
• Develop future leaders and build organizational expertise in regulatory guidelines.

Skills

Drug Development

Drug Metabolism

Pharmacokinetics

Portfolio Strategies

Regulatory Submissions

Regulatory Strategies

Scientific Leadership

Small Molecules

Education

PhD in Pharmaceutical Sciences

Job description

Merck & Co. is seeking a Distinguished Scientist in Drug Metabolism and Pharmacokinetics (DMPK) to lead submission-expert activities across diverse programs from familiarization to life-cycle management.

The role influences PDMB strategy, regulatory filings, and labeling discussions while driving cross-functional collaboration and scientific leadership. The candidate will supervise nonclinical PK packages, prepare regulatory submissions, and mentor teams, with a focus on high-quality filings and