Senior DMPK Scientist-Pharmacokinetics & Regulatory Strategy

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck is seeking a Distinguished Scientist to lead Drug Metabolism and Pharmacokinetics (DMPK) submission activities in support of late-stage programs and global filings. The role involves strategic oversight, collaboration with PDMB and cross-functional partners, and guidance on regulatory strategy and labeling.

The candidate will influence portfolio decisions, contribute to regulatory filings, and help develop future leaders within the DMPK leadership team.

Qualifications

• 15+ years in DMPK with leadership roles in drug discovery and development.
• Strong understanding of regulatory guidelines and clinical development pathways.
• Experience mentoring teams and guiding regulatory submissions.
• Ability to influence portfolio decisions and strategic direction.
• Proven track record in PK/ADME data interpretation for regulatory filings.

Responsibilities

• Monitor late-stage programs and ensure nonclinical PK packages support filings.
• Represent PDMB in label strategy teams and regulatory discussions.
• Review investigator brochures, INDs, NDAs, and regulatory responses.
• Provide scientific oversight across programs to align regulatory strategy.
• Contribute to Clinical Pharmacology strategy and interpretation of Ph1 studies.
• Maintain data/documentation quality in line with regulatory expectations.
• Lead cross-departmental initiatives aligning with portfolio strategy.

Skills

Drug Metabolism

Pharmacokinetics

Regulatory Submissions

Scientific Leadership

Cross-functional Leadership

Regulatory Strategy

Small Molecules

Education

PhD or M.Sci. in Pharmaceutical Sciences, Pharmacology or related field

Job description

Merck is seeking a Distinguished Scientist to lead Drug Metabolism and Pharmacokinetics (DMPK) submission activities in support of late-stage programs and global filings. The role involves strategic oversight, collaboration with PDMB and cross-functional partners, and guidance on regulatory strategy and labeling.

The candidate will influence portfolio decisions, contribute to regulatory filings, and help develop future leaders within the DMPK leadership team.