Senior DMPK Scientist: PK & Regulatory Strategy

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

Job summary

Merck is seeking a Distinguished Scientist in the DMPK domain to lead drug metabolism and pharmacokinetics submission strategy. You will ensure robust nonclinical PK packages for OMA and sNDA filings while aligning with program objectives and regulatory expectations.

You will influence portfolio decisions, support regulatory filings, and help develop future leaders in a dynamic, cross-functional environment.

Qualifications

• Minimum experience of 15 years in DMPK.
• Experience in supporting drug discovery and development programs.
• Mentoring program team representatives on nonclinical and clinical issues.
• Ability to influence strategic direction across disciplines.
• Excellent written and verbal communication skills.

Responsibilities

• Oversee nonclinical PK packages for filings (OMA/sNDA).
• Represent PDMB in Label Approval Strategy Teams and regulatory discussions.
• Review regulatory documents to support global trials and registrations.
• Provide scientific and strategic oversight across therapeutic areas with cross-functional partners.
• Lead initiatives to improve policies, procedures, and regulatory readiness.

Skills

DMPK leadership

Regulatory strategy

Nonclinical PK

Cross-functional collaboration

Scientific leadership

Education

PhD in Pharmaceutical Sciences

MSci in Pharmaceutical Sciences

Job description

Merck is seeking a Distinguished Scientist in the DMPK domain to lead drug metabolism and pharmacokinetics submission strategy. You will ensure robust nonclinical PK packages for OMA and sNDA filings while aligning with program objectives and regulatory expectations.

You will influence portfolio decisions, support regulatory filings, and help develop future leaders in a dynamic, cross-functional environment.