Senior DMPK Scientist, Pharmacokinetics

Merck; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Vacation

Sick days

Hybrid work

Job summary

Merck seeks a Distinguished Scientist in DMPK to lead nonclinical PK submissions and regulatory strategy across portfolios. You will influence labeling decisions, collaborate with global teams, and guide development programs from late-stage discovery through post-approval.

You will contribute to PDMB leadership, mentoring scientists and advancing regulatory science in multiple modalities. This hybrid role is based near Rahway, NJ.

Qualifications

• Minimum 15 years in DMPK with leadership in drug discovery and development.
• Strong understanding of drug development and regulatory guidelines.
• Experience mentoring program teams on nonclinical and clinical issues.
• Proven ability to influence strategic direction across disciplines.
• Excellent written and verbal communication for regulatory documents and presentations.
• Experience authoring nonclinical PK packages and clinical sections of regulatory submissions.

Responsibilities

• Monitor late-stage development programs and ensure robust nonclinical packages aligned with filing strategy.
• Represent PDMB in Label Approval Strategy Teams and regulatory discussions.
• Review regulatory documents to support global trials and registrations.
• Provide scientific oversight for development candidates across therapeutic areas.
• Contribute to Clinical Pharmacology strategy and interpretation of Ph1 studies.
• Ensure DMPK data and documentation meet regulatory expectations.
• Lead cross-departmental initiatives to improve policies and regulatory alignment.
• Oversee due diligence for in-licensing assets and integration as program lead.
• Develop future leaders in drug development and regulatory guidance.

Skills

Drug Development

Drug Metabolism

Pharmacokinetics

Portfolio Strategies

Regulatory Filings

Regulatory Strategies

Regulatory Submissions

Scientific Leadership

Small Molecules

Education

PhD or MSci in Pharmaceutical Sciences

Job description

Merck seeks a Distinguished Scientist in DMPK to lead nonclinical PK submissions and regulatory strategy across portfolios. You will influence labeling decisions, collaborate with global teams, and guide development programs from late-stage discovery through post-approval.

You will contribute to PDMB leadership, mentoring scientists and advancing regulatory science in multiple modalities. This hybrid role is based near Rahway, NJ.