Senior DMPK Scientist, Pharmacokinetics & Submissions

MSD

Northern (KY)

Hybrid

USD 210,000 - 331,000

Full time

5 days ago

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Benefits offered by this job

Medical, dental, vision benefits

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co. is seeking a Distinguished Scientist in Pharmacokinetics to lead DMPK strategy and regulatory submissions across programs. You will guide nonclinical PK packages, interact with global teams, and influence development decisions from preclinical to post-approval.

The role emphasizes collaboration, scientific leadership, and regulatory excellence. Ideal candidates have 15+ years in DMPK, PhD or MSc in a related field, and a proven record of navigating regulatory requirements across

Qualifications

Minimum 15 years in DMPK with leadership in drug discovery and development.
Strong understanding of regulatory guidelines and filing processes.
Experience mentoring program teams and influencing strategic direction.

Responsibilities

Oversee nonclinical PK packages to support regulatory filings (OMA/sNDA).
Represent PDMB in label strategy and regulatory discussions with agencies.
Review regulatory documents to support global trials and submissions.
Provide scientific oversight across therapeutic areas and collaboration with cross-functional teams.
Lead continuous improvements in data/documentation for regulatory compliance.