Senior DMPK Scientist - Pharmacokinetics & Submissions

Merck

Boston (MA)

Hybrid

USD 210,000 - 331,000

Full time

14 hours ago

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Benefits offered by this job

Hybrid work arrangement

Job summary

Merck is seeking a Distinguished Scientist in the Drug Metabolism and Pharmacokinetics (DMPK) area to lead submission expertise across the development lifecycle. The role influences regulatory strategy, labeling discussions, and portfolio decisions within the PDMB leadership team.

Responsibilities include ensuring robust nonclinical PK packages, collaborating with Clinical Safety, Translational Medicine, and Regulatory Affairs, and mentoring teams to advance candidates from preclinical through

Qualifications

Minimum 15 years in DMPK with leadership in drug discovery and development programs.
Experience authoring nonclinical PK packages and regulatory documents (IBs, INDs, NDAs, etc.).
Ability to influence strategy and communicate complex science across functions.

Responsibilities

Monitor late-stage development programs and ensure robust nonclinical packages for filings.
Represent PDMB in Label Approval Strategy Teams and regulatory discussions.
Provide scientific oversight for development candidates across modalities and align with regulatory strategy.
Lead cross-functional initiatives to improve policies, procedures and strategic direction.
Contribute to regulatory filings, labeling discussions and lifecycle management.