Distinguished Scientist, Pharmacokinetics

Merck seeks a Distinguished Scientist in Drug Metabolism and Pharmacokinetics to lead submission strategy and regulatory support across the development pipeline. This senior role requires strategic oversight of nonclinical PK packages, portfolio decisions, and cross-functional collaboration to ensure robust filings from first-in-human through post-market.

Responsibilities

• Monitor late-stage and post-marketing programs to ensure nonclinical packages support original and supplemental applications
• Represent PDMB in regulatory strategy teams and label approval discussions with clinical and nonclinical partners
• Review investigator brochures, INDs, NDAs, and regulatory responses to support global trials and registration
• Oversee due diligence reviews for in-licensed assets and serve as program representative for high-priority candidates
• Develop internal leaders and contribute to strategic initiatives improving policies and regulatory alignment

Requirements

• PhD or M.Sci. in Pharmaceutical Sciences, Pharmacology, or related field
• Minimum 15 years DMPK experience with drug discovery and development program support
• Track record of successful clinical candidate and first-in-human execution
• Experience authoring and reviewing nonclinical PK packages and regulatory documents (IBs, INDs, NDAs, BLAs)
• Strong leadership and ability to influence scientists across multiple disciplines
• Knowledge of filing and labeling requirements for major world markets
• Experience navigating drug development across modalities from preclinical through Phase 4