Senior DMPK Scientist - PK & Regulatory Lead

Merck & Co.; South San Francisco (CA); Híbrido; USD 210.000 - 331.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Descripción de la vacante

Merck & Co. is seeking a Distinguished Scientist in DMPK to lead submission strategies and provide scientific oversight across multiple therapeutic areas. This senior role shapes regulatory filings, labeling discussions, and portfolio strategy within the PDMB leadership team.

The role emphasizes ensuring high-quality nonclinical PK data, program representation in cross-functional teams, and mentorship of future leaders in drug development and regulatory science.

Formación

• PhD or MSci in Pharmaceutical Sciences, Pharmacology or related field.
• Minimum 15 years in DMPK with leadership in drug discovery/development programs.
• Experience mentoring program teams on nonclinical and clinical issues.
• Strong leadership with ability to influence across disciplines.
• Excellent written and verbal communication for regulatory documents.

Responsabilidades

• Monitor late-stage development programs to 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 across therapeutic areas in collaboration with multiple functions.
• Contribute to Clinical Pharmacology strategy and PK/ADME considerations.

Conocimientos

Drug Development

Drug Metabolism

Pharmacokinetics

Portfolio Strategies

Regulatory Submissions

Regulatory Strategies

Regulatory Filings

Scientific Leadership

Small Molecules

Educación

PhD or MSci in Pharmaceutical Sciences, Pharmacology or related field

Descripción del empleo

Merck & Co. is seeking a Distinguished Scientist in DMPK to lead submission strategies and provide scientific oversight across multiple therapeutic areas. This senior role shapes regulatory filings, labeling discussions, and portfolio strategy within the PDMB leadership team.

The role emphasizes ensuring high-quality nonclinical PK data, program representation in cross-functional teams, and mentorship of future leaders in drug development and regulatory science.