Senior DMPK Scientist — Regulatory Submissions & Strategy

Merck & Co.; Upper Gwynedd Township (Montgomery County); Híbrido; USD 210 000 - 331 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays and vacation

Annual bonus and long-term incentive

Resumo da oferta

Merck & Co. in USA (Pennsylvania, West Point) seeks a Distinguished Scientist to lead Drug Metabolism and Pharmacokinetics (DMPK) submission workstreams across development stages. The role emphasizes robust nonclinical PK packages for original marketing applications and lifecycle management.

The successful candidate will provide scientific and regulatory strategy, mentor teams, and influence labeling discussions, with hybrid work arrangements and a competitive package.

Qualificações

• Minimum 15 years in DMPK with leadership in drug discovery and development.
• Strong understanding of drug development process and regulatory guidelines.
• Experience mentoring across nonclinical and clinical issues.
• Proven ability to influence strategic direction and regulatory discussions.
• Excellent written and verbal communication for regulatory documents.

Responsabilidades

• Provide scientific and strategic oversight for development candidates across therapeutic areas.
• Represent PDMB in regulatory strategy discussions and labeling updates.
• Lead and mentor cross-functional teams to ensure robust PK packages for filings.
• Oversee due diligence reviews for in-licensing assets and integration.
• Contribute to development of future leaders in regulatory science.

Descrição da oferta de emprego

Merck & Co. in USA (Pennsylvania, West Point) seeks a Distinguished Scientist to lead Drug Metabolism and Pharmacokinetics (DMPK) submission workstreams across development stages. The role emphasizes robust nonclinical PK packages for original marketing applications and lifecycle management.

The successful candidate will provide scientific and regulatory strategy, mentor teams, and influence labeling discussions, with hybrid work arrangements and a competitive package.