Senior DMPK Scientist: Impactful PK/ADME Leadership Hybrid

Merck & Co.; Boston (MA); Híbrido; USD 210 000 - 331 000; Tempo integral

Resumo da oferta

Merck & Co. in the USA (West Point area) seeks a Distinguished Scientist to lead Drug Metabolism and Pharmacokinetics (DMPK) submission expertise, guiding nonclinical PK strategies from early studies through lifecycle management.

You will influence regulatory filings, labeling discussions, and global portfolio decisions, partnering with PDMB, Regulatory Affairs, and other functions to ensure robust, compliant submissions.

Qualificações

• Minimum 15 years in DMPK with extensive experience as team representative in drug discovery and development programs.
• Strong scientific acumen and understanding of regulatory guidelines with track record in clinical candidates and first-in-human execution.
• Previous experience mentoring program teams on nonclinical and clinical issues.
• Strong leadership and ability to influence scientists across disciplines to steer strategic direction.
• Efficient communication skills for clear, concise documents and presentations.
• Experience authoring and reviewing nonclinical PK packages and regulatory sections (IBs, INDs, NDAs, etc.).
• Demonstrated ability navigating regulatory requirements for advancing candidates across modalities.

Responsabilidades

• Oversee nonclinical PK packages aligned with filing strategy and program safety positions.
• Represent PDMB in Label Approval Strategy Teams and regulatory discussions.
• Review investigator brochures, clinical trial applications, INDs, NDAs, and regulatory responses.
• Provide scientific and strategic oversight across therapeutic areas with cross-functional partners.
• Contribute to Clinical Pharmacology strategy including dose rationale in early studies.
• Ensure DMPK data practices meet regulatory expectations across countries/regions.
• Lead initiatives to improve policies and regulatory alignment with portfolio strategy.
• Serve as integration lead for in-licensing assets and high-priority programs.
• Develop future leaders in drug development and regulatory guidelines.

Conhecimentos

Drug Development

Drug Metabolism

Pharmacokinetics

Portfolio Strategies

Regulatory Filings

Regulatory Strategies

Regulatory Submissions

Scientific Leadership

Small Molecules

Formação académica

PhD or MSci in Pharmaceutical Sciences, Pharmacology or related field

Descrição da oferta de emprego

Merck & Co. in the USA (West Point area) seeks a Distinguished Scientist to lead Drug Metabolism and Pharmacokinetics (DMPK) submission expertise, guiding nonclinical PK strategies from early studies through lifecycle management.

You will influence regulatory filings, labeling discussions, and global portfolio decisions, partnering with PDMB, Regulatory Affairs, and other functions to ensure robust, compliant submissions.