Senior Manager, Biomarker Research and Development

vor 2 Wochen


Schweiz Merck Sharp & Dohme (MSD) Vollzeit
Job Description

At Merck Sharp & Dohme (MSD), we are seeking a highly skilled Senior Manager, Biomarker Research and Development to join our team.

Key Responsibilities:

  • Assess non-clinical drug efficacy, mode of action, pharmacology and pharmacokinetics studies and ensure adherence to regulatory guidelines.
  • Stay updated with evolving regulatory requirements and ensure that studies meet regulatory standards.
  • Communicate with regulatory authorities, and convey, adapt, and influence internal stakeholders on non-clinical pharmacological issues.
  • Review of the non-clinical pharmacologic reports by external partners includes evaluation of the quality and adequacy of the various assessments (pharmacology, safety pharmacology, etc).
  • Provide expert scientific support in the areas of non-clinical pharmacology, DMPK to project teams, and ensure non-clinical packages to support clinical development.
  • Facilitate project transitions to clinical development in close collaboration with discovery, translational and clinical scientists.

Qualifications:

  • PhD in pharmacology, or an area relevant to non-clinical pharmacology.
  • 5-10+ yrs of industry and research experience in drug development.
  • Hands-on experience in non-clinical pharmacology, PK/PD/Immunogenicity, and drug development in multiple therapeutic areas.
  • Extensive experience in developing the strategy & designing, directing & implementing non-clinical pharmacology plans for multiple compounds, both biologics and small molecules.
  • Knowledge of the current practices and issues in the non-clinical pharmacology, nonclinical metabolism and pharmacokinetics, and safety pharmacology areas.
  • Technical and practical knowledge of non-clinical pharmacology related global and China regulatory guidance and experience successfully delivering regulatory documents (reports, INDs, briefing documents, etc).
  • Demonstrated strong written and verbal communication skills - the ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience.

Preferred Qualifications:

  • Record of publishing in high profile scientific journals.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): no



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