Sr. Manager, Biomarker Research

Company: Merck Gruppe - MSD Sharp & Dohme
Location: Rahway
Posted on: October 24, 2024

Job Description:

Job Description#Bioinformatics and Biomarker ResearchKey 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.QualificationsRequired:
  • 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:
    • Record of publishing in high profile scientific journals.Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements: Not ApplicableShift: Not IndicatedValid Driving License: NoHazardous Material(s): NoJob Posting End Date: 12/31/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R284604
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Keywords: Merck Gruppe - MSD Sharp & Dohme, Wayne , Sr. Manager, Biomarker Research, Executive , Rahway, New Jersey