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
#J-18808-Ljbffr
Keywords: Merck Gruppe - MSD Sharp & Dohme, Fairfield , Sr. Manager, Biomarker Research, Executive , Rahway, Connecticut
Didn't find what you're looking for? Search again!
Loading more jobs...