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Sr. Manager, Biomarker Research

3 months ago

Beijing, China MSD Full time

Job Description

#Bioinformatics and Biomarker Research

 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

Required:

  • 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/5/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:10/05/2024


A job posting is effective until 11:59:59PM on the day BEFORE the 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