Sr. Manager, Biomarker Research
1 month ago
Job Description
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R284604
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