Job Description

Biomarker Operation, Senior Manager

Location: Shanghai

We are seeking a highly motivated scientist to drive clinical biomarker operation implementation to support clinical development programs across therapeutic areas in China. 

Key responsibilities:

She/He will be working with global and China biomarker lead and/or platform lead to develop China biomarker strategy and implementation plan to support clinical development programs across therapeutic areas.Work global vendor management team, biomarker operation project management team, companion diagnostic operation team to ensure vendor validation and efficient execution of key assay setup.Collaborate with cross-functional study team for relevant biomarker sections of clinical study documents (clinical trial protocol, ICF, etc.).Participate as a key contributor of biomarker assay/lab documents (statement of work, lab manual, specimen collection procedure, etc.).Coordinate biomarker sample and assay logistics planning/execution and serve as a key point of contact in China with vendors/study teams for issue resolution.Develop project plans with clearly defined timelines and deliverables and implement necessary risk mitigation strategies.Contributes to biomarker study design, assay platform selection and data analysis of investigator-initiated studies.

Qualifications

Required:

M.S. or Ph.D. in the Life Sciences related subjects and with at least 5 years’ experience in pharmaceutical (translational medicine) or global CRO lab (pathology/genomic).Broad technical experience in biomarker assays including but not limit to: IHC, immunoassay, flowcytometry, genetics/genomics.Understanding of drug discovery & development including early/late-stage development, approval process and life cycle management.Must be detail oriented with strong organization skills in order to manage and meet deliverables.Demonstrate exceptional written and verbal communication skills in English and Chinese.Experience with a matrix environment and ability to effectively collaborate with colleagues from a wide range of disciplines.

Preferred:

Understanding of drug development process, and key concepts in clinical trial study.Understanding of the major concepts of oncology biology.Record of publishing in high profile scientific journals.Experience with clinical biomarker operations, including HGRAC application and project management, is highly valued.

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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:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

05/15/2025

*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:R336227