Job Description

Biomarker Operation, Senior Manager/Associate Director

Location: Shanghai/Beijing

We are seeking a highly motivated scientist to drive clinical biomarker/diagnostic assay/lab setup to support clinical development programs across therapeutic areas in China.

Key responsibilities:

• He/She will be working with cross-functional clinical study team to identify assay/lab setup needs, assist decision-making and implement risk management, to support clinical development programs across therapeutic areas.
• He/She will be working with global vendor management team, platform leads, and China Biomarker leads, platform leads to coordinate/lead assay/lab evaluation.
• He/She will be overseeing the course of each assay setup to meet timeline of clinical study initiation and exploratory biomarker data generation.
• He/She will be a key point of contact in China with vendors/study teams for issue resolution.

Qualifications

Required:

• M.S. or Ph.D. in the Life Sciences related subjects and with at least 5 years’ experience in pharmaceutical (translational medicine, lab vendor management) or global CRO lab (assay development, project management).
• Broad technical experience in biomarker assays including but not limited to: IHC, immunoassay, flowcytometry, genetics/genomics.
• Understanding of assay development, transfer and validation for drug discovery & development including early/late-stage development.
• Must be detail oriented with strong organizational 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.
• Experience with clinical biomarker operations, including specimen importation and exportation, is highly valued.

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:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Required Skills:

Assay, Assay, Assay Development, Biochemical Assays, Biochemistry, Bioinformatics, Cell-Based Assays, Cell Biology, Clinical Testing, Communication, Cytogenetics, Cytopathology, Data Analysis, Detail-Oriented, Drug Development, Ethical Compliance, High-Throughput Screening, Immunoassays, Immunology, Immunoprecipitation, Immunotherapy, Mammalian Cell Culture, Molecular Biology, Professional Networking, Protein Expression {+ 3 more}

Preferred Skills:

Biomarkers, Clinical Development, Early Drug Development

Job Posting End Date:

12/31/2025

*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.