Job Description
Clinical Pathology , Manager/Senior Manager
Location: Shanghai
We are seeking a highly motivated clinical pathology/histology scientist to drive clinical pathology implementation to support clinical development programs across therapeutic areas in China.
Key responsibilities:
- Collaborate with clinical teams and diagnostic partners to support drug and diagnostic development in China.
- Work with global clinical imaging and pathology team, vendor management team, clinical operation team, etc. to ensure vendor validation and efficient execution of key assay setup, in the field of anatomic pathology and histology.
- Participate as a key contributor of molecular pathology and clinical pathology assay/lab documents (statement of work, lab manual, specimen collection procedure, etc.).
- Coordinate pathology 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.
- Provide expertise for pathology/histology related question in support of drug registration and applicable CDx registration
Qualifications
Required :
- MD or MD/PhD with formal training in Pathology/Histopathology with at least 5 years of experience in clinical diagnosis with top clinical institutions, pharmaceutical or global CRO labs
- Extensive technical experience in biomarker assays including but not limit to: in situ hybridization, immunohistochemistry, multiplex immunofluorescence, digital pathology
- Rich project experience working with investigators or pharmaceutical involving patient selection, biomarker strategies, and other relevant clinical trial activities.
- 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.
- Experience with clinical biomarker operations, including HGRAC application and project management, is highly valued.
Current Employees apply
Current Contingent Workers apply
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:
07/31/2025
*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.
Requisition ID: R345635