Translational Medicine Scientist (Contractor), Shanghai/Beijing
On-siteShanghai, Shanghai, China or Beijing, Beijing, China
Job Summary
Design, conduct, and coordinate clinical biomarker analysis activities for Pfizer Oncology and non-oncology portfolios, focusing on pharmacodynamic proof-of-mechanism, patient selection, and clinical proof-of-concept. Identify and evaluate candidate predictive biomarkers while developing clinical companion diagnostic tests to transition from early to late phase development. Act as point of contact to expedite study start-up and support biomarker assay transfer, compliance, and overall study quality. Work directly with external contract research organizations, vendors, academic collaborators, and key opinion leaders to execute analysis efforts. Collaborate within multi-functional program teams including Translational Oncology, Precision Medicine, Clinical Pharmacology, and Development Operations groups.
Required Qualifications
- demonstrated potential or ability to initiate and conduct clinical studies focusing on executing biomarker analyses that support clinical development objectives
- demonstrated understanding of pre-clinical and clinical disease biology, and the ability to apply that knowledge to drug development
- demonstrated understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development
- demonstrates ability to present biomarker data, study plans and tactics clearly and accurately to relevant audiences to obtain decision
- Able to work across many interfaces: clinical-regulatory; clinical-marketing; clinical-project management; clinical-development operations (biometrics, monitoring resource, study reporting)
- be able to manage and motivate contract research organizations
- Constantly challenge existing paradigms in clinical research and encourage breakthrough designs; work with clinical development operations on study design, data capture and retrieval, reporting
- Bias towards action to achieving goals
- Good at focused listening; can find common ground and get cooperation with minimum noise
- Had experience in executing and interpreting studies of cancer biomarkers in clinical trials, including biomarker development, validation, and clinical application
- familiarity with clinical trial design, logistics and regulatory issues
- familiarity with the development and regulatory approval of oncology companion diagnostics
- Demonstrated ability to work well in collaborative, multi-disciplinary team setting
- effective verbal and written communication skills
Desired Qualifications
- Preferred PhD
- Postgraduate training/certification /fellowship in a medical discipline or in drug development with focus on disease biology and biomarkers
- Candidates should possess understanding of cancer biology, cancer genetics and immunology, and demonstrate scientific productivity (e.g. doctoral thesis, publications, research reports, etc.)
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