Development China Translational Medicine Scientist combines the understanding of disease biology with prior experience in clinical trial sample analyses to design, prioritize and successfully execute clinical translational studies that will inform key drug development decisions in the era of precision medicine.
The China Translational medicine scientist may act as point of contact to expedite study start-up and conduct and to support biomarker assay transfer, compliance and overall study quality.
Responsibilities
- Design, conduct and coordinate clinical biomarker analysis related activities involved in Pfizer Oncology and non-oncology portfolio, focusing on pharmacodynamic proof-of-mechanism/pharmacology, patient selection/stratification and clinical proof-of-concept (POC), and underlying disease biology of relevance to combination therapy and drug sensitivity or resistance.
- Conduct and coordinate activities related to identify and evaluate candidate predictive biomarkers and develop clinical companion diagnostic tests that will appropriately transition from early to late phase clinical development.
- Work directly with a variety of external contract research organizations/vendors as well as academic collaborators and key opinion leaders to execute clinical biomarker analysis efforts.
- Work collaboratively within highly integrated, multi-functional program teams that includes Translational Oncology, Precision Medicine, Clinical Pharmacology and Development Operations groups, as well as Clinicians, Statisticians, and Asset Team Leads.
Technical / Behavioral Competencies
- Technical Competencies
- Clinical Project Expertise: demonstrated potential or ability to initiate and conduct clinical studies focusing on executing biomarker analyses that support clinical development objectives
- Scientific Excellence: 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
- Presentation and Analytical Skills: demonstrates ability to present biomarker data, study plans and tactics clearly and accurately to relevant audiences to obtain decision
Behavioral Competencies
- Networking and Alliance Building: Able to work across many interfaces: clinical-regulatory; clinical-marketing; clinical-project management; clinical-development operations (biometrics, monitoring resource, study reporting)
- Influencing: be able to manage and motivate contract research organizations
- Innovation: Constantly challenge existing paradigms in clinical research and encourage breakthrough designs; work with clinical development operations on study design, data capture and retrieval, reporting
- Courage with decisiveness to Act: Bias towards action to achieving goals
- Conflict Management: Good at focused listening; can find common ground and get cooperation with minimum noise
Qualifications (Training, Education & Prior Experience)
Education:
- 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.)
Prior Experience:
- 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
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