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, 02Precision 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:02 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.02
* Demonstrated ability to work well in collaborative, multi-disciplinary team
setting; effective verbal and written communication skills
0202
Work Location Assignment:02Remote - Field Based
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employment opportunity legislation in each jurisdiction in which it operates.
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