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 and translational research
activities involved in the evaluation and development of drugs within the
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.
* 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 and expand clinical translational research efforts.
* Work collaboratively within highly integrated, multi-functional program
teams that includes scientists within Discovery Research, Research Precision
Medicine, Computational Biology, 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 design,
initiate and conduct clinical studies focusing on integrating and 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
clinical data, study plans and tactics clearly and accurately to relevant
audiences in order 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 investigators and 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, MD, MD/PhD, Pharm. D or equivalent qualifications.
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 industry experience in designing, 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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Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
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