As a member of the Early Development, Translational and Immuno-Oncology group within Pfizer Oncology, the successful candidate will lead clinical teams in translating our expanding understanding of disease biology and biomarker technology into competitive clinical development strategies in immuno-oncology. The candidate will combine a deep understanding of cancer and immunology with experience in clinical biospecimen analyses to design and execute clinical translational studies that inform drug development decisions.
Guide development of biologically-informed, scientifically rigorous, innovative and competitive clinical translational research strategies.
Implement the translational strategies in clinical studies of Pfizer Oncology anti-cancer drugs, focusing on proof-of- pharmacology, patient selection to support early clinical proof-of-concept, and underlying mechanisms of treatment resistance and potential synergy in combinations.
Analyze, interpret, and report results of clinical biomarker analyses, including support of regulatory filings.
Use insights from this research to support development of clinical companion diagnostic tests as needed.
Work collaboratively within highly integrated, multi-functional clinical program teams encompassing development (clinical, clinical pharmacology, statistics, development operations) and research line functions, including close interactions with biology and computational scientists, clinical biomarker assay specialists, diagnostics leads and asset team leadership
Work collaboratively with academic collaborators to execute and expand clinical translational research priorities.
Work with external contract research organizations/vendors to execute clinical biomarker analyses.
Role Qualifications
Educational Background:
Minimum: Advanced degree (PhD, Pharm. D.) with focus on cancer biology and/or immunology. Candidates should possess an advanced and current understanding of cancer biology, cancer genetics and immunology (immuno-oncology).
Prior Experience:
Minimum of five years or more of industry experience demonstrating excellence in designing, executing and interpreting studies of cancer biomarkers in clinical trials, including biomarker development, validation and clinical application (applicants with less industry experience who have particular strength in other relevant areas of background experience may be considered for a position at the level of Associate Director)
Experience with or exposure to clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, and vendor interactions.
Direct experience and/or familiarity with state-of-the-art technologies applicable to cancer biomarker and/or immune response analysis (such as immunohistochemistry, immunofluorescence, flow cytometry, in situ hybridization, nucleic acid analysis, gene expression profiling, molecular pathology, automated platforms, or digital image analysis)
Familiarity with analytical and clinical validation of biomarker assays.
Demonstrated ability to think strategically and creatively while contributing to multiple projects.
Ability to work effectively in a highly collaborative, multi-disciplinary team setting.
Highly effective verbal and written communication skills
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