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Senior Manager, Companion Diagnostics
2 months ago
We are seeking a highly skilled Senior Manager to lead our Companion Diagnostic strategy for multiple late and early-stage clinical oncology development programs. As a key member of our team, you will be responsible for overseeing the development of assays for patient selection, collaborating closely with members of the Clinical Development, Regulatory, and Commercial functions, and providing strategic leadership to define clinically and commercially viable patient selection strategies.
Key Responsibilities- Design clear strategic recommendations for incorporating clinical testing and companion diagnostic development into patient selection trials, incorporating scientific, regulatory, commercial, and global considerations.
- Provide oversight of the integration of clinical assays or IVDs into clinical trials, including reviewing sections of clinical protocols, lab manuals, and/or ICFs.
- Provide regulatory expertise to all programs, author key sections of regulatory documents, and represent Seagen at regulatory interactions.
- Collaborate with the Clinical Development Operations, Regulatory, and Commercial functions to drive diagnostic and clinical testing strategy from IND to Launch.
- Candidates must have a Ph.D. or MD with proven experience developing approved companion diagnostics.
- Demonstrated experience in the development of companion diagnostic and biomarker strategies, including in-depth knowledge of biomarker-based indication selection, assay development, analytical validation, clinical validation, and commercial launch of companion diagnostics in oncology.
- Broad understanding of clinical development processes and regulatory approval processes of companion diagnostics.
- Expertise in commercial implementation of assay methodologies such as PCR and NGS.
- Experience with communicating precision-medicine strategy, issues, and risks in written and verbal format to company senior leadership team and other governing bodies.
Pfizer offers a comprehensive and generous benefits package, including a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday, and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage.
Relocation assistance may be available based on business needs and/or eligibility.
