• 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.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Excellent communication, analytical and organizational skills.

The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Medical