Senior Manager, Companion Diagnostics

The Senior Manager of Clinical Diagnostics will oversee companion diagnostic strategy of multiple late and early-stage clinical oncology development programs. The successful candidate must possess a deep understanding of clinical biomarker development, the commercial testing landscape, and the global regulatory guidelines for companion diagnostic submissions. While the primary role of this position will focus on the development of assays for patient selection, the ideal candidate will also bring strategic leadership to define clinically and commercially viable patient selection strategies to enable drug development candidates to move through clinical development while collaborating closely with members of the Clinical Development, Regulatory and Commercial functions. Keys for success include leading cross-functional groups to deliver scientifically and commercially sound recommendations for diagnostic testing in patient selection trials and companion diagnostic strategies for both early and late-stage programs, flexibility and creativity in incorporating companion diagnostic development timing and communicating data and program impacts to key stakeholders and project teams. This position has the option of being based remotely or in either of our Bothell, Washington or South San Francisco offices.
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.

Requirements:

• 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.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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.
Relocation assistance may be available based on business needs and/or eligibility.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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