Senior Manager(s), Clinical Diagnostics

The Senior Manager, Clinical Diagnostics will support development of Diagnostics and Global Diagnostic Strategies across therapeutic areas. We are seeking a creative and motivated leader to identify and implement diagnostic strategies to enable and support the global development and commercialization of differentiated therapies. The successful candidate will bring technical leadership to devise scientifically sound diagnostic testing strategies, effective implementation of assays into clinical trials, and communicating data and program impacts to key stakeholders and project teams.
Responsibilities:

• Lead the development and implementation of diagnostic strategies for individual projects and/or therapeutic areas
• Serve as subject matter expert in state-of-the-art biomarker testing technologies (NGS, PCR, flow cytometry, immuno-assays etc)
• Provide oversight of the integration of clinical assays or IVDs into clinical trials including authoring sections of clinical protocols, lab manuals and ICFs.
• Collaborate with Asset Teams to manage the timely testing of clinical trial samples and the analysis and reporting of the associated data.
• Manage IVD partners through development, validation, and approval of diagnostic tests.
• Support regulatory and commercial planning for approval and launch activities.

Requirements:

• PhD, MD, or MD/PhD with experience in companion diagnostics (or equivalent) in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics)

• Experience with the research and development of biologic therapeutics, biomarker assay development, validation & execution in clinical trials
• Experience and expertise in biomarker selection trials
• Expertise and extensive experience with the IUO development and validation of molecular based tests, immuno-assays and/or flow cytometry
• An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and diagnostics
• Excellent communication & organizational skills; able to convey complex scientific and business issues to devise, reach agreement on, and implement solutions
• Ability to collaborate, lead, influence, and motivate others

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.
Research and Development