The Senior Manager of Clinical Diagnostics will oversee development of diagnostic and patient selection strategies as part of therapeutic teams in a matrix environment. The successful candidate will bring technical leadership to identify and execute patient selection strategies to enable drug development candidates to move through clinical development while collaborating closely with clinical operations, regulatory and commercial teams. Keys for success include devising scientifically sound diagnostic testing strategies, effective implementation of assays into clinical trials, and communicating data and program impacts to key stakeholders and project teams. The ideal candidate will have deep technical and regulatory expertise in molecular methods for IVD development and approval. This role includes oversight of development efforts with both CLIA labs and IVD partners to support patient selection strategies, identification of patient response signatures and companion diagnostic development for regulatory approval. This position has the option of being based remotely or in either of our Bothell, Seattle, or South San Francisco offices.Responsibilities:
Lead development and validation of molecular biomarker assays.
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 companion diagnostic tests.
Support regulatory and commercial planning for approval and launch activities.
Requirements:
PhD, MD, or MD/PhD with 5+ years of experience (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 development and validation of molecular based tests including liquid biopsies.
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 $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% 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.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer 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.Medical