Biomarker Clinical Assay Lead (Manager)
POSITION SUMMARY
This position will sit within the Assay Development Group of the Companion Diagnostic Center of Excellence supporting clinical biomarker and diagnostic strategy development through scientific and technical oversight of biomarker and prototype diagnostic assays, clinical implementation, and management of external and internal partners in oncology and other therapeutic areas. You will bring technical leadership to devise scientifically sound biomarker and diagnostic testing strategies, effective implementation of assays into clinical trials, and communicating data and program impacts to key stakeholders and project teams.
KEY RESPONSIBILITIES:
Provide bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high-quality clinical biomarker and Diagnostic (Dx) data
Support assay development and timely availability of fit-for-purpose and Dx clinical biomarker assays to clinical Study Teams
Function as key point of contact with external and internal clinical labs, with oversight responsibilities for agreements, work plans, budget and invoices, assay development, transfer, validation and associated report, sample analyses and associated report, data transfers and overall data quality
Provide technical support for selection, qualification and periodic audits of bioanalytical laboratories supporting oncology clinical trial biomarker and Dx assays as appropriate
Collaborate with Study Teams to ensure appropriate biomarker and Dx sample handling and processing steps are appropriately performed during clinical trials
Serve as subject matter expert for biomarker testing technologies (NGS, PCR, IHC flow cytometry, immuno-assays etc)
Collaborate with Asset Teams to manage the timely testing of clinical trial samples and the analysis and reporting of the associated data
MNIMUM QUALIFICATIONS
PhD in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics) OR
MS in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics) with 2+ years of relevant experience
Experience with the research and development of biologic therapeutics, biomarker assay development, validation and execution in clinical trials
Experience and expertise in biomarker selection trials
An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and Dx
Development, validation, and implementation of a broad range of platform technologies within clinical trials (e.g. NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies)
Demonstrated understanding of clinical laboratory regulatory and compliance requirements (GLP, GCP, GCLP, CLIA, CAP)
Demonstrated ability to think strategically and creatively while contributing to multiple projects simultaneously
Experience working productively in a collaborative, multi-disciplinary and diverse team setting
Excellent communication and organizational skills; able to convey complex scientific and business issues to devise, reach agreement on, and implement solutions
Experience collaborating, leading, influencing, and motivating others
PREFERRED QUALIFICATION
CRO management and outsourcing engagement expertise
Work Location Assignment: On Premise
The annual base salary for this position ranges from $102,900.00 to $171,500.00. 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 Act
Pfizer 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 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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