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, validation 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 and Dx 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 

MINIMUM 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 and Dx 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  

OTHER JOB DETAILS

• Last Date to Apply for Job: January 30th

• Work Location Assignment: Hybrid

• No relocation support available

The annual base salary for this position ranges from $106 000,00 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