1+ months

Biomarker Clinical Assay Lead Manager

La Jolla, CA 92037

+ Provide bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high quality clinical biomarker data within Global Product Development.

+ Support assay development and timely availability of fit-for-purpose clinical biomarker assays to clinical Study Teams.

+ Function as key point of contact with external commercial or academic clinical laboratories, as well as internal clinical lab., with oversight responsibilities for agreements, work plans, budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality.

+ Provide technical support for selection, qualification and periodic audits of CRO laboratories supporting clinical trial biomarker assays.

+ Coordinate with Study Teams and clinical operations to ensure appropriate biomarker sample handling and processing steps are appropriately described in the clinical trial Laboratory Manual

+ Contribute to the ongoing development of Best Practices processes and templates.

+ Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance and compliance.

**Basic Qualifications:**

+ PhD or equivalent with experience in Clinical Laboratory Sciences, within one or multiple therapeutic areas including Oncology, Rare Diseases, Gene Therapy, and Inflammation.

+ Well Qualified candidates with B.S. and M.S will be considered based on experience in biomarker analyses and clinical laboratory testing in Rare Disease, Inflammation, Gene Therapy, Oncology, Molecular Oncology, or Hematopathology.

+ Minimum of five years of industry or clinical laboratory experience in biomarker assay development, assay validation and implementation within clinical trials, employing a broad range of platform technologies (e.g. NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies)

+ Demonstrated understanding of clinical laboratory regulatory and compliance requirements

+ Demonstrated ability to think strategically and creatively while contributing to multiple projects simultaneously

+ Ability to work productively in a collaborative, multi-disciplinary and diverse team setting

+ Highly effective verbal and written communication skills

**Preferred Qualifications:**

+ Certification in Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) is a plus.

+ CRO management and outsourcing engagement expertise preferred

+ **\#LI-PFE**

+ **Other Job Details:**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

**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.



Posted: 2020-03-18 Expires: 2020-07-17

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Biomarker Clinical Assay Lead Manager

La Jolla, CA 92037

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