1+ months

Biomarker Clinical Assay Lead, Director

Pfizer
Groton, CT 06340
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ROLE SUMMARY

As a member of the Clinical Assay Group within Global Clinical Pharmacology, the successful candidate will play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant biomarker bioanalytical assays and data.



ROLE RESPONSIBILITIES

Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development and review, preparing submissions, addressing regulatory queries, developing and implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.

Effectively partners across clinical stakeholders (e.g., Clinical Pharmacology ECD, WRD RUs, BMD and ECD Precision Medicine) in providing scientific guidance and in developing cohesive pan-Pfizer strategies for regulated biomarker analytics enabling PKPD modeling/analysis and dose selection.

Strategically leads development and implementation of bioanalytical strategies and cutting-edge technologies to enable clinical PKPD modeling, dose selection, and ensuring regulatory acceptance in the absence of regulatory guidance

Represents Pfizer science and best practices in Biomarker bioanalytics internally and externally through active participation with IQ consortiums, Pharma organizations, regulatory authorities and other external biomarker community forums.

Leads and assists CAG colleagues & project teams in development/selection of novel complex fit-for-purpose biomarker methodologies, execution of the analytical strategy, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. May have responsibility for dotted/direct line management of staff.

Leads and oversees fit-for-purpose biomarker assay lifecycle management from early stage to registration encompassing analytical development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations.

Scientifically evaluates complex data (i.e. evaluates aberrant results and data trends), anticipates and corrects potential issues, and able to appropriately guide study teams and CAG colleagues through complex issue resolution.

Functions as key point of contact with external & internal laboratories and leads selection, qualification, performance evaluation, periodic visits of CRO laboratories conducting clinical biomarker assays & participating in the MQA audits.

Supports challenging clinical trials and programs involving novel modalities, cross-company collaborations and/or external partnerships in addition to Clinical Assay Group study responsibilities which include development and review of documents and processes such as CRF, data, and clinical site lab manual setup, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.

Leads external & internal and cross-functional organization initiatives, development of best practices and demonstrates internal and external influence.



BASIC QUALIFICATIONS



**"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."**



PhD in biology, immunology or analytical chemistry/biochemistry with a minimum of 10 years of experience, or MS with a minimum of 15 years of relevant industry or bioanalytical experience with novel technologies deployed in fit-for-purpose biomarker assay development, validation, and sample analyses using relevant methodologies, including chromatographic/mass spectrometry and ligand binding platforms.

Recognized scientific and technical leadership and accomplishments in regulated Biomarker bioanalytics supported by extensive publications and presentations

Proven track record and ability to influence regulatory and industry environment/scientific community.

Direct experience interacting with regulatory authorities and supporting regulatory submissions & regulatory queries, and inspections.

Demonstrated ability to create collaborative environment and partner effectively across lines and organizations, internally and externally.

Demonstrated ability to understand disease biology and its relevance to biomarker strategy, PKPD relationships, dose selection and clinical development plans.

Expertise in development, validation and troubleshooting of complex fit-for-purpose biomarker methods in various matrices (including tissue) using broad methodologies and novel techniques such as hybrid LBA-LCMS for clinical biomarker analysis.

Strong understanding of critical reagent generation & lifecycle management.

In depth knowledge and ability to provide leadership and guidance to clinical teams and CAG colleagues in interpretation of GxP, CAP and CLIA regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.

Deep understanding of clinical trial design, principles of clinical development, and related disciplines (e.g., clinical pharmacology, biology, formulation and drug product).

Demonstrated CRO management and outsourcing experience.

Highly effective communication skills: verbal, written, and presentation.



PREFERRED QUALIFICATIONS

Experience with cell based assays, flow cytometry, enzymatic and molecular assays.

Prior experience with training, mentoring and managing colleagues.



**Other Job Details:**



+ Additional Location Information: Groton CT, Cambridge MA, Andover MA

+ 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.



Medical
Posted: 2020-02-03 Expires: 2020-05-04

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Biomarker Clinical Assay Lead, Director

Pfizer
Groton, CT 06340

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