As a member of the Clinical Assay Group within Global Clinical Pharmacology, the Biomarker Clinical Assay Lead will play a critical role in supporting clinical biomarker assay 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 analytical assays and data.ROLE RESPONSIBILITIES
- Serves as a member of the clinical study team and biomarker 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.
As appropriate, additional responsibilities may include the following:
- Leads development of novel complex fit-for-purpose molecular biomarker methodologies, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identifies technology/capabilities gaps and proposes mitigation strategies, including development of novel technical capabilities with vendors.
- Scientifically evaluates complex data (i.e. evaluates aberrant results and data trends), anticipates and corrects potential issues, and able to appropriately guide study teams through complex issues resolution.
- 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. Guides and leads study teams with respect to the selection and execution of the analytical strategy.
- Functions as key point of contact with external & internal laboratories and leads selection, qualification, performance evaluation, periodic visits and audits of CRO laboratories conducting clinical biomarker assays.
- Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
- Contributes to the development of Best Practices processes, templates, and policies
- Maintains up-to-date knowledge of current and novel biomarker assays & techniques, global regulatory guidance's & expectations, and industry best practices.
- Supports challenging clinical trials and programs involving novel modalities, cross-company collaborations and/or external partnerships.
- As SME, assists clinical pharmacology leads in conducting due diligence activities.
- Leads internal and cross-functional organization initiatives, development and implementation of the relevant policies and best practices, and demonstrates internal and external influence.
- Provides subject matter expertise, guidance and mentoring to colleagues.
PhD or equivalent in molecular biology, microbiology, immunonology , biochemistry, or related field. M.S. and B.S. degrees will be considered based on relevant industry experience. Minimum of 5-8 years of industry or clinical laboratory experience ib biomarker assays; method development, assay validation and implementation within clinical trials, employing a broad range of molecular technologies (e.g. NGS, PCR, ISH etc) and associated data analysis methods as well as other cell based and circulating biomarker technologies
- Recognized scientific and technical leadership and accomplishments in molecular biomarker methods and data analysis as applied to clinical research supported by publications and presentations.
- Expertise in development, validation and troubleshooting of complex fit-for-purpose biomarker methods in various matrices (including tissue) using broad range of methodologies and techniques for biomarker clinical sample analysis.
- In depth knowledge and ability to provide interpretation of GxP, and/or CAP and CLIA regulations governing conduct of clinical trials and regulatory guidance's and expectations relevant to regulated and/or exploratory biomarker bioanalysis.
- Demonstrated CRO management and outsourcing experience.
- Direct experience interacting with regulatory authorities and supporting regulatory submissions & regulatory queries, and/or inspections.
- Demonstrated ability to work effectively in a highly matrixed environment, and execute multiple projects simultaneously.
- Highly effective communication skills: verbal, written, and presentation.
- Clinical infectious disease research experience
- Understanding of clinical trial design, overall principles of clinical development, and related disciplines (e.g., clinical pharmacology, PK/PD, biology, formulation and drug
- Working knowledge of other bioanalytical platforms other than core expertise such as Proteomics platform, Ligand Binding Assay technologies, etc.
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.PHYSICAL/MENTAL REQUIREMENTS
Relocation support availablePfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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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.