As a member of the Clinical Assay Group within Global Clinical Pharmacology, you 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 in Molecular Biology, Microbiology, Immunology , Biochemistry, or related discipline and a minimum of 4 years related experience, MS degree and a minimum of 6 years of relevant industry experience, or BS and a minimum of 8 years relevant industry experience
- Minimum of 5 years of industry or clinical laboratory experience in biomarker assays; method development, assay validation and implementation within clinical trials, employing a broad range of molecular technologies (e.g. NGS, PCR, ISH) 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.
- Experience interpreting 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.
- Experience working effectively in a highly matrixed environment, and executing multiple projects simultaneously.
- Strong 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 available
\nPfizer 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
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.