Role Summary
The Clinical and Translational Biomarker (CTB) Lead will be responsible for developing translational biomarker strategies for assigned assets with a focus on inflammatory and autoimmune disease within the Pfizer Research & Development portfolio from Lead Development through FIH, through Phase 2 and 3 including registration and post-marketing activities. The lead is also accountable and responsible for implementation of this strategy 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. They contribute to biomarker sections of the clinical development plans, clinical protocols, internally- and externally-facing presentations and manuscripts, regulatory filings, label claims and registration paths.
Role Responsabilities
Utilize understanding of disease biology and therapeutic mechanism of action in collaboration with team to develop and deliver clinical biomarker strategies and assays.
Deliver biomarker data and insight to support program decisions for key milestones (eg POM/SOCA etc), label claims, commercial differentiation and targeted reverse translation.
Assembles and leads collaborative biomarker sub-teams to develop, refine, and operationalize biomarker strategy.
Serves as a member of the clinical study team and as a biomarker subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development and review, clinical development plans, preparing submissions, addressing regulatory queries, developing commercial differentiation strategies, implementing biomarker bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Leads and oversees fit-for-purpose biomarker assay lifecycle management including bioanalytical development and method design, validation, data quality review, sample analyses & reporting to meet evolving program objectives and regulatory expectations.
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. Assists CROs with effective troubleshooting of biomarker assays and issue resolution.
Contributes to and reviews clinical protocols, clinical development plans, bioanalytical plans and report documents, biomarker statistical analysis plans, budgeting and invoicing, health agency submissions, lab manuals, CRF and data transfer specifications, commercial differentiation strategies and informed consent language document sections specific to biomarkers in compliance with clinical SOPs & policies, and regulatory guidance.
May participate in above asset initiatives such as Phase 0 natural history and methodology studies to help expand and sustain the portfolio pipeline.
May support due diligence activities as Biomarker SME.
May consult on clinical research collaboration (CRC) studies and research initiatives in partnership with Medical Affairs colleagues.
Partners with Clinical Pharmacology, Pharmacometrics & Systems Pharmacology Biomarker Statistics and Clinical to interpret biomarker results in the context of clinical studies.
Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.
Maintains up-to-date knowledge of assay technologies, clinical laboratory standards, global regulatory guidance & expectations, and industry best practices.
Contributes to the development of Best Practices processes, templates, and policies.
Organizational Relationships
Reports to the Clinical and Translational Biomarker Group Lead.
Provides matrix Clinical Biomarker sub team leadership with research, technical, and clinical colleagues.
Collaborates closely with project team members, particularly with R&D Therapeutic Area Scientists and Clinical Leads, Clinical Pharmacology, Pharmacometrics & Systems Pharmacology, Clinical & Bioanalytical Statistics, PCRUs and Medical Team Leads.
Other important partnerships include Clinical Bioanalytics, Clinical Operations, Data Management, Pharmacokinetics, Dynamics and Metabolism (PDM), Medical Affairs, Drug Safety, Regulatory, RWE, Quality and Procurement.
Qualifications
Must-Have
PhD or equivalent in biology, immunology, biochemistry, molecular biology or related field and 1+ year(s) of relevant experience; MS degree and 5+ years of experience or BS degree and 6+ years of experience.
Experience in biomarker discovery and/or development and implementation of biomarkers plans in clinical development.
Experience with clinical drug development, clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, analytical and clinical validation of biomarker assays, and vendor interactions.
Expertise in development, validation and troubleshooting of complex biomarker methods in various matrices (including tissue) using a broad range of methodologies and techniques for biomarker clinical sample analysis.
Demonstrated ability to think strategically, work effectively in a highly matrixed environment, and execute multiple projects simultaneously
Demonstrated ability to create collaborative environments and partner effectively across lines and organizations.
Highly effective communication skills: verbal, written, and presentation.
Nice-to-Have
Research experience and knowledge of biology underlying inflammatory diseases including autoimmune disease and inflammatory conditions spanning dermatology, respiratory, intestinal, fibrotic, and neuroinflammatory disease areas, including relevant clinical biomarkers.
Demonstrated translational biomarker experience supporting projects from lead development through to submission
Experience preparing regulatory submissions and addressing regulatory queries, interacting with regulatory authorities and supporting regulatory inspections.
Understanding of GxP, CAP and CLIA regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to clinical biomarkers measurement.
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.
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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 benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Medical
