Clinical and Translational Biomarker Lead

Pfizer • Cambridge, MA

5d • Hybrid

About The Position

The Clinical and Translational Biomarker (CTB) Lead will be responsible for developing translational biomarker strategies for assigned assets with a focus on weight management related comorbidities and cardiometabolic disease within the PRD portfolio from LD thought FIH to 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.

Requirements

• PhD or equivalent in biology, immunology, biochemistry, molecular biology, clinical laboratory sciences, analytical chemistry/chemistry or related field and 1+ year(s) of relevant experience; MS degree and 5+ years of relevant experience OR BS degree and 6+ years of relevant 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.
• Permanent work authorization in the United States.

Nice To Haves

• Research experience and knowledge of biology underlying obesity, related comorbidities, cardio metabolism or related disease areas including relevant clinical biomarkers.
• Demonstrated translation 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.

Responsibilities

• 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 lead 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 biomarkers 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 CRC studies and research initiatives managed by Medical Affairs.
• Works 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.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree