Job Summary
The Clinical and Translational Biomarker (CTB) Lead is responsible for driving the translational biomarker strategy of assigned assets within the PRD portfolio from FIH through registration and post marketing activities. They are also accountable and responsible for implementation of the biomarker 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.
The Clinical and Translational Biomarker Lead works within a team-oriented, matrix organization to develop and implement a clinical biomarker plan. 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.
The CTB Lead should strive to be recognized (internally and externally) as a translational medicine and biomarker measurement subject matter expert.

Primary Duties

• Delivers clinical biomarker strategies and assays to support POM/SOCA milestones, mechanism of action and disease modification biomarkers, patient selection, label claims and commercial differentiation.
• Assembles and leads collaborative biomarker sub-teams to develop, refine, and operationalize biomarker strategy.
• 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, clinical development plans, preparing submissions, addressing regulatory queries, developing commercial differentiation strategies, implementing 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 plan and report documents, biomarker statistical analysis plans, budgeting and invoicing, health agency submission documents, 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 biomarker and clinical teams 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 a CTB Group Lead. CTB Leads and Group Leads are represented on the Translation Clinical Sciences Leadership Team by the Head of CTB.
• Provides matrix Clinical Biomarker sub team leadership. Member of Clinical study teams and sub-teams requiring BM input, as appropriate.
• Collaborates closely with project team members, particularly with R&D Therapeutic Area Scientists and Clinical Leads, Clinical Pharmacology, Pharmacometrics & Systems Pharmacology, Clinical Bioanalytics, Medical Team Leads, Data Management, Clinical & Bioanalytical Statistics, and Clinical Operations.
• Other important partnerships include Pharmacokinetics, Dynamics and Metabolism (PDM), Drug Safety R&D, Medical Affairs, Regulatory, Oncology biomarker groups, PCRUs, Regulatory, Finance and Procurement, and Commercial.

Basic Qualifications

• PhD or equivalent in biology, immunology, biochemistry, molecular biology, clinical laboratory sciences, analytical chemistry/chemistry or related field and 2+ year(S) of relevant experience; MS degree and 6+ years of experience OR BS degree and 7+ years of experience.
• Ability to lead matrix teams made up of research, technical, and clinical colleagues.
• Experience in biomarker discovery and/or development and implementation of biomarkers into clinical protocols.
• Experience with clinical drug development, clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, analytical and clinical validation of biomarker assays, and/or 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.

Preferred Qualifications

• Demonstrated ability to understand disease biology and how it applies to biomarker application in multiple therapeutic areas.
• CRO management and outsourcing experience.
• In depth knowledge and ability to provide interpretation of GxP, CAP and CLIA regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
• Experience preparing regulatory submissions and addressing regulatory queries, interacting with regulatory authorities and supporting regulatory inspections.

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: Hybrid
The annual base salary for this position ranges from $135,100.00 to $225,100.00. 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.
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. This position requires permanent work authorization in the United States.
Medical

• Delivers clinical biomarker strategies and assays to support POM/SOCA milestones, mechanism of action and disease modification biomarkers, patient selection, label claims and commercial differentiation.
• Assembles and leads collaborative biomarker sub-teams to develop, refine, and operationalize biomarker strategy.
• 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, clinical development plans, preparing submissions, addressing regulatory queries, developing commercial differentiation strategies, implementing 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 plan and report documents, biomarker statistical analysis plans, budgeting and invoicing, health agency submission documents, 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 biomarker and clinical teams 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