Precision Medicine, Clinical Biomarker Lead

Company: Pfizer
Location: Cambridge
Posted on: January 8, 2021

Job Description:

**Job Description** The Precision Medicine Clinical Biomarker Scientist works collaboratively across research, technical, and clinical teams to define and operationalize early clinical biomarker strategies within a research unit portfolio. The Clinical Biomarker Lead will establish and coordinate interactions between project teams, assay specialists, CRO's, PM Clinical Laboratories, and the internal biomarker community. A successful candidate can communicate and lead within a team-oriented, matrix organization, multitask/prioritize multiple projects, and leverage information from a variety of sources in order to deliver effective, fit for purpose biomarker strategies, quality data, and interpretation of biomarker results to drive early clinical development. In addition, the Clinical Biomarker Lead will present and share project status, issues, and learnings to all stakeholders to ensure a culture of transparency and continuous improvement. **Role Responsibilities** + Collaborates with research and clinical colleagues to develop and defend scientifically rigorous translational and exploratory biomarker strategies that assess signs of pharmacology, proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and generate an understanding of the variability in patient response. + Assembles and leads collaborative biomarker sub-teams, made up of colleagues with relevant technical, research, or clinical expertise, to develop, refine, and operationalize biomarker strategy. + Participates in above asset initiatives such as phase 0 natural history and methodology studies to help expand and sustain the portfolio pipeline. + Ensures timely biomarker assay development, fit for purpose validation and resourcing. + Contributes clinical protocol, lab manual, and informed consent language specific to biomarkers. + Leverages external contract research organizations and vendors along with appropriate internal laboratories to execute biomarker analyses. + Serves on clinical operations teams to endure compliance around clinical biospecimen management and vendor oversight. + Ensures timely delivery of internally or externally generated biomarker data for analysis. + Works with biomarker and clinical teams to interpret biomarker results in the context of the clinical study. + Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications. **Qualifications** + PhD with minimum of 8+ years of drug discovery/development experience. Industry experience strongly preferred. + Background in metabolic, cardiovascular, inflammatory, or rare genetic diseases preferred. + Candidate should have a good working knowledge of the application of various biomarker technologies (eg. flow cytometry, ligand binding assays, mass spectrometry) as well as various high dimensional exploratory platforms (eg. transcriptomic, proteomic, metabolomics). + Experience in clinical drug development, clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, analytical and clinical validation of biomarker assays, and/or vendor interactions preferred. + Experience in genetically defined rare diseases, NASH/fibrosis, inflammation and/or immunology a plus + Proven ability to effectively lead matrix teams made up of research, technical, and clinical colleagues. + Builds connections by developing positive, collaborative partnerships. + Demonstrated ability to manage and contribute effectively to multiple projects at once. + Highly effective verbal and written communication skills. + \#LI-PFE **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. Medical

Keywords: Pfizer, Cambridge , Precision Medicine, Clinical Biomarker Lead, Healthcare , Cambridge, Massachusetts