Precision Medicine, Clinical Biomarker Lead

Cambridge, Massachusetts
July 30 2021
Position Type
Full Time
Organization Type

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.

  • 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.

Other Job Details:
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE

Sunshine Act

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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.


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