Precision Medicine, Clinical Biomarker Lead
Company: Pfizer
Location: Cambridge
Posted on: January 8, 2021
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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
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