Biomarker Operations Associate
Company: H3 Biomedicine
Posted on: January 12, 2022
Location: Cambridge MACambridge, MA-based H3 Biomedicine (H3B)
is a leading company in cancer genomics driven drug discovery,
delivering on the promise of precision medicine. The company was
launched in 2011 with an unprecedented $200 million in initial
funding from Eisai, plus a continued ongoing commitment to fund
H3Bs robust discovery pipeline and clinical programs. Now with
three clinical stage anti-cancer molecules in active development,
H3B is able to uniquely leverage distinct insights from cancer
genomics and real-life patient data to advance its projects to
clinical proof of concept and beyond. H3B embraces a novel business
model in which it collaborates with Eisai, a leading global
pharmaceutical company, to create a prolific drug discovery engine
and partnership platform.
This role is primarily focused on leading and coordinating clinical
biomarker activities between H3 biomedicine (H3B) clinical
operations, data sciences and external vendors to ensure timely
delivery of biomarker results for H3B clinical programs.
Principal Duties and Responsibilities
- Biomarker sample logistics and clinical trial support
- Track the collection and shipment of biomarker clinical samples
from the clinical site to biobank and processing labs; working
closely with CROs/operations group to ensure all samples are
collected and shipped according to schedule.
- Coordinate shipments of samples to 3rd party laboratories for
testing; tracking and confirming samples are received by
- Work closely with clinical operations/CROs and/or clinical
sites to resolve sample related issues in a timely manner.
- Ensure documentation (laboratory manuals, informed consents,
biomarker management plans, analytical plans, and SOWs) is aligned
with the biomarker plan and project team goals.
- Contribute to the development of SOPs, as needed.
- Management of biomarker vendors and data
- In collaboration with cross-functional teams including the
biomarker lead, data science and data management, lead the
establishment and update of data transfer specifications to ensure
appropriate and consistent data transfer across H3B clinical
- Oversee and execute data quality control (QC) pipelines for
biomarker data such as next-generation sequencing, gene expression,
IHC and immunoassays
- Work closely with key vendors and CROs to support biomarker
sample collection and acquisition, laboratory services, sample
storage and/or biomarker analysis including defining scopes of
work, vendor management, and contract management in support of
study or research biomarker and CDx objectives and goals.
- Update and maintain study biomarker sample tracking
- BS/MS in a scientific discipline (biological sciences
preferred) with minimum 2 years experience, 5 years preferred,
leading biomarker operations for clinical studies.
- Outstanding organizational skills and capacity to prioritize
- Excellent people skills with ability to efficiently interface
with multiple groups including clinical operations, data sciences
and external CROs.
- Prior experience with biomarker data management and
implementation and use of sample management software is highly
About H3 Biomedicine Inc.H3 Biomedicine Inc. is a privately-held,
uniquely-structured oncology discovery enterprise whose sole
mission is to become a prolific source of new drugs that treat more
human cancers with greater success. H3 Biomedicine is applying the
expertise of leading scientists to the integration of insights from
cancer genomics with innovative capabilities in synthetic chemistry
and tumor biology to pursue the most promising current opportunity
in cancer therapeutics: patient-based, genomics-driven, small
molecule drugs. Submit Your Resumeby Jobble
Keywords: H3 Biomedicine, Cambridge , Biomarker Operations Associate, Other , Cambridge, Massachusetts
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