Location: Cambridge MA
Cambridge, 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 H3B’s 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 vendors.
- 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 programs.
- 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 system(s).
- 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 multiple tasks
- 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 desirable.
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.