Day One was founded to address a critical unmet need: children with cancer are being left behind in a cancer drug development revolution. Our name was inspired by the “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. We aim to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

SUMMARY: 

Day One Biopharmaceuticals is seeking a Biomarker Operations Specialist. This position will be responsible for working with translational and clinical research leads to manage implementation of preclinical studies and translational research components of clinical trials.

Regarding preclinical research, this individual will be responsible for managing inventory for research and development programs, including compounds and study tracking. On the clinical side, the Biomarker Operations Specialist will bring operational and strategic expertise to the clinical study team in order to ensure success in this critical aspect of our clinical trials. This includes responsibility for the planning, coordination, and maintenance of all operational activities for clinical biospecimen management, oversight of clinical sample shipment and reconciliation, tracking the execution of biomarker testing for early and late-stage clinical trials, and managing timelines and data transfer to align with the clinical trial schedule.

 Essential Duties and Responsibilities

• Support biomarker strategy within early and late stage clinical development programs

• Be responsible for aspects of biomarker development from conception to execution

• Work closely with research and clinical teams for successful implementation of biomarker plans and operations and oversee biospecimen sample management for clinical trials

• Oversee entire clinical trial biospecimen process from kit assembly to clinical sample collection, shipment receipt and tracking and process for clinical biospecimen biorepository and maintaining central documentation

• Manage patient sample analysis, reconciliation against study visits and data transfer

• Manage sample retention times according to trial informed consent parameters

• Adhere to ICH/GCP, HIPAA, biorepository, and biospecimen management best practices

• Support review of biomarker sections in protocols, kit development, lab manuals and consent forms

• Oversee clinical assay vendors, including vendor selection, contract execution and budget review and timelines

• Author biomarker relevant sections in clinical study documents and systems

• Provide sample and assay status updates to project team and help build and maintain dashboards and modern tracking systems

• Work collaboratively in cross-functional, fast-paced, regulatory-rich environment

Education/Experience/Skills

• Life sciences degree (BS or MS) in scientific or clinical discipline

• 5+ years of drug development in biopharmaceutical or biotech industry

• 3+ years’ experience in technical research, project management or clinical logistics role; experience in sample management preferred

• Experience in GLP, GMP and/or GCP regulated environments and studies

• Experience working with colleagues remotely

• Prior experience with vendor management is expected

• Experience and insight into basic, translational and clinical research related to biomarkers

• Experience managing CROs and consultants

• Excellent communication and presentation skills

• Excellent organization skills and ability to manage projects to meet key deliverables

• Ability to work independently and proactively

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.