Clinical Diagnostics Associate

Clinical Diagnostics Associate

San Diego, California, United States

Clinical Diagnostics Associate

The Clinical Diagnostics Associate will provide project oversight, support, and program management for biomarker and diagnostic projects for the precision oncology pipeline. This position will collaborate with both external biomarker and diagnostic testing providers and internal clinical development and clinical operations teams in a small fast-paced, dynamic work environment. They will assist in managing the development, outsourcing, and validation of clinically applicable biomarker testing and diagnostic assays.

Essential Job Functions:

• Manage biospecimen sample sourcing for internal Translational Medicine projects, external biomarker testing, and Companion Diagnostics analytical validation. Utilize technical and clinical insights to source the appropriate biospecimens for assay validation activities.
• Work with external vendors and service providers on contracting and monitoring of assay development and sample testing projects, including financial transactions between company and them.
• Track project progress and proactively evaluate potential delays and adverse situations and escalate them to the manager immediately.
• Support the biomarker testing and companion diagnostic strategies in accordance with the requirements of quality, ethical, and regulatory standards, including ICH/GDPR/GCP/GLP.
• Support Companion Diagnostic partnership requests and actively participate in Joint Project Team calls. Ensure that the meeting minutes are captured appropriately, including all action items.
• Support Clinical Operations on the lifecycle of patient samples for biomarker testing and diagnostic technology development, including sample procurement from commercial sources (biobanks and biorepositories), sample collection at study sites, processing, storage, transfer to central lab, shipment to vendors for testing, analysis, input on relevant documentation, and final sample disposition (including long-term storage), while maximizing sample quality based on biomarker testing and diagnostics sample requirements. Be the point person to support Clinical Operations requests and obtain technical and regulatory input from other Diagnostic Team members when needed.
• Utilize available internal and external tracking systems to monitor and report progress, address issues, and ensure resolutions relating to samples that will be used for biomarker testing and diagnostics. Ensure that all risks related to biomarker testing and diagnostic technologies are accurately captured for the Project Management Team.
• Support data transfer agreements (DTAs) and monitor and report progress, address issues and ensure resolutions relating to biomarker testing and diagnostic data transfers. Be the point person for Data Management Team.
• Address questions from the program teams on biomarker testing and companion diagnostic vendors regarding sample collection, handling, transfer, testing, storage, etc. for all biomarker testing and companion diagnostics projects.
• Support Diagnostics Team on contracts, budgets, project, and development timelines and work closely with the Finance and Project Management Team to ensure that information is accurately captured.
• Invite and process work proposals for diagnostic projects and biomarker testing. Be the point person for obtaining proposals, work orders, statements of works, etc. from diagnostic and biomarker testing vendors based on the technical and regulatory needs related to the testing.
• Provide support for all activities involving start-up execution and close-out of all contracts, budgets, and timelines.
• Bring issues to Manager or Program team's as necessary and participate in the resolution of delays or potential delays.
• Manage Diagnostics team meetings as well as minutes, agendas, action items, etc. Prepare PowerPoints summarizing progress for Senior Leadership.
• Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical or commercial).

Job Requirements:

• BS, MS, in Biochemistry, Biology, Medical Technology, immunology, pharmacy, or related pharmaceutical science.
• 2-4 years of work experience in drug development, diagnostics, or clinical trial management.
• Experience with Microsoft Office, including Excel, required. Experience with Microsoft Project as well as other database and timeline management software preferred but not essential.
• Assay development experience preferred.
• High level of integrity, accuracy, and attention to detail.
• Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
• Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
• Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
• Outstanding interpersonal, communication, and negotiation skills.