Associate Director, Biomarker Operations
3 weeks ago
Reporting to the VP, Clinical Operations, the **Associate Director, Biomarker Operations **is responsible for understanding the scientific strategy and implementation of biomarker assays to support clinical programs. This is a leadership position that has extensive experience in the following areas: Biomarker/Diagnostic Assay Development and Analysis Expertise, Clinical Trial Operations, Procedures and Regulations, Biospecimen Management, Vendor Sourcing & Contracting, Informed Consent (ICF) Design & Interpretation, Central and Specialty Lab Testing and Management. The Associate Director of Biomarker Operations is also a key contributor to clearly define protocol requirements. This individual identifies, understands, and translates the scientific testing needs from a protocol to a laboratory SOW. This individual establishes cross-functional relationships to clearly understand protocol strategy to successfully execute on clinical trials, operational improvement, and change initiatives that impact biomarker assays performed by either central or specialty laboratories. This individual is responsible for working with the Study Operations, Procurement, Business Operations, Clinical and Translational Medicine, Clinical Data Management, Legal, GCP Compliance, Quality, and Research teams to ensure a smooth process flow for all biomarker-related activities.
- The role is fully based in San Carlos, CA._
**WHAT YOU’LL DO AT CARGO THERAPEUTICS**- Provides biomarker and diagnostic project management and operations leadership across multiple clinical programs after Research & Early Development colleagues define the scientific path forward- Leads project initiatives and team meetings- Develops the organization’s SOPs and implement best practice documents as appropriate- Supports the implementation and execution of the clinical biomarker and diagnostic strategy with central and specialty laboratories in early and late development programs once defined by Clinical Development Team- Manages key biomarker timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout- Works effectively with procurement and scientific leads for vendor sourcing and selection process for new or existing central and specialty labs- Executes contracts and statements of work to meet program deliverables- Contributes to central lab setup and management throughout the course of a study- Participates in virtual and in-person operational visits, when scheduled- Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed and tested, and data is reported to meet development timelines and specifications- Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs- Contributes to the preparation of clinical documents such as clinical protocols, clinical study reports, lab manuals, informed consent forms, sample management plans, early development plans, and site training materials- Works with scientific stakeholders to identify innovative biospecimen collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards- Collaborates with Clinical Development for on site trainings for biomarker sample management logistics, sample and testing questions from sites, IRBs, and ethics committees- Develops, with cross-functional staff, presentations and presents biospecimen tracking/testing metrics at regular team meetings- May work with scientific stakeholders to evaluate and implement new assays and relevant technology as required to meet clinical program timelines- Manages relationships with internal and external partners to ensure on time and quality deliverables- Mentors biomarker/biospecimen operations staff to ensure consistency and high standards across the organization- Provides guidance and/or acts as a primary point of contact for escalation for central and specialty laboratories addressing any biomarker operational questions/issues that may arise and liaises with individual or cross-functional teams for resolution- Reviews and escalates, when necessary, unresolved operational issues to JOC and/or EOC Chair and other cross-functional teams, as needed- Participates in Study Management Team (SMT) and other cross functional meetings as a member throughout the life cycle of a clinical trial to provide input, if needed- Identifies, develops, and implements risk mitigation strategies as needed across programs- Point of contact with research colleagues who have questions about availability and suitability for future research use of residual clinical biospecimens- Participates in inquiries related to the appropriateness or integrity of biospecimens, work with stewards on disposal requests as appropriate
**THE RIGHT STUFF: Required Experience & Qualifications**- Life Science degree in scientific, medical or healthcare area- MS, PhD, and/or pr
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