Associate Director, Biomarker Operations - Cargo Therapeutics
San Carlos, CA
About the Job
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 project management certification desirable
- 3+ years of biomarker operations experience in a clinical development, project management, biomarker/diagnostic laboratory and/or pharmaceutical or biotech R&D
- Direct line management experience
- Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP, In Vitro Diagnostic Regulation (IVDR) 2017/746, General Data Protection Regulation (GDPR) required
- Excellent leadership and mentoring skills, with experience leading projects in a multi-function matrix environment
- Project management and/or program operations experience
- Knowledge of drug development and/or biomarker/diagnostic assay development and analysis
- Ability to effectively and collaboratively work on global cross-functional teams
- Excellent written and verbal communication skills
PAY RANGE
The pay range for this role is $152,000 - $209,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.
Join us to help make a difference!
EEO & EMPLOYMENT ELIGIBILITY
CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Source : Cargo Therapeutics