Senior Clinical Operations Manager
3 weeks ago
A2 Biotherapeutics, Inc. is a clinical-stage biotech company dedicated to developing innovative logic-gated cell therapies for cancer treatment. Our proprietary TmodTM cell therapy platform addresses the fundamental challenge in cancer treatment—distinguishing between tumor and normal cells.
We have three Investigational New Drugs (INDs) in first-in-human clinical stage personalized cell therapy studies: EVEREST-1, EVEREST-2, and DENALI-1. We also conduct pre-screening studies like BASECAMP-1 to identify patients suitable for our Auto and Allogeneic Tmod cell therapy studies. For more information, visit our website at www.a2bio.com.
Clinical Operations Senior Manager Job OverviewThis role oversees clinical trials sponsored by A2 Biotherapeutics, supporting the growth and development of the Clinical Operations department. The ideal candidate will lead all aspects of clinical trial conduct, including study start-up, enrollment, maintenance, and close-out. This position is located in Agoura Hills, CA.
Key Responsibilities:- Oversight of operational aspects of assigned clinical trials, ensuring timely delivery within budget and quality standards.
- Management of internal functions (e.g., direct reports, cross-functional teams) and external partnerships (e.g., CROs, vendors, clinical investigators).
- Development, review, and approval of clinical documents, such as protocols, informed consent forms, and safety management plans.
- Liaison with vendors, contractors, and sites, providing training and support as needed.
- Identification and mitigation of potential study risks and issues.
- 3+ years of experience in clinical operations, preferably in oncology and/or cell therapy space.
- Strong understanding of ICH guidelines, GxPs, FDA, and EMA regulations.
- Excellent communication, analytical, and problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced environment.
This position offers a competitive base salary ($150,000 - $180,000 annually) and annual incentive opportunities. Benefits include medical, dental, and vision coverage, life, disability, and accident insurance, health and wellness programs, paid time off, holidays, flexible work arrangements, paid parental leave, and professional development support.
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