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Clinical Operations Senior Manager

1 month ago

Agoura, California, United States A2 Biotherapeutics Full time
Cell Therapy Clinical Trial Operations Lead

A2 Biotherapeutics, Inc. is a pioneering biotech company developing innovative cell therapy solutions to combat cancer.

We are seeking an experienced Clinical Operations Senior Manager to lead our clinical trial operations team in the development of first-in-class logic-gated cell therapies.

This individual will be responsible for overseeing all aspects of clinical trial conduct, including study start-up, enrollment, maintenance, and close-out. The successful candidate will work closely with cross-functional teams to ensure timely and cost-effective delivery of high-quality clinical trials.

The ideal candidate will have a strong background in cell therapy clinical trial operations, excellent communication and interpersonal skills, and experience managing CROs and other vendors.

Responsibilities:

  • Oversight of all operational aspects of assigned clinical trials, including study start-up, enrollment, maintenance, and close-out.
  • Management of internal and external functions to ensure timely delivery of clinical operations deliverables within budget and quality standards.
  • Development and tracking of study timelines, budgets, metrics, and milestones.
  • Collaboration with cross-functional teams to identify potential issues and develop mitigation plans.
  • Leadership of internal study team meetings and working group meetings.
  • Management of vendor selection and performance tracking.
  • Training and support for internal study teams, vendors, and sites.

Requirements:

  • Experience in cell therapy clinical trial operations, preferably in oncology and/or cell therapy space.
  • Strong analytical and problem-solving skills, with ability to communicate risks and mitigation plans.
  • Excellent interpersonal and written communication skills.
  • Strong clinical research knowledge and understanding of ICH guidelines, GxPs, and FDA/EMA regulations.
  • Ability to work independently and collaboratively as part of a team.
  • Bachelor's degree in life sciences or related field, plus 5 years of direct experience in clinical operations.

Benefits:

  • Competitive base salary ($150,000 - $180,000) and annual incentive opportunities.
  • Equity participation.
  • Medical, dental, and vision benefits.
  • Life, disability, and accident coverage.
  • Health and wellness programs.
  • Paid time off and holidays.
  • Flexible work arrangements.
  • Paid parental leave.