We are seeking a dynamic and experienced remote Associate Director of Clinical Operations to lead the execution of a first-in-human clinical trial. This role will be responsible for strategic planning, site selection, patient recruitment, and vendor management, ensuring seamless trial operations. The ideal candidate has extensive experience in early-phase oncology trials (preferably immunotherapy) and a deep understanding of cell and gene therapy products. This individual will play a pivotal role in driving operational excellence, ensuring regulatory compliance, and contributing to the success of our clinical development programs.
Our client is a fast-growing, well-funded startup at the forefront of oncology drug development. As part of a small, collaborative team, you’ll play a key role in advancing first-in-human clinical trials for cutting-edge cell and gene therapies. With strong career growth potential, direct leadership exposure, and the chance to make a real impact, this is a unique opportunity to shape the future of cancer treatment.
Requirements of the Associate Director of Clinical Operations:
- 7-10 years of experience in clinical operations, including at least 5 years in oncology drug development.
- Strong preference for candidates with cell/gene therapy and immunotherapy experience.
- Proven ability to successfully lead early-phase clinical trials, preferably in a biotech environment.
- Expertise in clinical trial recruitment strategies, technologies, and vendor management.Deep understanding of FDA, EMA, ICH-GCP, and other global regulatory requirements.
- Extensive experience in selecting, negotiating, and managing CROs and clinical trial vendors.
Responsibilities of the Associate Director of Clinical Operations:
- Oversee the execution of a first-in-human AAV-based immunotherapy trial, ensuring adherence to regulatory, ethical, and GCP guidelines.
- Develop and manage clinical trial timelines, budgets, and operational plans, aligning them with corporate objectives.
- Identify, assess, and oversee CROs, clinical sites, and external vendors to optimize trial efficiency.
- Lead site selection, patient recruitment strategies, and clinical monitoring to ensure trial milestones are met.
- Contribute to the establishment of clinical SOPs, processes, and best practices to enhance operational efficiency.
Occupational Category: 11-9111.00 Medical and Health Services Managers
Application Instructions: Please apply using the form or send your resume to
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