Clinical Operations Director
2 days ago
Artiva Biotherapeutics is seeking a highly experienced Sr. Director, Clinical Operations to join our team in San Diego. As a key member of our clinical operations team, you will be responsible for overseeing the execution of clinical trials, ensuring compliance with regulatory requirements, and driving operational excellence.
Key Responsibilities:- Develop and implement clinical trial operational plans, including timelines, budgets, and resource allocation.
- Manage vendor relationships, including CROs and clinical sites, to ensure timely and cost-effective execution of clinical trials.
- Oversee the preparation and submission of regulatory documents, including INDs and clinical study reports.
- Collaborate with cross-functional teams to ensure seamless execution of clinical trials, including clinical research, regulatory, and quality assurance.
- Develop and maintain clinical operations SOPs and guidelines to ensure compliance with regulatory requirements.
- Provide leadership and guidance to clinical operations team members to ensure operational excellence.
- Minimum 15 years of experience in clinical operations, including experience in CRO/vendor management and clinical trial execution.
- Proven knowledge and experience with ICH/GCP guidelines, FDA and EMA regulations, and clinical quality and regulatory standards.
- Experience in conducting international clinical studies, particularly in EU and Asia Pacific/Australasia countries.
- Autoimmune diseases and/or oncology experience is required, with cell therapy experience being a strong plus.
- Superior oral and written communication skills, with the ability to work effectively with senior management and cross-functional teams.
- Competitive salary range: $234,000 - $265,000.
- Opportunity to work with a cutting-edge biotechnology company focused on developing natural killer (NK) cell-based therapies.
- Collaborative and dynamic work environment with a team of experienced professionals.
Artiva Biotherapeutics is an equal employment opportunity employer. We are committed to diversity and inclusion in the workplace and encourage applications from qualified candidates of all backgrounds.
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