Strategic Director of Clinical Development Operations
3 weeks ago
We seek a highly skilled and experienced Strategic Director of Clinical Development Operations to join our team at Barrington James Limited. This role will be responsible for leading the planning, implementation, and execution of clinical trials in cell and gene therapy from Phase I through Phase III, ensuring alignment of clinical operations with overall development goals.
Key Responsibilities:
- Provide leadership and strategic direction for the planning, implementation, and execution of clinical trials in cell and gene therapy.
- Collaborate with cross-functional teams to ensure alignment of clinical operations with overall development goals.
- Develop and manage project timelines, budgets, and resources to ensure timely and successful completion of clinical trials.
- Select, negotiate contracts with, and manage relationships with clinical service providers, including CROs, central labs, and other vendors, with a focus on cell and gene therapy expertise.
- Work closely with regulatory affairs to ensure clinical trial activities in cell and gene therapy adhere to applicable regulations and guidelines.
Requirements:
- Advanced degree in a relevant scientific discipline.
- Strong understanding of regulatory requirements and GCP guidelines in the context of cell and gene therapy.
- Excellent project management and organizational skills.
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