Job Title: Associate Director of Clinical Operations

Company Overview: Our client is a dynamic and innovative small biotech company dedicated to advancing breakthrough therapies in cell and gene therapy. We pride ourselves on our commitment to pushing the boundaries of medical science to improve patient outcomes. As we continue to grow, we are seeking a highly motivated and experienced individual to join our team as the Associate Director of Clinical Operations.

Position Overview: The Associate Director of Clinical Operations will play a crucial role in overseeing and managing the clinical trial operations for our diverse portfolio of investigational products, particularly in cell and gene therapy. This position requires a strategic and hands-on leader with a proven track record in clinical development, project management, and team collaboration. The successful candidate will contribute to the advancement of our clinical programs while ensuring compliance with regulatory standards and industry best practices.

Key Responsibilities:

1. Clinical Trial Oversight:

   • Provide leadership and strategic direction for the planning, implementation, and execution of clinical trials in cell and gene therapy from Phase I through Phase III.
   • Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure alignment of clinical operations with overall development goals.

2. Project Management:

   • Develop and manage project timelines, budgets, and resources to ensure timely and successful completion of clinical trials.
   • Identify potential risks and proactively implement mitigation strategies to keep projects on track.

3. Vendor Management:

   • 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.
   • Ensure vendors meet quality standards and deliverables in accordance with project timelines.

4. Regulatory Compliance:

   • Work closely with regulatory affairs to ensure clinical trial activities in cell and gene therapy adhere to applicable regulations and guidelines.
   • Support the preparation and submission of regulatory documents as needed.

5. Team Leadership and Development:

   • Lead and mentor a team of clinical operations professionals, fostering a collaborative and high-performance culture.
   • Provide guidance and training to team members to enhance their skills and capabilities.

Qualifications:

• Advanced degree in a relevant scientific discipline (e.g., life sciences, pharmacy, nursing).
• Minimum of 10 years of experience in clinical operations within the biopharmaceutical industry, with a focus on cell and gene therapy.
• Demonstrated success in leading and managing clinical trials in cell and gene therapy from initiation to completion.
• Strong understanding of regulatory requirements and GCP guidelines in the context of cell and gene therapy.
• Excellent project management and organizational skills.
• Effective communication and leadership abilities.
• Experience working in a small biotech environment is preferred.

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