Senior Director, Clinical Operations – Rare Disease Gene Therapy
Location: Remote with occasional travel as needed
Overview:
On an exclusive assignment with our client, a leading biotechnology company advancing rare disease gene therapies, we seek a Senior Director of Clinical Operations.
This role involves strategic oversight of clinical trials, team leadership, and operational excellence to drive innovative therapies to regulatory approval.
Key Responsibilities:
* Lead complex early-phase clinical trials in rare diseases and neuroscience gene therapy, ensuring compliance with regulatory standards.
* Provide strategic oversight for clinical operations, including trial design, execution, timelines, budgets, and vendor management.
* Contribute to regulatory submissions (e.g., INDs, NDAs) and represent the client in regulatory agency meetings.
* Build and mentor a high-performing clinical operations team, fostering a culture of collaboration and excellence.
* Engage with KOLs, investigators, and external collaborators.
Qualifications:
* Advanced degree (MD, PhD, or equivalent) in a relevant scientific discipline.
* 15+ years of experience in drug development, including recent work in rare diseases and gene therapy.
* Proven track record managing complex early-phase trials
* 13+ years of experience managing multidisciplinary teams in a matrix environment.
* Deep knowledge of clinical trial design, GCP, regulatory requirements, and biostatistics.
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rare disease, clinical, operations, gene therapy, paediatric,