Job Summary:

The Director of Clinical Operations will lead and oversee the execution of clinical trials focused on gene therapy, ensuring all operational aspects are aligned with the strategic goals of the organization. This role requires a deep understanding of clinical development, gene therapy technologies, regulatory requirements, and operational best practices. The Director will collaborate with cross-functional teams, manage clinical trial timelines, budgets, and resources, and drive the successful execution of clinical studies from Phase I through commercialization. The ideal candidate will thrive in a dynamic biotech environment, demonstrate a positive, solutions-oriented attitude, and possess a strong commitment to advancing gene therapy treatments.

Key Responsibilities:

• Lead the planning, execution, and monitoring of gene therapy clinical trials, ensuring adherence to timelines, budgets, and quality standards.
• Develop and implement clinical trial strategies and operational plans in alignment with company objectives.
• Oversee the management of clinical research sites, CROs, and vendors to ensure efficient trial conduct and compliance with regulatory guidelines.
• Collaborate with regulatory, medical, and clinical development teams to ensure the integration of key scientific and clinical insights into trial design.
• Ensure compliance with GxP, ICH, FDA, and other regulatory requirements in clinical trial operations.
• Provide leadership and mentorship to the clinical operations team, ensuring effective team development and knowledge transfer.
• Report on trial progress, risks, and milestones to senior leadership and stakeholders.
• Contribute to a positive, collaborative work environment and adapt to changing needs within a fast-paced biotech company.

Qualifications:

• Advanced degree (MD, PhD, or equivalent) in a relevant field, with a focus on gene therapy or related therapeutic areas.
• Extensive experience in clinical operations, with at least 5-7 years in leadership roles within gene therapy or biologics clinical trials.
• Strong understanding of gene therapy technologies, clinical development processes, and regulatory frameworks.
• Proven track record of successfully managing complex, multi-site clinical trials.
• Exceptional leadership, communication, and project management skills.
• Ability to thrive in a fast-paced, dynamic biotech environment with a positive and proactive attitude.
• Additional training or expertise in data processing or analytics is an advantage.