Senior Director Of Clinical Operations

Overview

• Lead clinical trial management for Phase 1/2 programs in a dynamic biotech environment.
• Drive operational execution across clinical programs, ensuring compliance with regulatory standards.
• Collaborate with cross-functional teams to achieve program milestones and strategic goals.
• Manage vendor relationships, including contract negotiation and performance monitoring.
• Ensure readiness for regulatory submissions, leveraging BLA experience.
• Foster a culture of accountability and high-quality execution within the clinical operations team.
• Contribute to the development of innovative gene therapy solutions in a fast-paced environment.

Key Responsibilities & Duties

• Plan, execute, and close out global clinical trials from initiation to registrational studies.
• Oversee CROs and vendors, ensuring adherence to timelines and quality standards.
• Develop and implement risk-based quality oversight strategies for clinical trials.
• Prepare for regulatory submissions, including BLA/MAA readiness and TMF management.
• Mentor and build a lean clinical operations team to drive program success.
• Collaborate with clinical development, CMC, and regulatory teams on study designs.
• Monitor patient recruitment and data quality, ensuring compliance with GCP/ICH guidelines.

Job Requirements

• Bachelor’s degree in life sciences, nursing, or related field; MS/PhD preferred.
• 10+ years of clinical operations experience, with 5 years in CAR-T or gene therapy trials.
• Direct involvement in BLA submissions and health authority interactions.
• Proficiency in CTMS/eTMF systems, such as Veeva, is highly desirable.
• Experience in rare diseases, cardiovascular, or neurodegenerative indications is advantageous.
• Strong communication and presentation skills for diverse stakeholders.
• Ability to operate strategically and tactically in a matrixed organization.