Role Overview for VP, Clinical Research Operations with a Gene Therapy Company – San Diego, CA
JRG Partners is exclusively representing a pioneering, clinical-stage gene therapy company based in the vibrant biotech hub of San Diego, CA. Our client is at the forefront of developing potentially curative treatments for rare and life-threatening genetic diseases. With a robust pipeline and a commitment to scientific excellence, they are seeking a visionary and experienced Vice President of Clinical Research Operations to join their executive leadership team. This is a unique opportunity to shape the operational strategy and execution of clinical programs that have the potential to transform patients’ lives.
The Vice President, Clinical Research Operations will be a key strategic leader responsible for providing oversight and direction to all aspects of the company’s clinical trial activities. This executive will ensure that all clinical studies are conducted with the highest standards of quality, on schedule, and within budget, while in full compliance with global regulatory requirements. You will be responsible for building, leading, and mentoring a world-class clinical operations team capable of executing complex, global gene therapy trials. The ideal candidate will be a hands-on leader with a deep understanding of the intricacies of gene therapy development, a proven track record of operational excellence, and a passion for bringing groundbreaking therapies to patients in need. You will serve as the primary operational authority on the clinical development team, working in close collaboration with leaders across Clinical Development, Regulatory Affairs, Biostatistics, and Program Management to drive the company’s assets from early-phase development through to successful regulatory submission and commercialization. Your leadership will be instrumental in scaling the company’s operational capabilities and establishing the robust processes necessary for long-term success in a highly competitive and rapidly evolving field.
Key Responsibilities of VP, Clinical Research Operations with a Gene Therapy Company – San Diego, CA
Strategic Leadership and Planning
Develop and execute the long-term strategic vision for the Clinical Operations department, ensuring full alignment with the company’s overall corporate goals and clinical development plans (CDPs). Proactively identify and address operational risks, resource gaps, and strategic opportunities. Contribute significantly to the design and optimization of clinical trial protocols, focusing on operational feasibility and patient centricity.
Clinical Trial Execution and Oversight
Provide executive oversight for the planning, execution, and management of all clinical trials (Phase I-IV) across the portfolio. This includes accountability for site selection and activation, patient recruitment and retention strategies, data collection, and study close-out activities. Ensure trials are delivered on time, within budget, and with uncompromising quality.
Team Leadership and Development
Build, lead, mentor, and inspire a high-performing global Clinical Operations team. Foster a culture of accountability, collaboration, innovation, and urgency. Provide clear direction, set performance objectives, and support the professional growth and development of team members. Scale the team’s capabilities to meet the demands of a growing and complex clinical pipeline.
Vendor and CRO Management
Lead the selection, qualification, and management of Contract Research Organizations (CROs), central labs, and other clinical trial vendors. Establish and maintain strong, collaborative partnerships, set clear performance expectations, and ensure rigorous oversight of all outsourced activities to guarantee quality and timely delivery of services. Negotiate contracts and manage vendor budgets effectively.
Regulatory Compliance and Quality Assurance
Guarantee that all clinical trial activities are conducted in strict adherence to Good Clinical Practice (GCP), ICH guidelines, and global FDA regulations and other international regulatory standards. Oversee the development and implementation of robust Standard Operating Procedures (SOPs) for the clinical operations function. Prepare the team for and oversee regulatory agency inspections.
Financial and Resource Management
Develop, manage, and oversee the multi-million dollar annual clinical operations budget. Provide accurate forecasting, resource allocation, and financial reporting. Ensure fiscal responsibility and efficiency in all trial-related expenditures. Partner with finance to ensure alignment on long-range planning and budget cycles.
Cross-Functional Collaboration
Serve as a key member of the clinical development leadership team, fostering a highly collaborative environment with internal stakeholders. Work seamlessly with colleagues in Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, CMC, and Program Management to ensure integrated and efficient drug development. Communicate program status, risks, and milestones effectively to the executive team and board of directors.
Process Improvement and Innovation
Continuously evaluate and improve clinical operations processes, systems, and tools to enhance efficiency, quality, and scalability. Champion the adoption of new technologies and innovative approaches to clinical trial management to maintain a competitive edge and accelerate development timelines.
Requirements for the VP, Clinical Research Operations with a Gene Therapy Company – San Diego, CA
Educational Background
An advanced degree (MS, PhD, PharmD, or MD) in a life sciences or related field is strongly preferred. A Bachelor’s degree with extensive, directly relevant experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in clinical operations within the biopharmaceutical industry, with at least 10 years in a leadership role managing teams and directing clinical trial programs.
Gene Therapy / Rare Disease Expertise
Significant, hands-on experience in managing clinical trials for gene therapies, cell therapies, or in rare/orphan disease indications is a mandatory requirement. This expertise is critical for understanding the unique operational, logistical, and regulatory challenges associated with these advanced modalities.
Global Trial Management
Demonstrated success in leading and managing complex, multi-center, global clinical trials from initiation through to regulatory submission. Experience with BLA/MAA filings is highly desirable.
Regulatory Acumen
Expert knowledge of GCP, ICH guidelines, and global regulatory requirements (e.g., FDA, EMA). Proven experience in successfully preparing for and hosting regulatory inspections.
Leadership and Management Skills
Exceptional leadership capabilities with a proven ability to build, motivate, and develop high-performing teams in a fast-paced, dynamic environment. A strategic thinker who can also execute tactically.
Vendor Management Expertise
Extensive experience in the selection, negotiation, and management of CROs and other clinical vendors, with a track record of driving performance and quality.
Communication and Interpersonal Skills
Outstanding written and verbal communication skills. The ability to articulate complex concepts clearly and concisely to a variety of audiences, from scientific teams to executive leadership. Strong interpersonal skills with a demonstrated ability to build consensus and influence across functions.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
- A competitive base salary and an aggressive annual performance-based bonus.
- A significant equity stake in the company through stock options, providing a meaningful opportunity for wealth creation.
- Comprehensive health, dental, and vision insurance plans for you and your dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- A generous Paid Time Off (PTO) policy, including vacation, sick leave, and company holidays.
- Support for professional development, including attendance at conferences and continuing education opportunities.
- Relocation assistance for exceptional candidates who are not local to the San Diego area.
- The invaluable opportunity to work in a mission-driven, patient-focused culture with a team of passionate and brilliant colleagues dedicated to changing the course of medicine.
How to Apply
If you are a visionary clinical operations leader with a passion for advancing gene therapy and you meet the qualifications outlined above, we strongly encourage you to apply for this transformative opportunity. JRG Partners is proud to partner with this innovative company to find their next clinical operations leader. To be considered, please submit your resume and a cover letter detailing your relevant experience through our secure portal.
To explore other executive opportunities within this dynamic and growing sector, we invite you to visit the JRG Partners Life Sciences and Biotechnology Practice Area page. We look forward to connecting with you.
