Role Overview for VP, Clinical Operations with a Rare Disease Firm – San Diego, CA
JRG Partners is proud to represent a pioneering, patient-centric biotechnology firm based in the vibrant life sciences hub of San Diego, CA. Our client is exclusively focused on developing and delivering transformative therapies for individuals and families affected by rare and ultra-rare diseases. With a robust pipeline and a deeply ingrained mission, they are seeking a visionary and execution-oriented Vice President (VP) of Clinical Operations to join their executive leadership team. This is a career-defining opportunity to build and lead a world-class clinical operations function, directly shaping the future of therapeutic development in an area of immense unmet medical need.
The VP of Clinical Operations will be the strategic architect and hands-on leader responsible for the oversight, planning, and execution of all clinical trial activities across the company’s portfolio. This role requires a dynamic leader who can seamlessly transition between high-level strategy and detailed operational execution. You will be instrumental in translating scientific objectives into actionable clinical development plans, ensuring trials are conducted on time, within budget, and in strict adherence to the highest ethical and regulatory standards.
Reporting directly to the Chief Medical Officer, you will foster a culture of excellence, innovation, and urgency, empowering a growing team of clinical operations professionals. Your leadership will be pivotal in navigating the complexities of rare disease trials, including challenges related to small patient populations, global site management, and novel endpoint development. If you are a passionate clinical operations expert with a proven track record in the rare disease space and a desire to make a tangible impact on patients’ lives, we invite you to consider this exceptional role.
Key Responsibilities of VP, Clinical Operations with a Rare Disease Firm – San Diego, CA
Strategic Leadership & Planning
Develop and implement the long-term strategic vision for the Clinical Operations department, ensuring full alignment with corporate goals and the overall clinical development plan. Provide expert operational input into the design and feasibility of clinical trial protocols.
Trial Execution & Oversight
Assume ultimate accountability for the successful execution of all clinical trials (Phase I-IV) across the portfolio, from start-up and enrollment through to study close-out and database lock. Proactively identify and mitigate risks to trial timelines, budgets, and data quality.
Team Development & Management
Lead, mentor, and expand a high-performing team of clinical operations professionals, including Clinical Trial Managers, CRAs, and Clinical Project Associates. Foster a collaborative, accountable, and patient-focused team culture.
Vendor & CRO Management
Oversee the selection, management, and performance of Contract Research Organizations (CROs), central labs, and other clinical trial vendors. Establish and monitor key performance indicators (KPIs) to ensure vendor accountability and high-quality deliverables.
Budget & Resource Management
Develop and manage the comprehensive clinical operations budget, including trial-specific costs and departmental overhead. Ensure meticulous financial forecasting, tracking, and reporting to senior management. Allocate resources effectively to meet competing priorities.
Regulatory Compliance
Guarantee that all clinical trial activities are conducted in full compliance with international regulations, including Good Clinical Practice (GCP), ICH guidelines, and other applicable regulatory requirements from the FDA, EMA, and other global health authorities.
Process Improvement & Innovation
Drive the development and implementation of scalable systems, processes, and Standard Operating Procedures (SOPs) to enhance efficiency, quality, and consistency within the clinical operations function. Champion the adoption of new technologies and innovative trial methodologies suitable for rare disease research.
Cross-Functional Collaboration
Serve as a key liaison and collaborative partner to other functional areas, including Clinical Development, Regulatory Affairs, Biometrics, Quality Assurance, and Program Management. Ensure seamless communication and integration of activities to achieve program milestones.
Study Documentation & Reporting
Oversee the Trial Master File (TMF) management to ensure all documentation is complete, accurate, and inspection-ready. Contribute to the preparation of key regulatory documents, including INDs, NDAs, and annual reports.
Stakeholder Engagement
Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and patient advocacy groups to support trial enrollment and ensure study designs are patient-centric and operationally viable.
Requirements for the VP, Clinical Operations with a Rare Disease Firm – San Diego, CA
Educational Background
An advanced degree (MS, PhD, PharmD, MD) in a life science 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. At least 7-10 years of experience in a leadership role with direct management responsibility for a clinical operations team.
Rare Disease Expertise
Demonstrable, in-depth experience managing clinical trials in rare diseases or orphan indications is a mandatory requirement. Understanding of the unique challenges and strategies associated with these programs is critical.
Global Trial Management
Proven track record of successfully managing multi-center, global clinical trials, including experience with regulatory submissions and inspections in key regions (e.g., North America, Europe).
Regulatory Acumen
Deep and current knowledge of GCP, ICH guidelines, and global regulatory requirements. Experience interacting directly with health authorities (e.g., FDA, EMA) is highly desirable.
Vendor Oversight
Extensive experience in selecting, negotiating with, and managing CROs and other clinical trial vendors to ensure performance and quality.
Financial Management
Strong financial acumen with experience developing and managing multi-million dollar clinical program budgets.
Leadership Skills
Exceptional leadership, mentoring, and team-building skills. Ability to inspire and motivate a team to achieve ambitious goals in a fast-paced environment.
Strategic Thinking
Proven ability to think strategically, anticipate future trends and challenges, and develop proactive solutions.
Communication & Interpersonal Skills
Outstanding verbal and written communication skills. Ability to effectively present complex information and influence stakeholders at all levels, from the project team to the Board of Directors.
Location
Ability to work on-site at the company’s headquarters in San Diego, CA. Relocation assistance is available for the ideal candidate.
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:
Competitive Base Salary
An attractive base salary commensurate with executive-level experience and impact.
Performance-Based Bonus
A generous annual bonus program tied to individual and company performance.
Equity Participation
A significant equity stake (stock options/RSUs) to ensure you share in the long-term success of the company.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance for you and your dependents.
Retirement Savings
A 401(k) plan with a strong company match.
Generous Paid Time Off
A flexible and generous PTO policy, including vacation, sick leave, and company holidays.
Professional Development
Support for continuing education, conference attendance, and professional growth.
Relocation Assistance
A comprehensive relocation package for qualified candidates moving to the San Diego area.
Wellness Programs
A variety of programs and perks to support employee health and well-being.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. To be considered for this pivotal leadership role, please submit your resume and a cover letter detailing your specific experience in rare disease clinical operations. We encourage all qualified and passionate individuals to apply. For more information about our expertise in this sector, please visit the JRG Partners’ Life Sciences practice area page. We look forward to reviewing your application and discussing this exciting opportunity with you.
