Role Overview for VP, Clinical Research Operations with an Oncology Biotech – San Diego, CA
JRG Partners is proud to represent a pioneering, clinical-stage oncology biotechnology company in their exclusive search for a Vice President of Clinical Research Operations. Based in the vibrant biotech hub of San Diego, CA, this is a career-defining opportunity for a visionary leader to shape the future of cancer therapy. Our client is at the forefront of developing next-generation treatments, and this pivotal role will provide the strategic and operational leadership necessary to advance their promising pipeline through clinical development and towards regulatory approval.
As the VP of Clinical Research Operations, you will be the primary architect and driver of the company’s clinical trial execution strategy. Reporting directly to the Chief Medical Officer (CMO), you will hold ultimate accountability for the operational excellence, quality, and timely delivery of all clinical programs. This role requires a dynamic individual who can seamlessly blend high-level strategic planning with hands-on operational oversight. You will lead, mentor, and expand a world-class clinical operations team, fostering a culture of innovation, collaboration, and unwavering commitment to patient safety and data integrity. This executive will be instrumental in building the necessary infrastructure, processes, and systems to support the company’s growth from a clinical-stage entity to a commercial organization. If you are a seasoned clinical operations expert with a deep passion for oncology and a proven track record of bringing novel therapies to patients, we invite you to explore this exceptional opportunity.
Key Responsibilities of VP, Clinical Research Operations with an Oncology Biotech – San Diego, CA
The Vice President of Clinical Research Operations will be responsible for the full spectrum of clinical trial management, from strategic planning to final study reporting. Key responsibilities include:
Strategic Leadership & Planning
Collaborate with executive leadership to develop and implement the long-range clinical development strategy. Translate corporate goals into actionable clinical operations plans, ensuring alignment across all functions. Provide expert operational input into clinical development plans (CDPs), study protocols, and program timelines.
Operational Excellence & Execution
Assume full accountability for the planning, execution, and oversight of all clinical trials (Phase I-IV), ensuring they are completed on time, within budget, and in strict adherence to quality standards. Proactively identify and mitigate risks to trial timelines, budgets, and objectives. Drive the implementation of innovative technologies and best practices to enhance trial efficiency and data quality.
Team Leadership & Development
Build, lead, mentor, and retain a high-performing global clinical operations team, including Clinical Trial Managers, Clinical Research Associates, and support staff. Foster a positive, collaborative, and results-oriented culture. Establish clear performance goals and provide ongoing coaching and professional development opportunities for team members.
Vendor and Site Management
Lead the selection, qualification, and management of Contract Research Organizations (CROs), central laboratories, and other clinical trial vendors. Negotiate contracts and budgets, and ensure vendors meet performance and quality expectations. Cultivate and maintain strong relationships with key opinion leaders (KOLs), investigators, and clinical trial sites to ensure optimal site performance and engagement.
Regulatory Compliance & Quality Assurance
Ensure all clinical trial activities are conducted in full compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements. Oversee the development and maintenance of Standard Operating Procedures (SOPs) for the clinical operations department. Prepare the organization for and lead regulatory inspections (e.g., FDA, EMA).
Financial & Resource Management
Develop, manage, and forecast the comprehensive clinical operations budget. Oversee resource planning and allocation to ensure all programs are adequately supported. Drive cost-efficiency without compromising quality or compliance. Provide regular updates to the executive team on budget performance and financial outlook.
Cross-Functional Collaboration
Serve as a key liaison between Clinical Operations and other critical functions, including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and CMC. Ensure seamless communication and integration of activities to achieve program milestones.
Requirements for the VP, Clinical Research Operations with an Oncology Biotech – San Diego, CA
The ideal candidate will be a strategic and execution-focused leader with extensive experience in the oncology biotech space. Specific qualifications include:
Education
An advanced degree (MS, PhD, PharmD, or equivalent) in a life sciences or health-related field is required.
Experience
- A minimum of 15 years of progressive experience in clinical operations within the biotechnology or pharmaceutical industry.
- At least 10 years of direct experience managing oncology clinical trials is mandatory. Experience with cell therapy, biologics, or small molecules is highly desirable.
- A proven track record of successfully leading clinical operations for early-stage (Phase I/II) through late-stage (Phase III) development programs and supporting regulatory submissions (IND, NDA/BLA).
- Minimum of 8 years of direct line management experience, with demonstrated success in building and leading high-performing teams in a fast-paced environment.
- Extensive experience in the selection, oversight, and management of CROs and other clinical vendors on a global scale.
- Direct experience preparing for and participating in successful regulatory authority inspections.
Skills & Competencies
- Expert knowledge of drug development, clinical trial design, and global regulatory landscapes (FDA, EMA, etc.).
- Exceptional leadership, influencing, and interpersonal skills with the ability to build strong relationships with both internal and external stakeholders.
- Outstanding strategic thinking and problem-solving abilities, with a knack for identifying potential issues and implementing effective solutions.
- Excellent written and verbal communication skills, with the ability to present complex information clearly to diverse audiences.
- Strong financial acumen, with proven experience in developing and managing large, complex budgets.
- A high degree of personal integrity, a strong sense of urgency, and a passion for bringing life-changing therapies to cancer patients.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, including:
Competitive Compensation
A highly attractive base salary and an annual performance-based bonus.
Meaningful Equity
A significant stock option package, providing a tangible stake in the company’s long-term success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A flexible and generous Paid Time Off (PTO) policy, supplemented by company holidays.
Professional Growth
A dedicated budget for professional development, including conferences, workshops, and continuing education.
Relocation Support
A comprehensive relocation package is available for exceptional candidates.
Inspiring Work Environment
A dynamic, collaborative, and science-driven culture located in the heart of San Diego’s biotech community.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. To be considered for this transformative leadership opportunity, please submit your resume and a cover letter outlining your qualifications and interest in the role. We are committed to a prompt and confidential review of all applications. For more career-defining opportunities within our specialized sectors, we invite you to explore our Life Sciences and Biotechnology Practice Area page.
