Role Overview for VP, Clinical Operations with an Oncology Biotech – San Diego, CA
JRG Partners is proud to represent a pioneering, clinical-stage oncology biotechnology company based in the vibrant life sciences hub of San Diego, CA. Our client is dedicated to developing next-generation therapeutics that address significant unmet needs in cancer treatment. With a robust pipeline of innovative assets and a culture of scientific excellence, they are poised for significant growth and impact. We are seeking a visionary and highly experienced Vice President of Clinical Operations to join their executive leadership team.
This is a transformative opportunity for a strategic leader to assume ultimate responsibility for the planning, execution, and oversight of all clinical trial activities. Reporting directly to the Chief Medical Officer (CMO), the VP of Clinical Operations will be a pivotal figure in advancing the company’s portfolio from early-phase development through to potential regulatory approval and commercialization. You will provide the leadership, strategic direction, and operational expertise necessary to build and scale a world-class clinical operations function.
The ideal candidate is a seasoned professional with a deep understanding of the complexities of global oncology trials. You are not just an operator but a strategic thinker who can anticipate challenges, develop innovative solutions, and inspire a team to achieve ambitious goals. You will be instrumental in shaping the company’s clinical development strategy, ensuring trials are conducted with the highest standards of quality, compliance, and efficiency. This role requires a hands-on leader who can thrive in a dynamic, fast-paced biotech environment and is passionate about making a tangible difference in the lives of patients with cancer.
Key Responsibilities of VP, Clinical Operations with an Oncology Biotech – San Diego, CA
The Vice President of Clinical Operations will have a broad range of responsibilities, encompassing strategic leadership, operational execution, team development, and financial stewardship. Success in this role will be defined by the ability to deliver high-quality clinical trial data on time and within budget, enabling key corporate milestones.
Strategic Leadership & Planning
- In partnership with the CMO and other executive leaders, develop and implement long-range clinical development plans (CDPs) that align with corporate strategy.
- Provide strategic operational input into the design of clinical trial protocols, ensuring they are scientifically sound, operationally feasible, and meet regulatory requirements.
- Establish and drive the overall vision for the Clinical Operations department, fostering a culture of accountability, innovation, and excellence.
- Proactively identify and mitigate risks to clinical trial timelines, budgets, and quality through comprehensive risk management planning.
- Represent the Clinical Operations function in high-level corporate discussions, board meetings, and interactions with external partners and investors.
Operational Excellence & Trial Execution
- Assume full accountability for the execution of all clinical trials (Phase I-IV) across the oncology portfolio, ensuring they are conducted in accordance with the protocol and timelines.
- Oversee the development and implementation of robust Standard Operating Procedures (SOPs) for the clinical operations department.
- Ensure all clinical trial activities are conducted in strict adherence to international standards, including ICH E6 (R2) Good Clinical Practice (GCP) guidelines, and other applicable global regulatory requirements.
- Lead the selection, qualification, and management of Contract Research Organizations (CROs), central labs, and other clinical vendors, ensuring performance meets contractual obligations and quality standards.
- Drive the implementation of cutting-edge technologies and systems (e.g., CTMS, eTMF, EDC) to enhance trial efficiency, data quality, and oversight.
- Chair internal and joint clinical operations meetings to monitor trial progress, address challenges, and ensure cross-functional alignment.
Team Leadership & Development
- Build, lead, and mentor a high-performing Clinical Operations team, including Clinical Trial Managers, CRAs, and Clinical Project Associates.
- Champion a culture of continuous improvement, professional development, and collaborative teamwork.
- Establish clear performance goals and metrics for the department and individual team members, providing regular feedback and coaching.
- Effectively manage resource allocation and departmental headcount to support the growing clinical pipeline.
- Foster a positive and inclusive work environment that attracts and retains top talent in the industry.
Financial & Cross-Functional Management
- Develop, manage, and forecast the overall clinical operations budget, ensuring fiscal responsibility and accurate reporting of variances.
- Collaborate seamlessly with other key functions, including Clinical Development, Regulatory Affairs, Quality Assurance, Biostatistics, Data Management, and Finance, to ensure integrated and successful program execution.
- Play a key role in the preparation of regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and briefing documents.
Requirements for the VP, Clinical Operations with an Oncology Biotech – San Diego, CA
We are seeking a candidate who meets the following qualifications to lead our client’s clinical operations team to success.
Required Qualifications:
- An advanced degree (MS, PhD, or PharmD) in a life sciences or related field is required.
- A minimum of 15 years of progressive experience in clinical operations within the biotechnology or pharmaceutical industry.
- At least 10 years of direct line management and leadership experience, with a proven track record of building and developing successful teams.
- Extensive and deep experience in oncology clinical trials is mandatory; experience with both solid tumors and hematologic malignancies is highly desirable.
- Demonstrated experience managing the full lifecycle of clinical trials, from first-in-human (Phase I) through to pivotal registration studies (Phase III).
- Expert knowledge of FDA regulations, ICH/GCP guidelines, and other international regulatory requirements.
- Proven experience in the selection and management of CROs and other clinical trial vendors, including contract negotiation and performance oversight.
- Strong financial acumen with experience developing and managing multi-million dollar clinical program budgets.
Preferred Qualifications & Attributes:
- Experience with global clinical trials, including studies conducted in North America, Europe, and Asia.
- Previous experience in a small, fast-paced biotech environment is strongly preferred.
- Experience supporting successful regulatory filings (e.g., IND, NDA/BLA).
- Exceptional leadership and interpersonal skills with the ability to influence and build consensus across all levels of the organization.
- Outstanding problem-solving abilities and a strategic mindset, capable of navigating ambiguity and complexity.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex issues to a variety of audiences.
- A proactive, results-oriented leader with a strong sense of urgency and a commitment to excellence.
Benefits & Perks Offered
Our client offers a highly competitive compensation and benefits package designed to attract and retain the best talent in the industry. They believe in investing in their employees’ well-being and professional growth.
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and a significant equity package (stock options) to ensure you share in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents, with a significant portion of the premiums covered by the company.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your financial future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays, to support a healthy work-life balance.
Professional Development
A dedicated budget for professional development, including attendance at key industry conferences, workshops, and continuing education courses.
Wellness Programs
Company-sponsored wellness initiatives and resources to support your physical and mental health.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates who are not local to the San Diego area.
How to Apply
If you are a driven and experienced clinical operations leader with a passion for oncology and a desire to make a significant impact in a growing biotech company, we encourage you to apply. This is a unique opportunity to shape the future of a promising organization and contribute to the development of life-changing therapies for cancer patients.
To be considered for this confidential search, please submit your resume and a cover letter detailing your qualifications and interest in the role. You can learn more about our expertise in this space by visiting the JRG Partners website to connect with our dedicated Life Sciences and Pharmaceutical recruiting team.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
