Role Overview for VP, Clinical Affairs with an Oncology Biotech – San Diego, CA
JRG Partners is proud to partner with a pioneering, clinical-stage biotechnology company at the forefront of oncological innovation. Located in the vibrant biotech hub of San Diego, CA, our client is dedicated to developing and commercializing a new generation of targeted therapies to transform the lives of cancer patients. Their robust pipeline is built on a deep understanding of cancer biology, and they are poised for significant growth as they advance their lead assets through pivotal clinical trials.
We are seeking a visionary and experienced Vice President (VP) of Clinical Affairs to join their executive leadership team. This is a rare opportunity to shape the clinical strategy and execution for a company with the potential to redefine cancer treatment paradigms. The VP, Clinical Affairs will be the primary architect of the clinical development plans, providing strategic direction, medical oversight, and operational leadership for all clinical programs. This individual will be instrumental in guiding the company’s novel therapies through the complexities of global clinical development, from first-in-human studies to regulatory submission and market approval.
Reporting directly to the Chief Medical Officer, this role offers a unique blend of high-level strategy and hands-on leadership. The ideal candidate will be a seasoned physician-scientist or clinical development expert with a proven track record in oncology. You will be responsible for building and mentoring a world-class clinical affairs organization, fostering a culture of scientific excellence, urgency, and patient-centricity. This is more than a job; it is a chance to leave an indelible mark on the fight against cancer and contribute to a legacy of medical breakthroughs.
Key Responsibilities of VP, Clinical Affairs with an Oncology Biotech – San Diego, CA
The Vice President of Clinical Affairs will be the driving force behind our client’s clinical development engine. This role requires a blend of scientific rigor, strategic vision, and operational excellence. The successful candidate will be accountable for the following:
Strategic Clinical Leadership
Develop, articulate, and execute the overarching clinical development strategy for the entire oncology portfolio. This includes authoring and overseeing the creation of comprehensive Clinical Development Plans (CDPs), defining target patient populations, establishing endpoints, and outlining the path to regulatory approval in key global markets. You will serve as a key member of the executive team, providing critical clinical insights to inform corporate strategy, portfolio management, and business development activities.
End-to-End Clinical Program Oversight
Assume full responsibility for the design, implementation, and execution of all clinical trials (Phase I-IV). This includes protocol development, site selection, investigator engagement, and patient recruitment strategies. You will ensure that all studies are conducted on time, within budget, and in strict adherence to the highest ethical and quality standards, including compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulations.
Regulatory Strategy and Interaction
Act as the primary clinical point of contact for global health authorities, including the FDA, EMA, and others. You will lead the clinical team in preparing and presenting comprehensive clinical data packages for regulatory submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). Your expertise will be crucial in navigating the regulatory landscape and securing timely approvals.
Team Leadership and Development
Build, mentor, and lead a high-performing, multi-disciplinary Clinical Affairs team, encompassing Clinical Operations, Clinical Science, Medical Writing, Data Management, and Biostatistics. You will foster a collaborative, innovative, and accountable culture, empowering team members and promoting their professional growth. This includes resource planning, performance management, and organizational development to scale the team with the company’s growth.
Data Interpretation and Scientific Communication
Provide expert medical and scientific oversight for all clinical programs. This involves leading the analysis and interpretation of clinical trial data, ensuring its accuracy and clinical relevance. You will be responsible for communicating study results through high-impact publications in peer-reviewed journals, presentations at major medical conferences, and inclusion in regulatory documents.
Cross-Functional Partnership
Champion collaboration across the organization. You will work seamlessly with colleagues in Research & Development, Regulatory Affairs, CMC, Commercial, and Medical Affairs to ensure full alignment and integration of the clinical strategy with the overall drug development and commercialization plan. Your ability to build consensus and drive projects forward in a matrixed environment is critical.
KOL and Investigator Relations
Cultivate and maintain strong, collaborative relationships with Key Opinion Leaders (KOLs), principal investigators, clinical research coordinators, and advisory boards. You will leverage these relationships to gather expert insights, inform clinical trial design, and ensure the successful execution of studies.
Fiscal and Resource Management
Develop, manage, and oversee the annual Clinical Affairs budget, ensuring the efficient allocation of financial and human resources to meet program milestones. You will be responsible for the selection and management of Contract Research Organizations (CROs) and other external vendors, holding them accountable for performance and delivery.
Requirements for the VP, Clinical Affairs with an Oncology Biotech – San Diego, CA
This is a senior executive role that demands a specific and extensive set of qualifications. We are seeking a candidate who not only meets but exceeds the following criteria:
Educational Background
An advanced degree (MD, PhD, or PharmD) is required. For MD candidates, board certification in Oncology or Hematology/Oncology is strongly preferred. A deep and intuitive understanding of the science behind cancer therapeutics is essential.
Industry Experience
A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 10 years dedicated to hands-on clinical development. The candidate must have a demonstrable track record of successfully leading oncology programs from early-stage development (Phase I) through to late-stage trials (Phase III) and regulatory approval.
Oncology Expertise
Extensive experience in oncology drug development is non-negotiable. Experience with targeted therapies, immuno-oncology, or cell therapies is highly desirable. The ideal candidate will have a history of designing and executing innovative and efficient clinical trials in solid tumors or hematologic malignancies.
Leadership and Management
A minimum of 7 years of experience in a significant leadership capacity, with proven success in building, managing, and inspiring high-performing clinical teams. Must possess exceptional leadership qualities, including the ability to influence, motivate, and mentor individuals at all levels.
Regulatory Prowess
A sophisticated understanding of the global regulatory environment, with direct, hands-on experience interacting with the FDA and EMA. Proven experience in leading the development of clinical sections for major regulatory submissions (INDs, NDAs/BLAs) is mandatory.
Core Competencies
Superior strategic thinking and problem-solving skills. Excellent written and verbal communication skills, with the ability to clearly articulate complex scientific and clinical concepts to a variety of audiences. Must be adaptable, resilient, and able to thrive in a fast-paced, dynamic, and resource-constrained biotech environment. A strong sense of integrity, ethics, and a patient-first mindset are paramount.
Benefits & Perks Offered
Our client believes in rewarding its leaders for their contributions to a life-changing mission. They offer a highly competitive and comprehensive benefits package designed to support the well-being and financial security of their employees and their families. This includes:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance bonus and a substantial equity package (stock options/RSUs) to ensure you share in the company’s long-term success.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for you and your dependents. The package also includes life insurance, short-term and long-term disability coverage, and access to an Employee Assistance Program (EAP).
Retirement and Financial Planning
A robust 401(k) retirement plan with a generous company matching contribution to help you plan for your future.
Work-Life Balance
A generous Paid Time Off (PTO) policy, including vacation, sick leave, and company-paid holidays, to encourage a healthy work-life integration.
Career Growth and Development
Ample opportunities for professional growth, including support for attending major scientific and medical conferences, continuing education, and leadership development programs.
Relocation Support
A comprehensive relocation package is available for exceptional candidates who are not currently based in the San Diego area.
How to Apply
JRG Partners is exclusively managing this search on behalf of our client. If you are a visionary clinical leader with a passion for oncology and the experience to drive transformative therapies from concept to approval, we invite you to apply.
To be considered for this pivotal role, please submit your resume and a cover letter detailing your relevant experience and strategic vision for clinical development. For more information about our expertise in this sector and other executive opportunities, please visit our Biotechnology & Pharmaceutical practice area page.
We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
