Role Overview for VP, Clinical Research Strategy 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. We are seeking a visionary and experienced leader to join their executive team as the Vice President of Clinical Research Strategy. This is a paramount role for an individual passionate about transforming the landscape of cancer treatment.
Our client is at the forefront of developing next-generation therapeutics, targeting novel pathways to address significant unmet needs in oncology. The successful candidate will be the principal architect of the company’s clinical development vision, responsible for designing and executing a comprehensive strategy that will guide novel assets from early-phase development through to regulatory approval and commercialization.
As the VP of Clinical Research Strategy, you will provide the scientific, medical, and strategic leadership necessary to build a world-class clinical development organization. You will be instrumental in shaping the company’s portfolio, evaluating new therapeutic opportunities, and ensuring that all clinical programs are designed with scientific rigor, patient centricity, and regulatory success in mind.
This position requires a unique blend of deep scientific knowledge in oncology, extensive experience in clinical trial design and execution, and a proven ability to lead and inspire cross-functional teams in a dynamic, fast-paced environment. You will serve as a key member of the senior leadership team, reporting directly to the Chief Medical Officer, and your contributions will have a direct and profound impact on the company’s trajectory and, most importantly, on the lives of patients battling cancer.
Key Responsibilities of VP, Clinical Research Strategy with an Oncology Biotech – San Diego, CA
The VP of Clinical Research Strategy will have a broad range of responsibilities, encompassing strategic oversight, operational execution, and team leadership. Your duties will be critical to the advancement of our client’s innovative oncology pipeline.
Strategic Clinical Leadership
- Develop, articulate, and execute the overarching, long-term clinical development strategy for the entire oncology portfolio, ensuring alignment with corporate goals and commercial objectives.
- Provide expert medical and scientific leadership for all clinical programs, from first-in-human studies through to pivotal registration trials and post-marketing activities.
- Continuously evaluate the competitive landscape, emerging scientific data, and evolving treatment paradigms to ensure the company’s clinical strategy remains innovative and competitive.
- Chair the clinical development team and serve as a key decision-maker on program progression, go/no-go decisions, and resource allocation.
- Collaborate with the executive team on portfolio management, in-licensing opportunities, and external partnership strategies.
Clinical Development and Trial Design
- Lead the design of innovative, efficient, and scientifically robust clinical trial protocols that are optimized for success, incorporating novel endpoints and translational science objectives.
- Author and review key clinical and regulatory documents, including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and sections of regulatory submissions (INDs, NDAs, BLAs).
- Oversee the development of Target Product Profiles (TPPs) and comprehensive Clinical Development Plans (CDPs) for all pipeline assets.
- Ensure that patient safety is the highest priority, overseeing the activities of the drug safety and pharmacovigilance functions for all ongoing trials.
- Provide medical monitoring oversight for clinical studies, either directly or through management of a team of medical monitors.
Regulatory and Compliance Oversight
- Serve as the primary clinical representative in interactions with global regulatory authorities, including the FDA, EMA, and other health agencies.
- Lead the clinical strategy for regulatory submissions, providing expert input and guidance throughout the process to achieve successful outcomes.
- Ensure all clinical development activities are conducted with the highest level of ethical and scientific integrity, in strict adherence to international standards and Good Clinical Practice (GCP) guidelines.
- Stay abreast of changes in the global regulatory landscape and guide the company in adapting its strategies accordingly.
Team Leadership and Development
- Build, lead, and mentor a high-performing clinical research team, including medical directors, clinical scientists, and clinical operations professionals.
- Foster a culture of scientific excellence, innovation, collaboration, and urgency within the clinical development organization.
- Provide ongoing coaching, performance management, and career development opportunities for team members.
- Effectively manage departmental budgets, resources, and timelines to ensure the achievement of clinical milestones.
External Engagement and Collaboration
- Establish and maintain strong relationships with key opinion leaders (KOLs), principal investigators, academic partners, and clinical research organizations (CROs).
- Represent the company at scientific conferences, advisory boards, and investor meetings, effectively communicating the clinical strategy and data.
- Oversee the publication and presentation strategy for clinical trial data in peer-reviewed journals and at major medical congresses.
- Collaborate seamlessly with cross-functional partners in Research, Translational Medicine, Biostatistics, Regulatory Affairs, and Commercial to ensure integrated and successful drug development.
Requirements for the VP, Clinical Research Strategy with an Oncology Biotech – San Diego, CA
We are seeking a candidate with a distinguished track record of success in oncology clinical development. The ideal individual will possess the following qualifications and attributes:
Educational Background
An advanced degree (MD, PhD, or PharmD) is required. An MD with board certification in Oncology or Hematology/Oncology is strongly preferred.
Professional Experience
A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 10 years dedicated to oncology clinical research and development.
Leadership Experience
A minimum of 7 years of experience in a leadership role, with a proven track record of successfully building and managing high-performing clinical development teams.
Oncology Expertise
Deep and broad expertise across various tumor types and therapeutic modalities (e.g., small molecules, biologics, cell therapy, immuno-oncology). Early-phase and late-phase development experience is essential.
Regulatory Acumen
Extensive experience with global regulatory authorities and a proven track record of successful regulatory submissions (e.g., INDs, NDAs/BLAs). Direct involvement in at least one major oncology drug approval is highly desirable.
Strategic Mindset
Demonstrated ability to think strategically, analyze complex issues, and make sound decisions in a fast-paced environment. Must be able to translate scientific insights into actionable clinical strategies.
Communication Skills
Exceptional written and verbal communication skills. The ability to articulate complex scientific concepts to a wide range of audiences, from internal teams to external stakeholders, is critical.
Collaborative Spirit
A strong team player with excellent interpersonal skills and the ability to influence and align stakeholders across the organization.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Competitive Compensation
A highly competitive base salary, annual performance-based bonus, and a significant long-term incentive package (stock options/equity).
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents.
Retirement Savings
A robust 401(k) plan with a generous company match.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and company holidays.
Professional Development
A dedicated budget for continuous learning, including attendance at scientific conferences, workshops, and courses.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates moving to the San Diego area.
Wellness Programs
Company-sponsored wellness initiatives and resources to support employee health and well-being.
How to Apply
This is a retained search conducted exclusively by JRG Partners. If you are a visionary clinical development leader with a passion for oncology and a desire to make a transformative impact on patient care, we encourage you to apply.
To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role. Qualified candidates are encouraged to explore our expertise and apply through the JRG Partners portal. For more information on our specialized recruitment services in this sector, please visit our Life Sciences and Biotechnology Practice Area page. We look forward to reviewing your application.
