Role Overview for VP, Clinical Development with a Gene Therapy Firm – San Diego, CA
JRG Partners is proud to partner with a visionary, clinical-stage gene therapy company based in the vibrant biotechnology hub of San Diego, CA. Our client is at the forefront of medical innovation, dedicated to developing potentially curative, one-time treatments for patients with severe and life-threatening genetic diseases. With a robust pipeline and a culture of scientific excellence, they are poised to make a profound impact on human health. We are seeking a transformative leader to join their executive team as the Vice President, Clinical Development.
This is a career-defining opportunity for a seasoned physician-scientist to provide strategic leadership and clinical oversight for the entire development portfolio. The VP, Clinical Development will be the primary architect of the company’s clinical strategy, responsible for designing and executing innovative, efficient, and patient-centric clinical trials. You will serve as the lead clinical voice both internally and externally, guiding programs from early-stage development through to successful regulatory submission and commercialization.
This role requires a unique blend of scientific rigor, strategic thinking, and inspirational leadership to navigate the complex and rapidly evolving field of gene therapy. You will be instrumental in shaping the company’s future, building a world-class clinical team, and, most importantly, bringing hope and transformative therapies to patients and families in desperate need. Your work will involve navigating the complex regulatory landscape for novel treatments, as outlined by agencies such as the U.S. Food and Drug Administration (FDA), to ensure that groundbreaking science translates into approved, accessible medicines.
Key Responsibilities of VP, Clinical Development with a Gene Therapy Firm – San Diego, CA
Strategic Clinical Leadership
You will develop, articulate, and execute the overarching clinical development strategy for the company’s entire gene therapy pipeline. This includes defining and authoring comprehensive Clinical Development Plans (CDPs), Target Product Profiles (TPPs), and integrated program timelines and budgets. You will be responsible for conducting rigorous assessments of the competitive landscape to ensure our client’s programs are differentiated and positioned for success. Your strategic vision will directly influence portfolio prioritization and long-term corporate goals.
Clinical Program Design and Execution
Provide expert medical and scientific leadership for the design, execution, and interpretation of all clinical trials (Phase 1-3). You will have ultimate accountability for the quality and integrity of study protocols, investigator brochures, and clinical study reports. This includes overseeing site selection and initiation, managing relationships with Contract Research Organizations (CROs) and other vendors, and ensuring all clinical activities are conducted in strict adherence to Good Clinical Practice (GCP) guidelines and global regulatory standards.
Regulatory Strategy and Interaction
Serve as the primary clinical point of contact with global regulatory authorities, including the FDA, EMA, and others. You will lead the clinical strategy for and preparation of key regulatory submissions, such as Investigational New Drug (IND) applications, briefing documents, and Biologics License Applications (BLAs). You will represent the company and lead the clinical team in pivotal regulatory meetings, skillfully articulating the clinical and scientific rationale for the development programs.
Team Development and Mentorship
Build, lead, and mentor a high-performing team of clinical development professionals, including medical directors, clinical scientists, and clinical operations staff. You will foster a culture of scientific curiosity, collaboration, urgency, and accountability. Your leadership will be crucial in attracting top talent and providing the guidance and development opportunities necessary to ensure the team’s growth and success.
Cross-Functional Partnership and Influence
Act as a key member of the senior leadership team, fostering a highly collaborative environment. You will work in close partnership with leaders in Research/Discovery to translate novel science into viable clinical candidates, with CMC to ensure clinical supply, with Regulatory Affairs to align on global strategy, and with Commercial and Medical Affairs to prepare for successful product launches. Your ability to influence and align stakeholders across the organization will be critical to program success.
Data Analysis, Interpretation, and Communication
Oversee the analysis and interpretation of clinical trial data in partnership with biostatistics and data management. You will be responsible for ensuring the scientific and clinical integrity of all data interpretations and communications. You will present compelling and accurate data to internal executive teams, boards of directors, scientific advisory boards, investors, and at major medical and scientific conferences.
Medical and Safety Oversight
Uphold the highest standards of patient safety across all clinical programs. You will provide medical oversight for all trials, lead the clinical safety review process, and work closely with the pharmacovigilance team to monitor, evaluate, and report all safety data. You will be the ultimate decision-maker on clinical safety and risk-management strategies for the portfolio.
Requirements for the VP, Clinical Development with a Gene Therapy Firm – San Diego, CA
Educational Background
An M.D. is required. An M.D./Ph.D. is highly preferred. Board certification in a relevant medical specialty (e.g., Neurology, Hematology, Oncology, Medical Genetics) is a significant asset.
Extensive Industry Experience
A minimum of 15 years of experience in the biotechnology or pharmaceutical industry, with at least 10 years in a direct clinical development role. Must have a proven track record of successfully leading programs through all phases of development.
Senior Leadership Experience
At least 5-7 years of experience in a senior leadership role, with direct responsibility for managing and mentoring clinical development teams and managing significant budgets.
Gene/Cell Therapy Expertise
Direct, hands-on experience in the clinical development of gene therapies, cell therapies, or other advanced therapy medicinal products (ATMPs) is essential. Experience with rare diseases is strongly preferred.
Regulatory Acumen
Demonstrated expertise in the global regulatory landscape for advanced therapies. Must have a proven track record of successful IND submissions and significant involvement in at least one BLA/MAA submission and approval.
Strategic and Analytical Skills
Superior strategic thinking capabilities with the ability to integrate clinical, scientific, and commercial objectives. Must possess strong analytical skills and the ability to make data-driven decisions in a complex and fast-paced environment.
Exceptional Communication Skills
Outstanding written, verbal, and presentation skills. Must have the ability to articulate complex scientific and clinical concepts clearly and persuasively to a wide range of audiences, from scientific experts to investors and board members.
Leadership and Influence
Proven ability to lead, influence, and motivate cross-functional teams. Must exhibit strong executive presence, emotional intelligence, and a collaborative spirit. A proactive, “roll-up-your-sleeves” mentality is critical for success in this dynamic environment.
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:
- An executive-level base salary and annual performance-based bonus program.
- A substantial equity grant (stock options/RSUs) with significant upside potential.
- Comprehensive, premium health, dental, and vision insurance plans for you and your eligible dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), including vacation, sick leave, and paid company holidays.
- A comprehensive executive relocation package for qualified candidates.
- Support for professional development, including attendance at key industry conferences and leadership training.
- A dynamic, inclusive, and mission-driven company culture where your contributions have a direct impact on patients’ lives.
How to Apply
This is a retained search exclusively managed by JRG Partners. If you are a visionary clinical development leader with a passion for gene therapy and a desire to build a company that will change the face of medicine, we invite you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter. JRG Partners is a leader in executive recruitment for the life sciences sector. To learn more about our expertise and other opportunities, please visit our Life Sciences Executive Search practice area page. We look forward to connecting with you.
