Role Overview for Chief Development Officer with a Cell & Gene Therapy Firm – San Diego, CA
JRG Partners is proud to announce an exclusive executive search for a Chief Development Officer (CDO) on behalf of our client, a pioneering, clinical-stage cell and gene therapy company based in the vibrant biotech hub of San Diego, CA. This is a rare opportunity to join a dynamic and well-funded organization at a pivotal moment in its growth. The CDO will be a cornerstone of the executive leadership team, reporting directly to the Chief Executive Officer, and will be entrusted with the monumental task of shaping and executing the company’s entire clinical development and regulatory strategy.
The successful candidate will be a visionary leader with a profound understanding of the complexities of bringing novel cell and gene therapies from the laboratory to the patient’s bedside. You will assume ultimate responsibility for the entire development pipeline, overseeing programs from late-stage preclinical development through all phases of clinical trials, regulatory submissions, and ultimately, commercial approval. This role demands a unique blend of scientific rigor, strategic acumen, operational excellence, and inspirational leadership. You will be responsible for building, mentoring, and leading a world-class, multi-disciplinary team encompassing clinical development, clinical operations, regulatory affairs, medical affairs, and pharmacovigilance. Your leadership will be instrumental in translating groundbreaking science into life-changing medicines for patients with critical unmet needs. This position requires a hands-on, yet highly strategic, executive who can thrive in a fast-paced, innovative, and collaborative environment. Your contributions will directly impact the company’s trajectory and its ability to deliver on the promise of cellular and genetic medicine.
Key Responsibilities of Chief Development Officer with a Cell & Gene Therapy Firm – San Diego, CA
Strategic Clinical Leadership
Develop, articulate, and execute a comprehensive, integrated clinical development strategy for the company’s portfolio of cell and gene therapy candidates. This includes defining clinical endpoints, target product profiles, and go-to-market strategies in alignment with corporate objectives.
Pipeline Execution and Oversight
Provide senior oversight for the entire development lifecycle. This includes managing the design, execution, and interpretation of all clinical trials (Phase I-IV), ensuring they are conducted on time, within budget, and in full compliance with GCP, regulatory standards, and ethical guidelines.
Regulatory Strategy and Interaction
Lead the development and implementation of global regulatory strategies. Serve as the primary point of contact with health authorities, including the FDA, EMA, and other international agencies. You will be responsible for leading the preparation and submission of all regulatory documents, such as INDs, CTAs, BLAs, and MAAs.
Team Building and Mentorship
Recruit, lead, and develop a high-performing, integrated development organization. Foster a culture of scientific excellence, innovation, collaboration, and urgency. Provide mentorship and guidance to senior leaders within clinical development, clinical operations, medical affairs, and regulatory affairs.
Cross-Functional Collaboration
Serve as a key member of the executive team, working seamlessly with leaders in Research, CMC (Chemistry, Manufacturing, and Controls), Commercial, and Business Development to ensure full alignment and integration of the development plan with broader corporate goals.
Medical and Scientific Oversight
Provide expert medical and scientific oversight for all clinical programs. Ensure the highest standards of patient safety are maintained across all trials through robust pharmacovigilance and risk management planning.
External Engagement
Represent the company and its clinical programs to external stakeholders, including key opinion leaders (KOLs), scientific advisory boards, investors, and potential partners. Present data at major scientific and medical conferences.
Budget and Resource Management
Develop and manage the annual budget for the entire development organization. Ensure efficient allocation of financial and human resources to meet strategic priorities and program milestones.
Data-Driven Decision Making
Champion the use of data and analytics to inform clinical strategy, trial design, and go/no-go decisions. Stay abreast of the latest scientific advancements, competitive landscape, and regulatory trends in the cell and gene therapy field.
Requirements for the Chief Development Officer with a Cell & Gene Therapy Firm – San Diego, CA
Educational Background
An MD, PhD, or MD/PhD is required. Board certification in a relevant specialty such as Oncology, Hematology, or Immunology is highly preferred.
Executive Experience
A minimum of 15 years of progressive experience within the biopharmaceutical industry, with at least 10 years in a senior leadership role overseeing clinical development functions.
Domain Expertise
Deep and direct experience in the clinical development of cell and/or gene therapies (e.g., CAR-T, TCR, TIL, AAV, lentiviral vectors) is mandatory. Specific experience in oncology, rare diseases, or immunology is strongly desired.
Proven Regulatory Track Record
Demonstrable success in leading development programs through major regulatory milestones. This includes extensive experience with IND/CTA filings and a proven track record of successfully filing at least one BLA/MAA that led to marketing approval. The ideal candidate will be an expert in navigating complex FDA regulatory guidelines for advanced therapies.
Leadership and Management Skills
Exceptional leadership capabilities with a proven ability to build and manage high-performing, multi-disciplinary teams. Must possess outstanding strategic thinking, problem-solving, and decision-making skills.
Communication Skills
Superior communication, presentation, and interpersonal skills. The ability to effectively articulate complex scientific and clinical concepts to a wide range of audiences, from internal teams to external investors and regulatory bodies.
Business Acumen
Strong understanding of the entire drug development process, from discovery to commercialization. Experience working in a small, agile biotech environment and contributing to corporate strategy, fundraising, and business development activities is a significant plus.
Location
Must be willing to be based in the San Diego, CA area, with the ability to travel domestically and internationally as required.
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:
- A highly competitive base salary commensurate with executive-level experience.
- Significant annual performance-based bonus potential.
- A substantial equity package (stock options and/or RSUs) providing a meaningful opportunity for ownership and long-term wealth creation.
- Comprehensive health, dental, and vision insurance for you and your dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), sick leave, and paid company holidays.
- A comprehensive relocation assistance package for qualified candidates.
- Support for professional development, including attendance at key industry conferences and continued education.
- Access to executive wellness programs and other perks designed to support a healthy work-life balance.
How to Apply
JRG Partners is the exclusive search firm retained for this critical Chief Development Officer position. We invite all qualified and interested candidates to submit their curriculum vitae and a cover letter detailing their relevant experience and interest in the role. All applications will be treated with the strictest confidentiality.
To apply, please submit your application through our secure portal. We look forward to reviewing your qualifications and discussing how you can make a transformative impact on the future of medicine with our client.
