Role Overview for Director, Clinical Development with a Gene Therapy Co. – San Francisco, CA
JRG Partners is proud to represent a pioneering, clinical-stage gene therapy company based in the vibrant biotechnology hub of San Francisco, CA. Our client is on a mission to develop transformative, one-time curative therapies for patients with severe and life-threatening genetic disorders. With a robust pipeline, cutting-edge science, and a culture of innovation, they are poised to make a significant impact on modern medicine. We are seeking a visionary and experienced Director of Clinical Development to join their dynamic team and provide strategic leadership for their lead clinical programs.
This is a pivotal leadership role that will shape the future of the company’s clinical portfolio. The Director will be the central figure responsible for the overarching clinical development strategy, from late-stage preclinical transition through to regulatory submission and approval. You will be at the forefront of designing and executing innovative, patient-centric clinical trials that are both scientifically rigorous and operationally efficient. This position offers a unique opportunity to blend deep scientific expertise with strategic clinical insight in one of the most exciting and rapidly advancing fields of medicine.
As the Director, you will serve as the clinical lead on cross-functional program teams, collaborating closely with colleagues in Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Commercial. Your medical and scientific leadership will be critical in interpreting complex clinical data, navigating the evolving regulatory landscape for gene therapies, and communicating the value of these novel treatments to internal and external stakeholders, including Key Opinion Leaders (KOLs), investigators, and regulatory authorities. The ideal candidate is a strategic thinker, a passionate leader, and a dedicated physician-scientist committed to bringing hope and healing to patients in desperate need.
Key Responsibilities of Director, Clinical Development with a Gene Therapy Co. – San Francisco, CA
The Director of Clinical Development will hold comprehensive responsibility for the clinical and medical aspects of their assigned gene therapy programs. This includes strategic planning, trial execution, data analysis, and team leadership to ensure program milestones are achieved with the highest standards of quality and compliance.
Clinical Strategy and Protocol Design
Lead the creation and evolution of the Clinical Development Plan (CDP) for assigned programs. Design, author, and review innovative and scientifically sound clinical trial protocols, amendments, and related documents for Phase 1-3 studies.
Trial Execution and Medical Monitoring
Provide senior-level medical oversight and monitoring for ongoing clinical trials. Serve as the primary medical point of contact for clinical sites, investigators, and CROs, ensuring patient safety and data integrity are paramount.
Data Analysis and Interpretation
Drive the analysis and interpretation of clinical trial data in collaboration with biostatistics and data management. Critically evaluate emerging data to inform program decisions, risk mitigation strategies, and future trial designs.
Regulatory Leadership
Author and review clinical sections of key regulatory documents, including Investigator’s Brochures (IBs), Investigational New Drug (IND) applications, Biologics License Applications (BLAs), and responses to health authority inquiries. Represent the clinical team in key meetings with the FDA, EMA, and other global regulatory bodies.
Cross-Functional Team Leadership
Serve as the clinical science lead on the global program team. Provide strategic clinical input and guidance to all functional areas, ensuring alignment on program goals, timelines, and budgets.
Stakeholder Engagement and Communication
Develop and maintain strong relationships with global KOLs, scientific advisors, and patient advocacy groups. Prepare and present clinical data at major scientific conferences, advisory board meetings, and investor relations events.
Safety and Pharmacovigilance
In partnership with the Drug Safety team, oversee all aspects of safety monitoring, including the review of safety reports, signal detection, and the development of risk management plans.
Mentorship and Management
Lead, mentor, and develop a team of clinical scientists, providing scientific guidance and fostering a culture of excellence, collaboration, and continuous learning.
Requirements for the Director, Clinical Development with a Gene Therapy Co. – San Francisco, CA
We are seeking a highly qualified and motivated individual with a proven track record of success in clinical development, particularly within complex and innovative therapeutic areas. The successful candidate will possess a strong blend of scientific knowledge, clinical expertise, and leadership capabilities.
Educational Background
An MD, MD/PhD, or equivalent advanced medical degree is required. Board certification in a relevant medical specialty (e.g., Neurology, Hematology, Oncology, or Medical Genetics) is strongly preferred.
Industry Experience
A minimum of 8 years of progressive experience in clinical development within the biotechnology or pharmaceutical industry. Direct experience in gene therapy, cell therapy, or rare/orphan diseases is essential for this role.
Clinical Trial Expertise
Demonstrated experience in leading clinical trials across all phases of development (Phase 1-3). Proven success in designing and executing complex clinical studies and a deep understanding of the operational challenges involved.
Regulatory Acumen
Substantial experience with regulatory interactions and submissions (e.g., IND, BLA/MAA). A thorough understanding of the unique challenges and global regulatory requirements for gene therapy products is critical.
Leadership and Influence
Exceptional leadership skills with a demonstrated ability to lead and inspire cross-functional teams in a matrixed organization. Experience managing and mentoring junior clinical staff is highly desirable.
Scientific and Analytical Skills
Strong scientific acumen with the ability to critically evaluate, interpret, and present complex scientific and clinical data. Solid understanding of biostatistics, pharmacokinetics, and clinical pharmacology.
Communication and Interpersonal Skills
Impeccable written and verbal communication skills. Must be a confident and articulate presenter, capable of effectively engaging with a wide range of audiences from C-suite executives to clinical site coordinators.
Mindset
A proactive, results-oriented individual with high ethical standards, a strong sense of urgency, and the ability to thrive in a fast-paced, innovative, and collaborative environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a comprehensive and competitive compensation and benefits package. They believe in investing in their employees’ well-being, professional growth, and financial security.
Competitive Compensation
A highly attractive base salary complemented by a significant annual performance-based bonus and a substantial equity package (stock options) to ensure you share in the company’s long-term success.
Comprehensive Health and Wellness
Premier medical, dental, and vision insurance plans for you and your eligible dependents. The package includes access to a Health Savings Account (HSA), a generous wellness stipend, and robust mental health support programs.
Retirement Savings
A 401(k) retirement plan featuring a generous company match to help you build a secure financial future.
Work-Life Balance
A flexible and generous Paid Time Off (PTO) policy, in addition to paid company holidays and sick leave, to support a healthy work-life integration.
Career Development
A strong commitment to professional growth with support for attending key scientific conferences, pursuing continuing education, and accessing internal career advancement opportunities.
Exceptional Work Environment
A dynamic, science-driven, and collaborative culture located in a modern, state-of-the-art facility. Enjoy perks such as commuter benefits, catered lunches, and engaging team-building activities that foster a strong sense of community.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. If you are a visionary clinical development leader passionate about advancing the field of gene therapy, we encourage you to apply. To be considered for this career-defining opportunity, please submit your resume and a cover letter detailing your relevant experience.
For more information on this role or to explore other opportunities within our portfolio, please visit our Life Sciences and Biotechnology practice area. We look forward to connecting with you and discussing how you can contribute to this groundbreaking work. All applications will be treated with the strictest confidence. Our client is an equal opportunity employer dedicated to building a diverse and inclusive team.
