Role Overview for VP, Clinical Research with a Rare Disease Biotech – San Diego, CA
JRG Partners is proud to partner exclusively with a visionary, patient-focused biotechnology company at the forefront of developing groundbreaking therapies for rare and ultra-rare diseases. Based in the vibrant biotech hub of San Diego, CA, our client is driven by a passion for science and an unwavering commitment to making a tangible difference in the lives of patients with limited or no treatment options. They have cultivated a dynamic, collaborative, and science-driven culture, and are now seeking a strategic and experienced Vice President of Clinical Research to join their executive leadership team.
This is a pivotal, high-impact role responsible for providing the strategic direction, clinical expertise, and operational oversight for the entire clinical development portfolio. The VP, Clinical Research will be the primary architect of the company’s clinical strategy, from early-stage development through to successful regulatory submission and post-marketing activities. You will lead a dedicated team of clinical professionals, fostering a culture of excellence, innovation, and urgency. This position offers a unique opportunity to shape the future of a promising pipeline, directly influence corporate strategy, and bring life-changing therapies from concept to reality. The ideal candidate will be a seasoned physician-scientist with a proven track record of success in rare disease clinical development, possessing both the scientific acumen to guide complex programs and the leadership prowess to inspire a growing organization.
Key Responsibilities of VP, Clinical Research with a Rare Disease Biotech – San Diego, CA
Strategic Leadership & Vision
Develop, articulate, and execute a comprehensive, long-range clinical development strategy for the company’s portfolio of rare disease assets. Provide clinical and scientific leadership across the organization and serve as a key member of the executive team, contributing to overall corporate strategy.
Clinical Program Oversight
Assume ultimate accountability for the design, execution, and interpretation of all clinical trials (Phase 1-4). Ensure that all studies are conducted with the highest standards of scientific integrity, ethical conduct, and operational excellence, in compliance with GCP, ICH, and global regulatory requirements.
Regulatory Strategy & Interaction
Lead the development of clinical sections for regulatory submissions, including INDs, CTAs, NDAs, BLAs, and MAAs. Serve as the primary clinical representative in interactions with global health authorities, such as the FDA, EMA, and others, effectively navigating complex regulatory pathways for orphan drug development.
Team Leadership & Development
Build, lead, mentor, and develop a high-performing clinical research team, including clinical science, clinical operations, and data management/biostatistics functions. Foster a collaborative, accountable, and patient-centric culture within the department.
Cross-Functional Collaboration
Work in close partnership with leaders in Research, Preclinical Development, Regulatory Affairs, Medical Affairs, and Commercial teams to ensure seamless integration and alignment of clinical development plans with broader corporate objectives.
Medical Monitoring & Safety Oversight
Provide expert medical monitoring for ongoing clinical trials. Oversee all pharmacovigilance and drug safety activities, ensuring timely and accurate reporting and assessment of safety data.
Stakeholder Engagement
Cultivate and maintain strong relationships with key opinion leaders (KOLs), principal investigators, patient advocacy groups, and scientific advisors. Effectively represent the company and its clinical programs at scientific conferences and investor meetings.
Budget & Resource Management
Develop and manage the clinical development budget, ensuring optimal allocation of resources. Oversee the selection and management of contract research organizations (CROs), vendors, and clinical trial sites to ensure timely execution of deliverables within budget.
Data Analysis & Publication
Lead the clinical team in the analysis, interpretation, and presentation of clinical trial data. Drive the publication strategy to ensure timely and impactful dissemination of clinical results in peer-reviewed journals and scientific forums.
Requirements for the VP, Clinical Research with a Rare Disease Biotech – San Diego, CA
Educational Background
An MD is required. A PhD or other advanced degree (e.g., PharmD) in a relevant scientific discipline is highly desirable. Board certification in a relevant medical specialty is a plus.
Industry Experience
A minimum of 15 years of progressive experience in clinical research and development within the biotechnology or pharmaceutical industry.
Rare Disease Expertise
A minimum of 5-7 years of direct, hands-on experience in the clinical development of therapies for rare diseases or orphan indications is mandatory. A deep understanding of the unique challenges and opportunities in this space is critical.
Leadership Experience
Proven track record of at least 5 years in a significant leadership role, with experience building and managing high-performing clinical development teams. Experience in a small, fast-paced biotech environment is strongly preferred.
Regulatory Acumen
Extensive experience with global regulatory submissions (IND, NDA/BLA, MAA) and a history of successful interactions with health authorities, particularly the FDA and EMA.
Clinical Trial Expertise
Demonstrated success in designing and executing clinical trials across all phases of development (Phase 1-4). Strong knowledge of trial design, biostatistics, data analysis, and medical monitoring.
Scientific & Strategic Mindset
Strong scientific acumen with the ability to critically evaluate and interpret complex scientific and clinical data. Must be a strategic thinker who can align clinical goals with business objectives.
Communication Skills
Exceptional written and verbal communication skills. Ability to articulate complex scientific concepts clearly and persuasively to a wide range of audiences, including internal teams, external experts, regulatory bodies, and investors.
Personal Attributes
High level of integrity, strong work ethic, and a sense of urgency. A collaborative and influential leader who can thrive in a dynamic, entrepreneurial environment. Must be passionate about patient outcomes and driven by the mission of the company.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, including:
Competitive Salary & Bonus
A highly competitive base salary and an attractive annual performance-based bonus structure.
Significant Equity
A substantial equity package (stock options) to ensure you share in the long-term success of the company.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance for you and your eligible dependents.
Retirement Savings
A 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 strong commitment to your growth with support for attending scientific conferences, workshops, and continuing education.
Relocation Assistance
A comprehensive relocation package is available for the right candidate.
Inspiring Work Environment
The opportunity to work alongside a team of brilliant and passionate individuals in a state-of-the-art facility in San Diego.
How to Apply
JRG Partners is the exclusive recruitment partner for this search. To be considered for this career-defining opportunity, please submit your CV and a cover letter outlining your qualifications and interest in the role. We are committed to a confidential and respectful recruitment process.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
