Role Overview for VP, Clinical Trial Innovation with a Rare Disease Biotech – San Diego, CA
At our client, a pioneering biotechnology company headquartered in the vibrant life sciences hub of San Diego, CA, we are driven by a singular, urgent mission: to develop life-altering therapies for patients battling rare and ultra-rare diseases. Our science is cutting-edge, our team is world-class, and our commitment to patients is absolute. We are seeking a transformative leader to join our executive team as the Vice President of Clinical Trial Innovation. This is not merely a leadership position; it is a career-defining opportunity to architect the future of clinical development within one of the most challenging and rewarding fields in medicine.
The successful candidate will be the central force driving the strategy, design, and implementation of novel, patient-centric, and technologically advanced clinical trial methodologies. You will challenge conventional paradigms, champion new approaches, and ultimately accelerate the delivery of groundbreaking treatments to patient communities with immense unmet needs. As a key member of the Clinical Development leadership team, you will report directly to the Chief Medical Officer and will be responsible for building and leading a dedicated function focused on making clinical trials smarter, faster, and more accessible for rare disease patients globally.
This role is ideal for a forward-thinking visionary who thrives in a dynamic, scientifically rigorous, and highly collaborative environment. You will have the autonomy to build and shape a world-class innovation function, leveraging cutting-edge tools and a deep commitment from the entire organization to redefine what is possible in rare disease research. If you are passionate about harnessing technology and novel approaches to solve complex clinical challenges, this is your opportunity to make an indelible impact on the lives of patients and their families.
Key Responsibilities of VP, Clinical Trial Innovation with a Rare Disease Biotech – San Diego, CA
Strategic Vision and Leadership
Develop, articulate, and execute a comprehensive, long-term global strategy for clinical trial innovation that aligns with the company’s overall R&D and corporate objectives. Serve as the primary thought leader and internal expert on emerging trends, technologies, and methodologies in clinical research, influencing decision-making at the highest levels of the organization.
Innovative Trial Design and Execution
Champion and oversee the integration of novel clinical trial designs, including but not limited to, adaptive trials, master protocols, platform trials, basket trials, and seamless Phase 2/3 designs. Ensure these designs are scientifically sound, operationally feasible, and tailored to the unique challenges of rare disease populations, such as small sample sizes and heterogeneous disease expression.
Digital Health and Technology Integration
Lead the identification, evaluation, and implementation of cutting-edge digital health technologies to optimize clinical trials. This includes wearables, remote monitoring sensors, eCOA/ePRO, telemedicine platforms, and other tools that enhance data collection, improve patient experience, and provide novel endpoints.
Decentralized Clinical Trial (DCT) Strategy
Architect and operationalize a robust strategy for the implementation of decentralized clinical trials (DCTs) and hybrid models. This involves developing new workflows, managing technology vendors, ensuring data integrity, and navigating the evolving regulatory landscape to bring trials closer to patients’ homes, reducing the burden of participation.
Patient-Centricity and Engagement
Embed the patient voice into every stage of the clinical trial lifecycle. Develop and implement strategies for meaningful patient engagement, including collaboration with patient advocacy groups, utilization of patient-reported outcomes, and designing trials that minimize patient and caregiver burden.
Data Science and Real-World Evidence (RWE) Integration
Partner closely with the Biostatistics and Data Science teams to leverage advanced analytics, artificial intelligence (AI), and machine learning (ML) for protocol optimization, patient identification, predictive modeling, and site selection. Drive the strategy for incorporating Real-World Data (RWD) and Real-World Evidence (RWE) to supplement traditional trial data and support regulatory submissions.
Cross-Functional Partnership
Foster a culture of innovation and collaboration across the organization. Work seamlessly with leaders in Clinical Operations, Regulatory Affairs, Medical Affairs, Biomarker Sciences, Commercial, and IT to ensure cohesive and successful execution of innovative initiatives.
Team Development and Mentorship
Recruit, lead, and mentor a high-performing team of clinical innovation specialists. Cultivate a culture of curiosity, continuous learning, and excellence, empowering your team to push boundaries and achieve ambitious goals.
Regulatory Strategy and Engagement
Proactively engage with global health authorities (FDA, EMA, etc.) to discuss innovative trial designs and novel endpoints. Stay at the forefront of evolving regulatory guidance and contribute to shaping future policies through industry consortia and publications.
Operational Excellence and Performance Metrics
Establish key performance indicators (KPIs) to measure the impact of innovation initiatives on trial speed, cost, quality, and patient engagement. Drive a continuous improvement mindset to refine processes and scale successful approaches across the portfolio.
Vendor and Partnership Management
Identify and manage strategic partnerships with technology vendors, academic institutions, and contract research organizations (CROs) to access external expertise and cutting-edge solutions. Oversee vendor selection, contracting, and performance management to ensure maximum value and successful implementation.
Requirements for the VP, Clinical Trial Innovation with a Rare Disease Biotech – San Diego, CA
Educational Background
An advanced degree (MD, PhD, or PharmD) is strongly preferred. A Master’s degree in a relevant scientific discipline combined with exceptional industry experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 8-10 years in a senior leadership capacity overseeing clinical development, clinical operations, or a related function.
Rare Disease Expertise
Demonstrated, in-depth experience in the design and execution of clinical trials for rare or ultra-rare diseases is mandatory. A profound understanding of the unique scientific, operational, and regulatory challenges associated with small patient populations is critical for success.
Innovation Track Record
A proven and verifiable track record of successfully championing, designing, and implementing innovative clinical trial methodologies and technologies (e.g., DCTs, adaptive designs, digital endpoints) that have had a tangible impact on development programs.
Regulatory Acumen
Deep and current knowledge of global regulatory requirements and guidelines (GCP, ICH) and extensive experience interacting with major health authorities on complex and novel clinical development plans.
Leadership and Influence
Exceptional leadership skills with a demonstrated ability to build and lead high-performing teams from the ground up. Must possess outstanding influencing, negotiation, and communication skills, with the ability to articulate complex concepts to diverse audiences, from the Board of Directors to project teams.
Strategic and Analytical Mindset
Superior strategic thinking and problem-solving abilities. Capable of analyzing complex situations, identifying key drivers, and translating strategy into actionable plans with measurable outcomes.
Technical Proficiency
Strong familiarity with the landscape of clinical trial technologies, data analytics platforms, and digital health solutions. Must be comfortable and credible when discussing technical solutions with internal and external experts.
Cultural Fit
A collaborative, roll-up-your-sleeves mentality well-suited for a fast-paced, entrepreneurial biotech environment. A deep passion for science and an unwavering commitment to patients are essential.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a comprehensive and rewarding benefits package. They believe in investing in their employees’ health, well-being, and financial future.
Highly Competitive Compensation
A comprehensive and compelling compensation package, including a competitive base salary, an aggressive annual performance bonus, and a significant long-term equity grant (stock options/RSUs) to ensure you share in the company’s success.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance for you and your dependents, with low employee contributions. Access to wellness programs, mental health support, and a generous health savings account (HSA) with company funding.
Retirement Planning
A robust 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A belief in the importance of rest and rejuvenation, reflected in a generous paid time off (PTO) policy, paid company holidays, and flexible work arrangements.
Professional Growth
A strong commitment to your professional development, with an annual budget for conferences, workshops, certifications, and other learning opportunities to keep you at the forefront of the industry.
Relocation Support
A comprehensive relocation package is available for exceptional candidates to facilitate a smooth transition to the beautiful San Diego area.
Inspiring Work Environment
A state-of-the-art office and lab space designed for collaboration and innovation, located in the heart of one of the world’s leading biotech ecosystems.
How to Apply
This is a retained search exclusively managed by JRG Partners. If you are a transformative clinical development leader with the vision and experience to redefine rare disease research, we invite you to take the next step in your career. To be considered for this confidential opportunity, please submit your curriculum vitae and a cover letter outlining your specific achievements in clinical trial innovation. For a confidential discussion and to learn more, please connect with JRG Partners.
