Role Overview for VP, Clinical Development with a Diagnostics Firm – Irvine, CA
JRG Partners is exclusively representing a pioneering, fast-growing diagnostics firm in their search for a visionary Vice President of Clinical Development. Based in the vibrant biotech hub of Irvine, California, this executive leadership role is a unique opportunity to shape the future of diagnostic medicine. Our client is at the forefront of developing innovative diagnostic solutions that have a direct impact on patient outcomes and global health. As the VP of Clinical Development, you will be the strategic architect and operational leader of the entire clinical function. You will provide the scientific and medical leadership necessary to advance a diverse pipeline of diagnostic products from early-stage development through to global regulatory approval and commercialization. This is a highly visible role that requires a blend of scientific rigor, strategic acumen, and inspirational leadership. You will be responsible for building and mentoring a world-class clinical team, establishing best-in-class processes, and driving a culture of excellence and urgency. Reporting directly to the Chief Medical Officer, you will be a key member of the executive leadership team, contributing significantly to the company’s overall strategy and long-term success. If you are a seasoned clinical development leader with a passion for innovation and a proven track record in the diagnostics space, we invite you to consider this exceptional opportunity to make a lasting impact.
Key Responsibilities of VP, Clinical Development with a Diagnostics Firm – Irvine, CA
The Vice President of Clinical Development will assume a broad range of responsibilities, encompassing strategic oversight and hands-on execution. Your primary goal is to ensure the successful design, implementation, and completion of all clinical programs.
Strategic Leadership and Vision
Develop, articulate, and execute the comprehensive, long-range clinical development strategy for the company’s entire diagnostics portfolio. Ensure that all clinical plans are rigorously designed, scientifically sound, and fully aligned with corporate goals, regulatory requirements, and commercial objectives.
Clinical Trial Oversight
Provide senior-level oversight for the entire lifecycle of clinical trials, from protocol design and feasibility assessment to study execution, data analysis, and final reporting. Ensure all studies are conducted in strict adherence to Good Clinical Practice (GCP), ICH guidelines, and other applicable global regulations.
Regulatory Strategy and Interaction
Serve as the primary clinical representative in interactions with global regulatory bodies, including the FDA, EMA, and other health authorities. Lead the development and authoring of key clinical sections for regulatory submissions, such as Investigational Device Exemptions (IDEs), Pre-Market Approvals (PMAs), and 510(k)s.
Team Building and Mentorship
Recruit, lead, and develop a high-performing clinical development team, including clinical operations, clinical science, biostatistics, and data management professionals. Foster a collaborative, innovative, and results-oriented culture that attracts and retains top talent.
Cross-Functional Collaboration
Act as a key collaborative partner to other functional leaders across the organization, including Research & Development, Medical Affairs, Quality Assurance, Commercial, and Business Development. Ensure seamless communication and integration of clinical activities with the broader product development lifecycle.
Data Integrity and Interpretation
Uphold the highest standards of data quality and scientific integrity. Oversee the robust statistical analysis of clinical trial data and lead the team in the critical interpretation of results, translating complex data into actionable insights for strategic decision-making.
Budget and Resource Management
Develop, manage, and maintain accountability for the entire clinical development budget. Ensure efficient allocation of financial and human resources to maximize productivity and achieve program milestones on time and within scope.
External Stakeholder Management
Cultivate and manage strong relationships with Key Opinion Leaders (KOLs), clinical investigators, academic partners, Contract Research Organizations (CROs), and other vendors. Represent the company at scientific conferences, advisory boards, and investigator meetings.
Scientific Communication
Oversee the development of clinical trial publications, including manuscripts for peer-reviewed journals, abstracts, and presentations for major medical and scientific congresses, ensuring the timely dissemination of key clinical data.
Risk Management
Proactively identify potential risks and challenges within clinical programs. Develop and implement effective mitigation strategies to ensure program success and protect patient safety.
Requirements for the VP, Clinical Development with a Diagnostics Firm – Irvine, CA
The ideal candidate will be a results-driven leader with deep expertise in clinical development and a passion for bringing innovative diagnostics to market. We are seeking an individual with the following qualifications:
Educational Background
An advanced degree (MD, PhD, or PharmD) in a relevant life sciences discipline is required. An MD is highly preferred.
Industry Experience
A minimum of 15 years of progressive experience within the biotechnology, pharmaceutical, or medical device/diagnostics industry, with at least 10 of those years dedicated specifically to clinical development.
Leadership Experience
A minimum of 7 years in a senior leadership role with demonstrable experience building, managing, and mentoring successful clinical development teams. Proven ability to lead and influence in a matrixed environment.
Diagnostics Expertise
A strong track record in the clinical development of in vitro diagnostics (IVD) is essential. Experience with companion diagnostics (CDx), molecular diagnostics, or immunoassay development is highly advantageous.
Regulatory Acumen
Deep and comprehensive knowledge of the global regulatory landscape for diagnostics. Extensive, hands-on experience with FDA regulatory submissions (IDE, 510(k), PMA) and interactions with regulatory agencies is mandatory.
Clinical Trial Mastery
Proven success in designing and executing complex, multi-center, global clinical trials that have led to successful product approvals.
Strategic and Analytical Mindset
Exceptional strategic thinking, critical analysis, and problem-solving skills. The ability to navigate ambiguity and make sound decisions based on a synthesis of complex scientific, clinical, and business information.
Communication Skills
Superior written, verbal, and presentation skills. The ability to effectively communicate complex scientific concepts to a wide range of audiences, from internal teams and executive leadership to external KOLs and regulatory authorities.
Business Acumen
A solid understanding of the commercial aspects of product development and the ability to contribute to broader business strategy.
Location and Travel
Must be able to work from the corporate headquarters in Irvine, CA. The role may require up to 25% domestic and international travel.
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 and significant annual executive bonus potential.
- A substantial long-term incentive package, including stock options or equity grants.
- Comprehensive medical, 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), including vacation, sick days, and company holidays.
- Support for professional development, including attendance at conferences and continuing education.
- A comprehensive relocation assistance package for qualified candidates.
- The opportunity to work in a dynamic, innovative, and mission-driven culture with a team of passionate professionals.
How to Apply
JRG Partners is proud to be the exclusive recruitment partner for this confidential search. We are seeking a visionary leader ready to take on the challenge of driving clinical innovation in the diagnostics field. If you possess the required experience and leadership qualities to excel in this pivotal role, we strongly encourage you to apply.
A dedicated JRG Partners recruiter will review your qualifications and contact you if your background is a strong match for this executive opportunity. We look forward to connecting with you and exploring this exciting career path together.
