Head of Clinical Trial Strategy – San Diego, CA

Role Overview for Head of Clinical Trial Strategy – San Diego, CA

JRG Partners is proud to partner with a pioneering, clinical-stage biotechnology company at the forefront of developing transformative therapies for patients with unmet medical needs. Located in the vibrant biotech hub of San Diego, CA, our client is driven by a passion for scientific innovation and a commitment to improving human health. We are seeking a visionary and highly experienced Head of Clinical Trial Strategy to join their executive leadership team. This is a paramount role responsible for providing the strategic direction, scientific leadership, and operational oversight for the entire clinical development portfolio.

The successful candidate will be the chief architect of the company’s clinical trial programs, from early-stage proof-of-concept studies to pivotal late-stage global trials. You will be instrumental in shaping the future of the organization by ensuring that clinical strategies are scientifically rigorous, operationally feasible, and aligned with both regulatory expectations and commercial objectives. This position demands a unique blend of deep scientific expertise, strategic foresight, regulatory acumen, and inspirational leadership. You will lead a dedicated team of clinical professionals and collaborate extensively with cross-functional leaders across Research & Development, Regulatory Affairs, Medical Affairs, and Commercial departments. If you are a strategic thinker with a proven track record of bringing novel therapies through the clinical development lifecycle and are eager to make a tangible impact on patients’ lives, this is an unparalleled opportunity to lead and innovate within a dynamic and supportive environment.

Key Responsibilities of Head of Clinical Trial Strategy – San Diego, CA

The Head of Clinical Trial Strategy will be accountable for the following key functions, driving the clinical pipeline towards successful regulatory approval and market launch:

Clinical Development Leadership

Provide overarching strategic leadership for all clinical development programs. Author and champion the integrated Clinical Development Plans (CDPs) for all pipeline assets, defining the path from first-in-human studies to registration and lifecycle management.

Innovative Trial Design and Protocol Development

Oversee the design and development of innovative, efficient, and robust clinical trial protocols. Champion the integration of novel methodologies, adaptive designs, and biomarker strategies to optimize trial outcomes, accelerate timelines, and increase the probability of success.

Portfolio and Program Management

Assume executive responsibility for the entire clinical trial portfolio. Ensure strategic alignment of all clinical activities with corporate goals, manage program budgets and resources effectively, and oversee timelines to ensure key milestones are met.

Regulatory Strategy and Interaction

In partnership with Regulatory Affairs, develop and execute a global regulatory strategy. Serve as a key scientific representative in interactions with health authorities, including the FDA, EMA, and others. Lead the clinical contribution to major regulatory submissions, such as INDs, CTAs, NDAs, and BLAs.

Cross-Functional Collaboration and Influence

Foster a highly collaborative environment, working seamlessly with leaders in Preclinical, Biostatistics, Data Management, Medical Affairs, and Commercial teams. Ensure that clinical strategy is informed by and informs the broader drug development and commercialization process.

CRO and Vendor Oversight

Lead the selection, management, and oversight of Contract Research Organizations (CROs), central labs, and other external vendors. Ensure that partners are delivering high-quality results on time and within budget, and that they operate as a true extension of the internal team.

Data Analysis and Interpretation

Guide the clinical team in the ongoing review, analysis, and interpretation of clinical trial data. Be accountable for the integrity and quality of the data and its presentation in clinical study reports, publications, and regulatory filings.

Team Building and Mentorship

Recruit, lead, and develop a world-class clinical strategy and operations team. Mentor team members to foster their professional growth and cultivate a culture of scientific excellence, urgency, and accountability.

Risk Identification and Mitigation

Proactively identify potential scientific, operational, and regulatory risks within the clinical programs. Develop and implement robust mitigation strategies to safeguard program timelines and outcomes.

Scientific and Medical Community Engagement

Represent the company and its clinical programs at scientific conferences, advisory boards, and investigator meetings. Build and maintain strong relationships with key opinion leaders (KOLs) and principal investigators to ensure clinical programs are well-designed and highly regarded.

Requirements for the Head of Clinical Trial Strategy – San Diego, CA

We are seeking an exceptional leader with a deep understanding of the intricacies of clinical drug development. The ideal candidate will possess the following qualifications and attributes:

Educational Background

An advanced degree in a relevant scientific field is required. MD, PhD, or PharmD is strongly preferred.

Extensive Industry Experience

A minimum of 15+ years of progressive experience in the pharmaceutical or biotechnology industry, with at least 10 years in a leadership role with direct responsibility for clinical trial strategy and execution.

Proven Leadership

Demonstrated track record of building and leading high-performing clinical development teams. Experience managing direct reports and influencing in a matrixed organization is essential.

Deep Therapeutic Area Knowledge

Significant experience in a specific therapeutic area such as oncology, immunology, neurology, or rare diseases is highly desirable. The ability to quickly learn new therapeutic areas is critical.

Regulatory Expertise

Expert-level knowledge of the entire drug development process and a comprehensive understanding of global regulatory requirements and guidelines (e.g., GCP, ICH). Must have a proven history of successful interactions with health authorities and direct involvement in successful major regulatory filings (IND, NDA/BLA).

Strategic and Analytical Thinking

Superior strategic thinking, problem-solving, and analytical skills. Ability to synthesize complex information to make critical decisions and articulate a clear, compelling vision for the clinical development path.

Exceptional Communication Skills

Flawless written, verbal, and presentation skills. The ability to effectively communicate complex scientific and clinical concepts to a wide range of audiences, from internal executive teams and boards of directors to external investigators and regulatory bodies.

Business and Financial Acumen

Strong business acumen with experience in budget development, resource planning, and financial oversight of large-scale clinical programs.

Location

Must be able to work on-site at the company’s headquarters in San Diego, CA. A comprehensive relocation package is available for the ideal candidate.

Benefits & Perks Offered

Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. As a key member of the leadership team, you can expect:

Competitive Compensation

A highly competitive base salary, a significant annual performance-based bonus, and a substantial equity package (stock options/RSUs) to ensure you share in the company’s long-term success.

Comprehensive Health and Wellness

Premier medical, dental, and vision insurance for you and your dependents. The package includes robust wellness programs, mental health support, and a fitness reimbursement plan.

Retirement Savings

A 401(k) retirement plan with a generous company matching contribution to help you plan for your future.

Generous Paid Time Off

A flexible and generous paid time off (PTO) policy, in addition to company-wide paid holidays and shutdown periods, to promote a healthy work-life balance.

Professional Growth

A dedicated budget for professional development, including attendance at major scientific conferences, leadership training programs, and continuing education courses.

Relocation Support

A comprehensive, executive-level relocation package is available to support a smooth transition to the beautiful San Diego area.

How to Apply

JRG Partners is exclusively managing the search for this pivotal Head of Clinical Trial Strategy role. If you are a qualified and passionate leader ready to shape the future of clinical development, we encourage you to apply. Please submit your resume and a cover letter detailing your relevant experience. For more information on our expertise in this sector, please visit our Clinical Research Recruiters practice area page. Our client is an Equal Opportunity Employer and values diversity in its workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.