Role Overview for EVP, Global Drug Development with a Rare Disease Biotech – San Diego, CA
JRG Partners is proud to partner with a pioneering, clinical-stage biotechnology company at the forefront of developing life-changing therapies for patients with rare and ultra-rare diseases. Based in the vibrant biotech ecosystem of San Diego, CA, our client is driven by a mission to translate groundbreaking science into tangible hope for underserved patient communities. They have built a robust pipeline and are poised for significant growth as they advance their lead assets toward regulatory approval and commercialization.
We are seeking a visionary and accomplished Executive Vice President (EVP), Global Drug Development to join their executive leadership team. This is a transformative opportunity for a strategic leader to architect and execute the company’s entire drug development strategy. The EVP will hold ultimate accountability for the integrated development of the company’s portfolio, providing scientific, clinical, and regulatory leadership from preclinical stages through to global marketing authorization and life cycle management.
As a key member of the executive team reporting directly to the Chief Executive Officer (CEO), you will be instrumental in shaping the company’s future. You will be responsible for building and leading a world-class, multi-disciplinary organization encompassing Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, and Program Management. This role demands a leader with deep expertise in rare disease development, a proven track record of regulatory success, and the passion to lead teams in a fast-paced, innovative environment.
The ideal candidate will be a strategic thinker with a hands-on, ‘roll-up-your-sleeves’ mentality, capable of navigating the complexities of orphan drug development while fostering a culture of collaboration, urgency, and scientific rigor. Your leadership will directly impact the company’s ability to deliver on its promise to patients and create significant value for stakeholders.
Key Responsibilities of EVP, Global Drug Development with a Rare Disease Biotech – San Diego, CA
Strategic Vision & Executive Leadership
- Develop, articulate, and execute the integrated global drug development strategy for the company’s entire portfolio, ensuring alignment with corporate goals and commercial objectives.
- Serve as a core member of the executive leadership team, contributing to overall corporate strategy, long-range planning, fundraising activities, and business development evaluations.
- Provide expert guidance to the CEO and Board of Directors on all matters related to clinical and regulatory development, portfolio risk, and opportunities.
- Chair the Development Review Committee and other key governance bodies to ensure programs are advancing according to plan and that strategic decisions are made efficiently.
Clinical Development & Operations
- Provide overarching scientific and clinical leadership for all development programs, from first-in-human studies through pivotal trials and post-marketing commitments.
- Oversee the design of innovative, efficient, and scientifically robust clinical trial protocols that meet global regulatory standards, particularly for rare disease populations.
- Ensure flawless execution of all clinical trials, maintaining the highest standards of quality, ethics, and patient safety in accordance with GCP guidelines.
- Lead the interpretation of clinical trial data and oversee the preparation of clinical study reports, publications, and presentations.
- Manage and provide oversight for Contract Research Organizations (CROs), vendors, and clinical trial sites to ensure delivery on time and within budget.
- Foster strong relationships with Key Opinion Leaders (KOLs), investigators, and patient advocacy groups to inform clinical strategy and trial design.
Global Regulatory Affairs
- Architect and lead the development and implementation of creative and effective global regulatory strategies to achieve expedited approvals and optimal product labeling.
- Serve as the company’s primary senior liaison with global health authorities, including the FDA, EMA, and PMDA, leading key meetings and negotiations.
- Oversee the preparation, submission, and maintenance of all regulatory filings, including INDs, CTAs, BLA/NDAs, MAAs, and Orphan Drug Designations.
- Ensure successful navigation of regulatory pathways for rare diseases, including securing and maintaining designations under regulations like the Orphan Drug Act.
- Stay abreast of the evolving global regulatory landscape and ensure the company’s strategies and processes remain compliant and competitive.
Portfolio & Program Management
- Drive the entire development portfolio forward with a strong sense of urgency and accountability, ensuring programs meet or exceed established timelines, budgets, and quality standards.
- Implement and oversee rigorous program management processes, tools, and dashboards to track progress, identify risks, and facilitate proactive problem-solving.
- Effectively manage program budgets and resources, ensuring optimal allocation to achieve strategic priorities.
Team Leadership & Cross-Functional Collaboration
- Recruit, develop, and retain a world-class, multi-disciplinary drug development organization.
- Provide inspirational leadership, mentorship, and professional development opportunities for your team members.
- Foster a dynamic, collaborative, and patient-centric culture characterized by scientific excellence, transparency, and a commitment to results.
- Work seamlessly with leaders in Research, CMC, Commercial, Finance, and other functions to ensure fully integrated and aligned product development efforts.
Requirements for the EVP, Global Drug Development with a Rare Disease Biotech – San Diego, CA
Educational Background
An advanced degree (MD, PhD, or PharmD) in a relevant scientific discipline is required. An MD is highly preferred for this role due to the deep clinical strategy involved.
Professional Experience
- A minimum of 20 years of progressive, relevant experience in the pharmaceutical or biotechnology industry, with a deep understanding of the entire drug development process.
- At least 10 years in a senior leadership capacity (e.g., Vice President, Senior Vice President) with direct responsibility for multiple functional areas within drug development (e.g., Clinical, Regulatory, Operations).
- Demonstrable, hands-on experience in rare disease drug development is mandatory. Experience with multiple rare disease programs and different therapeutic modalities is highly desirable.
- A proven and verifiable track record of successfully leading multiple drug candidates through the full development lifecycle, resulting in successful global regulatory approvals (BLA/NDA/MAA) and commercial launch.
- Extensive, direct experience interacting and negotiating with the FDA, EMA, and other major global regulatory agencies. Experience leading a company through a successful BLA/NDA filing and approval is essential.
- Experience in a small, fast-growing biotech environment is strongly preferred.
Leadership & Management Skills
- Exceptional leadership capabilities with a proven ability to build, mentor, and inspire high-performing, cross-functional teams in a complex, fast-paced environment.
- A strategic thinker with outstanding business acumen and the ability to translate complex scientific concepts into clear, actionable development plans and corporate strategy.
- Excellent communication, presentation, and interpersonal skills, with the ability to influence and build consensus with diverse stakeholders, including the executive team, board members, investors, and external partners.
- Strong problem-solving and decision-making abilities, with a data-driven approach and the capacity to make sound judgments under pressure.
- High emotional intelligence, integrity, and a deep commitment to patients.
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, including:
Executive Compensation
A highly competitive base salary, a significant annual performance-based bonus, and a substantial equity package (stock options/RSUs) providing meaningful ownership in the company’s success.
Health & Wellness
Premium medical, dental, and vision insurance plans for employees and their eligible dependents with low employee contributions. Access to wellness programs and resources.
Retirement & Financial Security
A 401(k) retirement plan with a strong company matching contribution to help you plan for your future.
Work-Life Balance
An executive-level paid time off (PTO) policy, generous paid company holidays, and company-wide shutdown periods to encourage rest and rejuvenation.
Relocation
A comprehensive relocation package is available for the successful candidate and their family to move to the beautiful and innovative city of San Diego, CA.
Professional Growth
Support for professional development, including attendance at key industry conferences and continuing education.
How to Apply
JRG Partners has been exclusively retained to lead this critical search. We are seeking a passionate and driven leader who is eager to make a profound impact on the lives of patients with rare diseases.
If you are a qualified candidate with the requisite experience and leadership qualities, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter detailing your relevant experience and your interest in the role. All applications will be treated with the strictest confidence.
To learn more about our expertise in recruiting top executive talent for innovative life sciences companies, please visit the JRG Partners’ Life Sciences practice page.
