Role Overview for Head of Clinical Development with an Ophthalmology Biotech – Raleigh, NC
JRG Partners is proud to represent a pioneering, venture-backed ophthalmology biotechnology company in their search for a transformative Head of Clinical Development. Located in the heart of the vibrant Research Triangle Park (RTP) in Raleigh, NC, our client is at the forefront of developing groundbreaking therapies to combat debilitating retinal and ocular diseases. This is a rare opportunity to join a dynamic executive leadership team and shape the future of a company poised to revolutionize patient care in ophthalmology.
As the Head of Clinical Development, you will be the strategic architect and hands-on leader of the company’s entire clinical pipeline. This pivotal role carries the ultimate responsibility for driving all clinical programs from early-stage development (Phase I) through to successful regulatory submission and market approval (Phase III/IV). You will provide the scientific, medical, and operational leadership necessary to build a world-class clinical development organization. This position demands a unique blend of scientific rigor, strategic foresight, regulatory savvy, and inspirational leadership.
The ideal candidate is a seasoned physician-scientist or a highly experienced clinical development professional with a deep and demonstrable track record in ophthalmology. You are not just a manager; you are a builder, a strategist, and a visionary who can translate complex science into executable clinical plans that meet the highest ethical and regulatory standards. You will serve as the primary clinical voice of the company, interacting with the Board of Directors, investors, regulatory agencies, and the global ophthalmology community. This is a career-defining role for a passionate individual dedicated to bringing sight-saving innovations to patients worldwide.
Key Responsibilities of Head of Clinical Development with an Ophthalmology Biotech – Raleigh, NC
The Head of Clinical Development will have a broad range of responsibilities, encompassing strategic leadership, clinical trial execution, regulatory affairs, and team management. Your success will be measured by your ability to advance the company’s assets through the clinical lifecycle efficiently and effectively.
Clinical Development Strategy
Develop, articulate, and execute a comprehensive, integrated clinical development strategy for all assets in the pipeline. This includes defining target product profiles, establishing clinical endpoints, and creating innovative trial designs that are both scientifically robust and operationally feasible.
Leadership and Team Management
Build, lead, and mentor a high-performing clinical development team, including clinical operations, clinical science, and data management professionals. Foster a culture of scientific excellence, urgency, collaboration, and accountability.
Clinical Trial Oversight
Provide senior oversight for the design, execution, and interpretation of all clinical trials. Ensure studies are conducted in strict adherence to Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulations. You will be responsible for trial timelines, budgets, and overall quality.
Regulatory Strategy and Interaction
In partnership with the regulatory affairs team, you will lead the development of the global regulatory strategy. You will be the lead clinical representative in key interactions with health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), guiding the preparation of INDs, NDAs, BLAs, and other critical regulatory submissions.
Data Analysis and Communication
Oversee the analysis and interpretation of clinical trial data, ensuring its accuracy and integrity. You will be responsible for communicating study results through publications, presentations at scientific conferences, and internal/external stakeholder meetings.
KOL and Investigator Relations
Cultivate and maintain strong, collaborative relationships with Key Opinion Leaders (KOLs), clinical investigators, and scientific advisors in the ophthalmology community. Leverage these relationships to inform clinical strategy and ensure successful trial recruitment and execution.
Cross-Functional Collaboration
Serve as a key member of the executive team, working closely with leaders in Research, Preclinical Development, CMC, Commercial, and Business Development to ensure seamless integration and alignment of the clinical strategy with overall corporate objectives.
Budget and Resource Management
Develop and manage the annual clinical development budget, ensuring optimal allocation of resources. You will be accountable for financial forecasting and oversight of all clinical program expenditures, including CRO and vendor management.
Safety and Pharmacovigilance
Provide medical oversight for all clinical programs, ensuring patient safety is paramount. You will oversee the company’s pharmacovigilance and drug safety functions, including the review and reporting of adverse events.
Requirements for the Head of Clinical Development with an Ophthalmology Biotech – Raleigh, NC
We are seeking an exceptional candidate with a proven history of success in leading ophthalmology clinical development programs within the biopharmaceutical industry. The following qualifications are essential for this role:
Educational Background
An MD, PhD, or PharmD is required. An MD with a board certification or significant clinical experience in Ophthalmology is strongly preferred.
Industry Experience
A minimum of 15 years of progressive experience within the biotechnology or pharmaceutical industry, with at least 10 years in a direct clinical development role.
Therapeutic Area Expertise
Deep expertise in ophthalmology is a non-negotiable requirement. Candidates must have direct experience designing and running clinical trials for retinal diseases, glaucoma, or other serious ocular conditions.
Proven Leadership
Demonstrated experience building and leading clinical development teams. A track record of hiring, mentoring, and developing top talent is essential. You must possess the executive presence to effectively communicate with a Board of Directors and external stakeholders.
Regulatory Success
A proven track record of leading clinical programs through the entire development lifecycle, culminating in successful NDA/BLA/MAA submissions and approvals. Direct, hands-on experience in meetings and negotiations with the FDA and other global health authorities is required.
Strategic and Analytical Skills
Exceptional strategic thinking capabilities with the ability to analyze complex issues and make sound, data-driven decisions. You must be able to translate scientific insights into actionable clinical strategies.
Communication Skills
Outstanding written and verbal communication skills. The ability to clearly articulate complex scientific and clinical concepts to a wide range of audiences, from scientists and clinicians to investors and commercial partners.
Adaptability
Must be able to thrive in a fast-paced, entrepreneurial environment. A hands-on, roll-up-your-sleeves mentality is critical for success in this lean and agile organization.
Benefits & Perks Offered
Our client believes in rewarding their employees for their commitment and contributions. They offer a highly competitive compensation and benefits package designed to attract and retain the best talent in the industry, including:
Executive Compensation
A highly competitive base salary and an aggressive annual performance-based bonus structure.
Meaningful Equity
A significant stock option grant, providing the opportunity to share directly in the company’s long-term success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents.
Retirement Savings
A 401(k) retirement plan with a generous company matching contribution.
Generous Time Off
A flexible and generous paid time off (PTO) policy, in addition to company-paid holidays, to support work-life balance.
Relocation Support
A comprehensive relocation package is available for the successful candidate and their family.
Professional Growth
Ample opportunities for professional development, including support for attending major scientific and medical conferences.
Innovative Culture
The chance to work alongside a team of brilliant, dedicated, and passionate colleagues in a collaborative, science-driven culture.
How to Apply
JRG Partners is the exclusive recruitment partner for this confidential search. We are seeking a visionary leader who is passionate about ophthalmology and driven to bring life-changing therapies to patients. If your experience and aspirations align with this unique opportunity, we invite you to begin a confidential conversation with us.
To apply, please submit your curriculum vitae and a detailed cover letter outlining your suitability for the role. For more information about our specialized recruitment services in this field, we invite you to visit our Life Sciences & Biotechnology Practice page. We look forward to reviewing your application.
