JRG Partners is proud to partner with a pioneering, clinical-stage biotechnology company at the forefront of ophthalmology innovation. Based in the vibrant Research Triangle Park area of Raleigh, NC, our client is dedicated to developing transformative therapies to preserve and restore vision for patients suffering from debilitating retinal diseases. With a robust pipeline and strong financial backing, they are entering a pivotal phase of growth and are seeking a visionary and experienced leader to join their executive team as the Vice President of Clinical Affairs.
This is a rare opportunity to shape the future of eye care and make a profound impact on patients’ lives. As the VP of Clinical Affairs, you will be the strategic architect and operational leader of the company’s entire clinical development program. You will provide the vision, leadership, and expertise necessary to advance novel therapeutic candidates from early-stage development through to successful global registration and commercialization. Reporting directly to the Chief Medical Officer, you will be a key voice in corporate strategy, contributing to the long-term success and scientific integrity of the organization. We are looking for a hands-on leader who is passionate about science, driven by a sense of urgency, and committed to building a world-class clinical development organization.
Role Overview for VP, Clinical Affairs with an Ophthalmology Biotech – Raleigh, NC
The Vice President, Clinical Affairs is a cornerstone of the executive leadership team, entrusted with the overarching responsibility for the strategy, direction, and execution of all clinical development activities. This role demands a unique blend of scientific acumen, strategic foresight, and operational excellence. You will be accountable for the entire lifecycle of clinical trials, from initial study design and protocol development to final data analysis, regulatory submission, and publication. Your leadership will be instrumental in navigating the complex regulatory landscape, building strong relationships with key opinion leaders (KOLs), and ensuring that all clinical programs are executed on time, within budget, and to the highest ethical and scientific standards. The ideal candidate will be a seasoned professional with deep domain expertise in ophthalmology and a proven track record of successfully leading clinical programs that have resulted in drug approvals. You will foster a culture of innovation, collaboration, and accountability within your team and across the organization, ensuring that the patient remains at the center of all development efforts. This position offers a significant opportunity to influence the trajectory of a dynamic biotech company and to lead the charge in bringing sight-saving treatments to market.
Key Responsibilities of VP, Clinical Affairs with an Ophthalmology Biotech – Raleigh, NC
Strategic Leadership
Develop and execute the comprehensive, long-range Clinical Development Plan (CDP) for all pipeline assets in alignment with corporate objectives. Provide strategic clinical input for portfolio management, business development activities, and long-term corporate planning.
Clinical Trial Execution
Assume overall responsibility for the design, implementation, management, and oversight of all clinical trials (Phase I-IV). This includes protocol development, site selection, patient recruitment strategies, study monitoring, and data collection.
Regulatory Strategy & Compliance
Lead the preparation and review of clinical sections for all regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA)/Biologics License Applications (BLA), and other global regulatory filings. Ensure all clinical activities are conducted in strict adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and other applicable global standards.
Team Development & Management
Build, lead, mentor, and manage a high-performing clinical affairs team, encompassing Clinical Operations, Biostatistics, and Clinical Data Management. Foster a collaborative, results-oriented, and patient-focused culture.
Vendor & CRO Management
Lead the selection, negotiation, and management of Contract Research Organizations (CROs), central labs, and other clinical trial vendors. Establish performance metrics and ensure vendors deliver high-quality results on schedule and within budget.
Fiscal Oversight
Develop and manage the clinical affairs budget, providing accurate forecasting, resource allocation, and financial oversight for all clinical programs. Ensure efficient use of resources to achieve company goals.
External Engagement
Serve as the primary clinical representative of the company to external stakeholders, including regulatory agencies (FDA, EMA), investigators, clinical site staff, and ethics committees/IRBs. Cultivate and maintain strong relationships with global KOLs and scientific advisors in the ophthalmology community.
Data Analysis & Interpretation
Oversee the analysis and interpretation of clinical trial data in collaboration with Biostatistics and other R&D functions. Ensure the timely and accurate reporting of clinical trial results.
Scientific Communication
Drive the clinical contribution to scientific abstracts, posters, presentations, and peer-reviewed publications to ensure the dissemination of clinical trial findings to the scientific and medical communities.
Cross-Functional Collaboration
Work seamlessly with other key functions, including Research, Preclinical Development, Regulatory Affairs, Medical Affairs, and Commercial, to ensure a fully integrated and aligned product development strategy.
Requirements for the VP, Clinical Affairs with an Ophthalmology Biotech – Raleigh, NC
Required Qualifications:
- An advanced degree (MD, PhD, or PharmD) is required. An MD with a specialization in Ophthalmology is strongly preferred.
- A minimum of 15 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 10 years in a clinical development leadership role.
- Significant and direct experience in the therapeutic area of Ophthalmology is mandatory. A proven track record of managing clinical trials for retinal diseases (e.g., AMD, diabetic retinopathy, glaucoma) is highly desirable.
- Demonstrated experience leading a clinical program through the full development lifecycle, from IND filing to successful NDA/BLA approval.
- Extensive experience in managing and overseeing global clinical trials, including direct interaction with major regulatory authorities such as the FDA and EMA.
- Proven ability to build, lead, and develop a high-functioning clinical affairs organization.
- In-depth knowledge of GCP, ICH guidelines, and other global regulatory requirements.
- Exceptional strategic thinking, problem-solving, and analytical skills.
- Outstanding written and verbal communication skills, with the ability to effectively present complex scientific concepts to diverse audiences.
Preferred Qualifications:
- Experience in a small, fast-paced biotech environment.
- Experience with novel therapeutic modalities, such as gene therapy or biologics, in ophthalmology.
- An established network of relationships with KOLs and clinical investigators in the ophthalmology field.
- Experience managing both early and late-stage clinical development programs.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
- Highly competitive base salary and annual performance-based bonus.
- Significant long-term incentive plan, including meaningful equity/stock options.
- Comprehensive health, dental, and vision insurance for you and your dependents.
- Robust 401(k) plan with a generous company match.
- Generous paid time off (PTO), including vacation, sick leave, and paid company holidays.
- A full relocation assistance package for qualified candidates.
- Support for professional development, including attendance at key industry conferences.
- The opportunity to work in a dynamic, innovative, and collaborative culture with a passionate team dedicated to a common mission.
How to Apply
If you are a strategic and results-driven clinical development leader with a passion for ophthalmology and a desire to make a tangible impact on patients’ lives, we want to hear from you. This is a critical leadership role that will shape the future of a promising biotech company.
To be considered for this exclusive opportunity, please submit your resume and a cover letter detailing your relevant experience. JRG Partners is the exclusive recruitment partner for this search. For more information or to see how this role fits within our portfolio of executive searches, we invite you to explore other opportunities in our Life Sciences practice. We look forward to reviewing your application.
