Role Overview for VP, Clinical Research with a Rare Disease Biotech – Raleigh, NC
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 Research Triangle Park area of Raleigh, NC, our client is driven by a mission to translate groundbreaking science into tangible hope for communities with significant unmet medical needs. We are seeking a visionary and experienced leader to join their executive team as the Vice President of Clinical Research.
This is a pivotal leadership role responsible for providing the strategic direction, execution, and oversight of all clinical research activities. The VP, Clinical Research will be the primary architect of the company’s clinical development strategy, guiding novel therapeutic candidates from early-stage development through to global regulatory submission and market approval. You will lead a dedicated team of clinical professionals and collaborate cross-functionally to ensure that clinical trials are designed and executed with the highest standards of scientific rigor, ethical conduct, and operational excellence. This position offers a unique opportunity to make a profound impact on the lives of patients and to shape the future of a dynamic and rapidly growing organization. The ideal candidate is a strategic thinker, an inspirational leader, and a hands-on expert in the complexities of rare disease drug development.
Key Responsibilities of VP, Clinical Research with a Rare Disease Biotech – Raleigh, NC
The Vice President of Clinical Research will be accountable for the successful execution of the company’s clinical development portfolio. This includes, but is not limited to, the following responsibilities:
Strategic Leadership
Develop and implement the overarching clinical development strategy for the company’s pipeline, ensuring alignment with corporate goals, regulatory pathways, and commercial objectives. Provide scientific and clinical leadership across the organization.
Clinical Program Oversight
Lead the design, planning, execution, and interpretation of all clinical trials (Phase 1-4). This includes protocol development, site selection, patient recruitment strategies, and clinical data analysis and reporting.
Regulatory Strategy and Compliance
Serve as the clinical expert in interactions with global regulatory authorities, including the Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. Ensure all clinical activities are conducted in strict adherence to Good Clinical Practice (GCP), ICH guidelines, and other applicable regulations.
Team Leadership and Development
Build, lead, and mentor a high-performing clinical research team, including professionals in clinical operations, data management, biostatistics, and clinical science. Foster a culture of innovation, collaboration, accountability, and scientific excellence.
Cross-Functional Collaboration
Work in close partnership with leaders in Research & Development, Regulatory Affairs, Medical Affairs, and Commercial teams to ensure seamless integration of clinical development activities within the broader product development lifecycle.
Vendor and CRO Management
Oversee the selection, management, and performance of Contract Research Organizations (CROs), central labs, and other external vendors to ensure timely and high-quality delivery of clinical trial services.
Budget and Resource Management
Develop and manage the clinical research budget, ensuring optimal allocation of financial and human resources to meet program milestones and corporate objectives.
External Engagement
Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs), principal investigators, clinical research sites, and patient advocacy groups to inform clinical trial design and facilitate successful trial execution.
Data Integrity and Interpretation
Oversee the collection, analysis, and interpretation of clinical trial data. Ensure the integrity of the data and lead the preparation of clinical study reports, regulatory submission documents (INDs, NDAs/BLAs), and scientific publications.
Requirements for the VP, Clinical Research with a Rare Disease Biotech – Raleigh, NC
We are seeking a seasoned professional with a proven track record of success in leading clinical research programs within the biopharmaceutical industry. The ideal candidate will possess the following qualifications:
Educational Background
An advanced degree (MD, PhD, or PharmD) is required. An MD with clinical practice experience and board certification in a relevant specialty is highly preferred.
Industry Experience
A minimum of 15 years of progressive experience in clinical research and development within the biotechnology or pharmaceutical industry, with at least 7 years in a senior leadership role.
Therapeutic Area Expertise
Direct, hands-on experience in rare/orphan disease drug development is essential. Experience across multiple therapeutic areas is a plus.
Clinical Development Acumen
Demonstrated success in leading clinical programs through all phases of development, from first-in-human studies to successful regulatory submissions and approvals.
Regulatory Expertise
Deep and current knowledge of the global regulatory landscape, including FDA, EMA, and ICH requirements. Proven experience in leading regulatory interactions and preparing key submission documents.
Leadership Skills
Exceptional leadership, management, and mentoring skills with a demonstrated ability to build and inspire high-performing teams in a fast-paced, dynamic environment.
Strategic and Analytical Thinking
Strong strategic mindset with the ability to integrate scientific, clinical, regulatory, and commercial inputs into a cohesive clinical development plan. Excellent analytical and problem-solving skills are critical.
Communication and Interpersonal Skills
Superior written and verbal communication skills. Must be able to effectively articulate complex scientific and clinical concepts to a wide range of audiences, including internal teams, executive leadership, board members, investors, and external stakeholders.
Location
Ability to work on-site at the company’s headquarters in Raleigh, NC. Relocation assistance is available for the right candidate.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, designed to support the well-being and professional growth of their employees. The comprehensive package includes:
Competitive Compensation
A highly competitive base salary, annual performance-based bonus, and a significant long-term incentive package, including stock options.
Comprehensive Health and Wellness
A full suite of benefits, including medical, dental, and vision insurance for employees and their families, with a significant portion of premiums covered by the company.
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays, to promote a healthy work-life balance.
Professional Development
A strong commitment to employee growth with opportunities for continued learning, including attendance at scientific conferences, workshops, and tuition reimbursement programs.
Relocation Assistance
A comprehensive relocation package is available for qualified candidates moving to the Raleigh, NC area.
Inspiring Work Environment
The opportunity to work alongside a passionate and dedicated team in a collaborative, science-driven culture focused on making a meaningful difference for patients.
How to Apply
If you are a visionary clinical research leader with a passion for rare diseases and a desire to make a transformative impact, we want to hear from you. This is a confidential search managed by JRG Partners.
To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your relevant experience. Qualified candidates can learn more about our recruitment expertise by visiting the JRG Partners’ Life Sciences & Biotechnology practice page. We look forward to reviewing your application and discussing how you can contribute to our client’s success.
