Job Title: Vice President / Director, Clinical Development (Rare Diseases)
Location: Research Triangle Park, Raleigh-Durham, NC (Hybrid)
Employment Type: Full-Time, Permanent
About the Company:
Our client is a fast-growing biopharmaceutical company at the forefront of innovation in rare diseases, with a mission to deliver transformative therapies to patients with high unmet medical needs. The organization has a diverse pipeline spanning early discovery through late-stage clinical programs, with a focus on genetic, metabolic, and neuromuscular disorders that currently lack effective treatment options.
Headquartered in the Research Triangle Park, one of the nation’s leading hubs for life sciences and biotechnology, the company fosters a culture of scientific rigor, collaboration, and patient-centric innovation. With strategic partnerships, strong funding, and a dedicated team of experts, the company is uniquely positioned to make a significant impact in rare disease medicine.
Position Overview:
We are seeking an experienced and visionary Vice President / Director of Clinical Development to lead the design, execution, and oversight of clinical development strategies across the company’s rare disease pipeline. This senior leader will act as the medical and scientific authority on clinical programs, ensuring robust trial design, seamless execution, and regulatory compliance, while keeping patient needs at the center of decision-making.
This is a strategic and hands-on leadership role that requires deep expertise in clinical development, experience with rare disease indications, and the ability to build trusted relationships with regulatory agencies, investigators, patient advocacy groups, and internal stakeholders.
Key Responsibilities:
Strategic Leadership:
- Define and drive the overall clinical development strategy for one or more programs in the rare disease portfolio.
- Provide scientific and medical input into corporate strategy, portfolio prioritization, and business development opportunities.
- Anticipate emerging trends in rare diseases, shaping company strategy to remain at the forefront of innovation.
Clinical Trial Oversight:
- Lead the design, implementation, and execution of early- and late-stage clinical trials, ensuring they meet the highest standards of scientific and operational excellence.
- Oversee medical monitoring, safety reviews, and data interpretation for ongoing studies.
- Ensure development plans are designed with patient feasibility, regulatory expectations, and commercial potential in mind.
Regulatory & External Engagement:
- Serve as the clinical lead for interactions with global regulatory agencies (FDA, EMA, etc.), including preparation and presentation of INDs, NDAs, BLAs, and briefing packages.
- Build and maintain relationships with clinical investigators, academic partners, KOLs, and patient advocacy organizations in the rare disease community.
- Represent the company at scientific conferences and industry forums.
Team Leadership:
- Build, mentor, and manage a team of clinical development physicians and scientists.
- Foster a culture of excellence, accountability, and innovation across the clinical development function.
- Collaborate closely with cross-functional leaders in Clinical Operations, Regulatory Affairs, Translational Medicine, Biometrics, and Commercial Strategy.
Qualifications:
- Medical degree (MD or MD/PhD) required; specialization in Internal Medicine, Genetics, Neurology, Pediatrics, or related therapeutic area strongly preferred.
- 10+ years of clinical development experience in the pharmaceutical/biotechnology industry, with at least 5 years in rare diseases or orphan drug development.
- Demonstrated track record of leading clinical programs through multiple phases of development, including regulatory submission experience.
- Strong understanding of rare disease drug development challenges (e.g., small patient populations, natural history studies, surrogate endpoints).
- Proven ability to interact with regulatory authorities globally and successfully influence development pathways.
- Excellent leadership skills with experience building and guiding high-performing teams.
- Strong communication and presentation abilities, with credibility in both scientific and patient-facing settings.
What’s On Offer:
- A unique opportunity to make a transformative impact on patients and families affected by rare diseases.
- A collaborative, patient-driven culture located in the vibrant Research Triangle Park, one of the top U.S. biotech ecosystems.
- Competitive executive compensation package, including base salary, performance bonus, long-term equity incentives, and comprehensive health and wellness benefits.
- Career-defining opportunity to shape the clinical vision and success of a high-growth biopharmaceutical company.
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
