Role Overview for VP, Clinical Development with a Rare Disease Firm – Cambridge, MA
JRG Partners is proud to represent a pioneering biotechnology firm based in the heart of innovation, Cambridge, MA. Our client is dedicated to developing life-altering therapies for patients suffering from rare and ultra-rare diseases with significant unmet medical needs. Their mission is driven by cutting-edge science, a deep commitment to the patient community, and a culture of collaboration and urgency. They are currently seeking a visionary and experienced leader to join their executive team as the Vice President of Clinical Development.
This is a transformative opportunity for a strategic and hands-on leader to shape the future of the company’s clinical pipeline. The VP of Clinical Development will hold the ultimate responsibility for the strategy, design, execution, and interpretation of all clinical trials. Reporting directly to the Chief Medical Officer, this individual will be a key member of the senior leadership team, providing critical clinical insights that will influence the entire R&D and corporate strategy. The ideal candidate will be a physician-scientist with a profound understanding of the scientific and operational complexities of drug development, particularly within the rare disease landscape.
You will be tasked with building and mentoring a world-class clinical development organization, fostering a culture of scientific rigor, patient-centricity, and executional excellence. Your leadership will be instrumental in translating novel scientific discoveries into approved therapies that bring hope to patients and their families worldwide. This role requires a unique blend of scientific expertise, strategic acumen, regulatory savvy, and inspirational leadership to guide programs from early-stage development through to global regulatory approvals and commercial launch.
Key Responsibilities of VP, Clinical Development with a Rare Disease Firm – Cambridge, MA
Clinical Development Strategy
Architect and implement comprehensive, global clinical development plans for all assets in the portfolio, from first-in-human studies through to post-marketing commitments. Ensure strategies are innovative, efficient, and aligned with corporate goals and the target product profile.
Trial Design and Execution
Provide expert oversight for the design of robust and scientifically sound clinical trial protocols. Lead the clinical team in the flawless execution of all studies, ensuring they are completed on schedule, within budget, and in strict adherence to GCP, ICH guidelines, and all applicable regulatory requirements.
Regulatory Leadership
Serve as the primary clinical representative in interactions with global health authorities, including the FDA, EMA, and others. Lead the preparation and review of critical regulatory documents, including Investigator’s Brochures (IBs), INDs, CTAs, briefing documents, and sections of NDAs/BLAs, adeptly navigating the complexities of orphan drug designation.
Team Leadership and Mentorship
Recruit, develop, and retain a high-performing team of clinical development professionals, including medical directors, clinical scientists, and clinical operations staff. Foster a dynamic, collaborative, and results-oriented culture that empowers team members and promotes professional growth.
Data Analysis and Communication
Oversee the ongoing review, analysis, and interpretation of clinical trial data. Ensure the scientific and clinical integrity of all study results. Drive the development of publications, abstracts, and presentations for scientific congresses and peer-reviewed journals.
Cross-Functional Collaboration
Act as a key partner to leaders across the organization, including Research, Preclinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and Commercial teams. Ensure seamless integration of clinical development activities with the broader drug development process to achieve program milestones.
KOL and Investigator Engagement
Cultivate and maintain strong relationships with key opinion leaders (KOLs), scientific advisors, and principal investigators to ensure our clinical programs are informed by the latest scientific insights and meet the needs of the patient community.
Safety and Pharmacovigilance
Hold ultimate accountability for the safety of all patients enrolled in clinical trials. Oversee the company’s drug safety and pharmacovigilance function, ensuring timely and accurate safety reporting and signal detection.
Budget and Resource Management
Develop and manage the annual clinical development budget, including long-range forecasting. Ensure prudent allocation of financial and human resources to maximize the value of the portfolio and achieve corporate objectives.
Business Development Support
Provide senior clinical expertise for the evaluation of external assets for potential in-licensing or acquisition. Participate in due diligence activities to assess the scientific rationale, clinical feasibility, and potential risks of new opportunities.
Requirements for the VP, Clinical Development with a Rare Disease Firm – Cambridge, MA
Educational Background
An MD or MD/PhD is required. Board certification in a relevant medical specialty (e.g., Neurology, Pediatrics, Genetics, Internal Medicine) is highly preferred.
Industry Experience
A minimum of 15 years of progressive experience in clinical development within the biotechnology or pharmaceutical industry, with a substantial portion of that time focused on rare/orphan diseases.
Leadership Experience
At least 7 years of experience in a leadership role with direct management responsibility for a clinical development team. Proven ability to build, mentor, and lead high-performing teams in a fast-paced environment.
Regulatory Expertise
A demonstrable track record of successful interactions with global regulatory agencies. Direct experience leading the preparation of major regulatory submissions (INDs, NDAs/BLAs) is essential.
Drug Development Acumen
Deep, end-to-end knowledge of the drug development process, from preclinical transition to commercialization. Experience across all phases of clinical development (Phase 1-4) is required.
Scientific Rigor
Strong scientific background with the ability to critically evaluate and interpret preclinical and clinical data, and to translate complex scientific concepts into actionable clinical strategies.
Strategic Thinking
Exceptional strategic thinking and problem-solving skills. Ability to anticipate future trends and challenges in the rare disease space and to develop innovative solutions.
Communication Skills
Outstanding written and verbal communication skills. Ability to effectively articulate complex scientific and clinical concepts to a wide range of audiences, including internal teams, executive leadership, board members, investors, and regulatory authorities.
Personal Attributes
A high level of integrity, a strong sense of urgency, and a patient-first mindset. Must be a collaborative team player who can thrive in a dynamic, entrepreneurial, and science-driven culture.
Benefits & Perks Offered
Our client believes in investing in their employees and offers a highly competitive and comprehensive benefits package designed to support their team’s health, well-being, and financial security. This includes:
Competitive Compensation
A highly competitive base salary, a significant annual performance-based bonus, and a substantial equity package (stock options/RSUs) to ensure you share in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents with low employee contributions.
Retirement Savings
A 401(k) retirement plan with a generous company matching contribution to help you build your financial future.
Generous Time Off
A flexible and generous paid time off (PTO) policy, in addition to company-paid holidays, to support a healthy work-life balance.
Family and Wellness
Comprehensive paid parental leave for new parents, wellness programs, and a fitness center reimbursement to support your overall well-being.
Professional Growth
A strong commitment to employee development with a dedicated budget for attending scientific conferences, continuing education, and other professional development opportunities.
On-Site Perks
A modern and collaborative workspace in Cambridge, commuter benefits, and regular company-sponsored social events to foster a strong sense of community.
Relocation Support
A comprehensive relocation package is available for exceptional candidates who are not local to the Cambridge area.
How to Apply
If you are a passionate and accomplished clinical development leader with a deep commitment to rare diseases, we invite you to apply for this career-defining opportunity. Please submit your resume and a cover letter detailing your relevant experience and your motivation for this role. JRG Partners is committed to a diverse and inclusive workplace. We are an equal opportunity employer and do not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
To learn more about executive opportunities in this sector, we encourage you to explore our Life Sciences practice area for more information. We look forward to reviewing your application.
