Role Overview for VP, Clinical Operations with a Rare Disease Firm – Cambridge, MA
JRG Partners is proud to partner with a pioneering, clinical-stage biopharmaceutical company at the forefront of developing novel therapeutics for rare and ultra-rare diseases. Located in the heart of the world’s leading biotechnology hub in Cambridge, MA, our client is driven by a profound mission to deliver life-changing treatments to patients with limited or no therapeutic options. Their innovative science, patient-centric culture, and dynamic team have positioned them as a leader in a challenging and deeply rewarding field. We are seeking a visionary and experienced Vice President (VP) of Clinical Operations to join their executive leadership team and steer the operational execution of their clinical development programs.
This is a transformative opportunity for a strategic leader to build, lead, and scale a world-class clinical operations function. Reporting directly to the Chief Medical Officer, the VP of Clinical Operations will hold ultimate accountability for the strategic planning, execution, and oversight of all clinical trial activities, from first-in-human studies through to regulatory submission and post-marketing commitments. The ideal candidate is a seasoned veteran in the rare disease space, possessing a deep understanding of the unique challenges and opportunities inherent in developing therapies for small patient populations. You will be a hands-on leader, capable of navigating the complexities of global clinical trials while fostering a culture of excellence, urgency, and unwavering commitment to quality and compliance. Your leadership will be instrumental in translating groundbreaking science into tangible therapies that will profoundly impact the lives of patients and their families worldwide.
In this role, you will be the architect of the clinical operations strategy, ensuring that all trials are conducted on time, within budget, and in strict adherence to the highest ethical and regulatory standards. You will leverage your extensive network and experience to select and manage top-tier Contract Research Organizations (CROs) and other vendors, building collaborative partnerships that drive results. As a key member of the leadership team, you will collaborate extensively with cross-functional partners in Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and Program Management to ensure seamless integration and alignment across the organization. If you are a passionate and results-oriented leader eager to make a significant impact in a fast-paced, mission-driven environment, we invite you to apply for this career-defining role.
Key Responsibilities of VP, Clinical Operations with a Rare Disease Firm – Cambridge, MA
The Vice President of Clinical Operations will be responsible for a broad range of strategic and tactical duties, including but not limited to:
Strategic Leadership and Planning
Develop and execute the global clinical operations strategy in alignment with the company’s overall corporate objectives and clinical development plans. Provide strategic input into the design and implementation of clinical protocols, ensuring operational feasibility and patient centricity.
Clinical Trial Oversight and Execution
Assume full accountability for the operational management and execution of all clinical trials (Phase I-IV). This includes meticulous oversight of trial start-up, site selection, patient recruitment and retention strategies, clinical monitoring, data management, and study close-out activities. Ensure all trials are delivered on schedule and within budget.
Team Leadership and Development
Build, lead, mentor, and develop a high-performing, agile clinical operations team. Foster a collaborative and inclusive culture that promotes innovation, accountability, and professional growth. Establish clear performance goals and provide regular feedback and coaching to team members.
Vendor and CRO Management
Lead the identification, evaluation, selection, and management of CROs, central labs, and other clinical trial vendors. Oversee contract negotiations, budget development, and performance management to ensure vendors meet or exceed quality and delivery expectations.
Regulatory Compliance and Quality Assurance
Guarantee that all clinical trial activities are conducted in strict compliance with global regulatory requirements, including FDA regulations, EMA directives, and ICH/Good Clinical Practice (GCP) guidelines. Oversee the development and maintenance of clinical operations Standard Operating Procedures (SOPs) and lead inspection readiness activities.
Financial and Resource Management
Develop, forecast, and manage the clinical operations budget with a high degree of accuracy. Ensure prudent allocation of financial and human resources to achieve program milestones and corporate goals. Proactively identify and mitigate financial risks.
Patient Centricity and Advocacy
Champion a patient-first mindset throughout the clinical development process. Develop and implement strategies to reduce patient burden and enhance the clinical trial experience. Build and maintain strong relationships with patient advocacy groups, such as the National Organization for Rare Disorders (NORD), and key opinion leaders (KOLs) to gather insights that inform trial design and recruitment.
Cross-Functional Collaboration
Serve as the primary clinical operations representative on cross-functional program teams. Work in close partnership with leaders in Clinical Development, Regulatory Affairs, Pharmacovigilance, Biostatistics, and CMC to ensure strategic alignment and seamless execution of the overall development program.
Process Improvement and Innovation
Continuously evaluate and enhance clinical operations processes, systems, and tools to drive efficiency, quality, and scalability. Stay abreast of industry trends and innovative technologies to ensure the company remains at the cutting edge of clinical trial execution.
Requirements for the VP, Clinical Operations with a Rare Disease Firm – Cambridge, MA
The successful candidate will be a proven leader with extensive experience in the biopharmaceutical industry and a passion for rare disease drug development. The required qualifications include:
Educational & Professional Experience:
- An advanced degree (e.g., MS, PhD, PharmD, MD) in a relevant life sciences or healthcare discipline is required.
- A minimum of 15 years of progressive experience in clinical operations within the biotechnology or pharmaceutical industry.
- At least 10 years of experience in a leadership capacity, with demonstrated success in building and managing high-performing clinical operations teams.
Crucially, significant and direct experience in the strategic planning and execution of clinical trials for rare diseases or orphan indications is mandatory.
- Extensive experience managing global clinical trials across all phases of development (Phase I-IV), including direct experience with regulatory submissions (e.g., IND, CTA, NDA, BLA).
- A proven track record of successful vendor and CRO selection, negotiation, and management on a global scale.
Skills and Competencies:
- Expert-level knowledge of FDA and EMA regulations, ICH Guidelines, and Good Clinical Practice (GCP).
- Exceptional leadership and people management skills, with the ability to inspire, motivate, and develop a team in a fast-paced environment.
- Superior strategic thinking, problem-solving, and decision-making capabilities.
- Outstanding interpersonal, verbal, and written communication skills, with the ability to effectively communicate complex information to a variety of audiences.
- Strong financial acumen with experience developing and managing multi-million dollar clinical program budgets.
- Demonstrated ability to work collaboratively and effectively in a cross-functional, matrixed organization.
- High level of personal integrity, a strong sense of urgency, and a commitment to quality and patient safety.
- Ability to adapt to change and thrive in a dynamic, entrepreneurial company culture.
Benefits & Perks Offered
Our client believes in investing in their people and offers a highly competitive and comprehensive benefits package designed to support the well-being and professional growth of their employees. This includes:
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and a significant equity package (stock options) to ensure you share in the company’s long-term success.
Comprehensive Health and Wellness
Top-tier medical, dental, and vision insurance plans for you and your dependents, along with wellness programs and resources.
Retirement Planning
A robust 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays, to support a healthy work-life balance.
Professional Development
Ample opportunities for continued learning and professional growth, including support for attending conferences, workshops, and continuing education.
Inspiring Culture
The opportunity to work alongside a team of brilliant, dedicated, and passionate individuals in a collaborative, mission-driven culture where your contributions have a direct and meaningful impact.
Location
A state-of-the-art facility in Cambridge, MA, offering a vibrant and intellectually stimulating work environment. Relocation assistance may be available for the right candidate.
How to Apply
JRG Partners is exclusively managing the search for this pivotal leadership position. If you are a driven, strategic, and compassionate leader with a proven track record in rare disease clinical operations, we strongly encourage you to apply.
To be considered for this exceptional opportunity, please submit your resume and a detailed cover letter outlining your relevant experience and your passion for advancing therapies for patients with rare diseases. To learn more about our dedicated recruitment expertise in this sector, we invite you to visit our Life Sciences and Healthcare Practice page. We look forward to reviewing your application.
Our client is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
