Role Overview for VP, Clinical Trial Management with a Rare Disease Biotech – Cambridge, MA
JRG Partners is proud to represent a pioneering, patient-centric biotechnology company at the forefront of developing life-altering therapies for rare and ultra-rare diseases. Located in the heart of the Cambridge, MA biotech hub, our client is driven by a mission to address significant unmet medical needs for patient populations who have long been underserved. They are seeking a visionary and experienced leader to join their executive team as the Vice President, Clinical Trial Management. This is a pivotal role that will shape the future of the company’s clinical development portfolio and directly impact the lives of patients and their families.
As the Vice President, Clinical Trial Management, you will be the strategic and operational leader responsible for the entire clinical trial management function. You will provide executive oversight for the planning, execution, and reporting of all clinical trials, from first-in-human studies through to post-marketing commitments. This role demands a leader who can not only build and inspire a world-class clinical operations team but also navigate the unique complexities and challenges inherent in rare disease drug development. You will be responsible for ensuring that all clinical programs are delivered on time, within budget, and in full compliance with the highest global quality and regulatory standards.
This position offers a unique opportunity to build and scale a critical function within a rapidly growing and well-funded organization. The ideal candidate will be a hands-on leader with a deep passion for science, a commitment to operational excellence, and a proven track record of bringing novel therapies through the clinical development lifecycle. You will be a key member of the clinical development leadership team, collaborating closely with colleagues across Research, Clinical Development, Regulatory Affairs, and Commercial to bring groundbreaking treatments from the laboratory to the patients who need them most. If you are a strategic leader eager to make a tangible difference in the rare disease space, we encourage you to apply.
Key Responsibilities of VP, Clinical Trial Management with a Rare Disease Biotech – Cambridge, MA
Strategic Leadership and Departmental Oversight
- Develop, articulate, and execute a comprehensive global clinical operations strategy that aligns with the company’s overall corporate objectives and clinical development plans.
- Provide visionary leadership to the Clinical Trial Management department, fostering a culture of accountability, innovation, collaboration, and patient-centricity.
- Establish departmental goals, key performance indicators (KPIs), and metrics to track and report on the progress and efficiency of all clinical trial activities.
- Serve as the primary clinical operations expert on the development leadership team, providing strategic input on trial design, feasibility, and operational execution.
Clinical Trial Planning and Execution
- Direct the operational execution of all clinical trials across the portfolio, ensuring seamless management from study start-up through to final clinical study report (CSR).
- Oversee the development of critical study documents, including protocols, informed consent forms, investigator brochures, and operational plans.
- Champion robust patient recruitment and retention strategies, particularly addressing the challenges of enrolling patients in rare disease populations.
- Ensure timely and effective site selection, initiation, monitoring, and close-out activities on a global scale.
Team Leadership and Development
- Recruit, train, mentor, and retain a high-performing team of clinical operations professionals (e.g., Clinical Trial Managers, CRAs, Clinical Trial Associates).
- Provide ongoing coaching and professional development opportunities to ensure the team’s skills and capabilities evolve with the company’s needs.
- Manage resource allocation, including headcount and budget, to effectively support the entire clinical development portfolio.
Vendor and CRO Management
- Lead the identification, evaluation, selection, and management of Contract Research Organizations (CROs), central labs, and other clinical trial vendors.
- Establish strong, collaborative partnerships with key vendors, setting clear expectations and performance standards.
- Oversee contract negotiations, budget development, and the management of vendor performance to ensure high-quality, on-time, and on-budget delivery of services.
Financial and Budgetary Management
- Develop and manage the annual clinical operations budget, including long-range forecasting and resource planning.
- Ensure meticulous tracking of trial-specific and departmental expenditures, providing regular updates and variance analyses to senior management.
- Drive cost-efficiency without compromising data quality or patient safety.
Quality, Compliance, and Inspection Readiness
- Guarantee that all clinical trial activities are conducted in strict accordance with relevant international and local regulations, including FDA and ICH-GCP guidelines.
- Oversee the development and maintenance of clinical operations Standard Operating Procedures (SOPs) and best practices.
- Lead and champion a state of continuous inspection readiness, preparing teams for and managing regulatory authority inspections (e.g., FDA, EMA).
Cross-Functional Collaboration
- Serve as a key collaborative partner to other functional leaders, including Clinical Science, Regulatory Affairs, Biostatistics, Data Management, Medical Affairs, and CMC.
- Ensure seamless communication and integration of clinical operations activities within broader project teams to achieve program goals.
- Represent the Clinical Trial Management function in high-level corporate meetings, governance committees, and interactions with external partners.
Requirements for the VP, Clinical Trial Management with a Rare Disease Biotech – Cambridge, MA
Educational Background
An advanced degree (M.S., Ph.D., Pharm.D., or M.D.) in a relevant life sciences or health-related field is strongly preferred. A Bachelor’s degree with extensive, directly relevant experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in clinical operations and clinical trial management within the biotechnology or pharmaceutical industry. This must include at least 5-7 years in a senior leadership capacity (e.g., Senior Director, Executive Director, VP) with direct management and team-building responsibilities.
Therapeutic Area Expertise
Deep and direct experience in the clinical development of therapies for rare or orphan diseases is an absolute requirement. Candidates must demonstrate a clear understanding of the unique operational challenges and patient engagement strategies in this space.
Global Trial Leadership
A proven and demonstrable track record of successfully leading and executing complex, multi-center, global clinical trials across all phases of development (Phase I, II, and III). Experience with post-marketing studies is a plus.
Regulatory Acumen
Expert-level knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements (FDA, EMA, etc.). Must have direct experience preparing for and participating in regulatory inspections.
Leadership and Management Skills
Exceptional leadership qualities with a demonstrated ability to build, scale, and motivate high-performing teams in a fast-paced environment. Must be a strategic thinker with strong problem-solving, decision-making, and organizational skills.
Vendor Management Expertise
Extensive experience in the full lifecycle of vendor management, from selection and qualification to contract negotiation, oversight, and performance management of CROs and other clinical service providers.
Communication and Interpersonal Skills
Outstanding written, verbal, and presentation skills. The ability to communicate complex operational information effectively to a wide range of audiences, from the project team to the Board of Directors, is essential. Strong interpersonal skills and the ability to influence and build consensus across functions are critical.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, including:
- A competitive base salary and performance-based annual bonus.
- A significant equity stake in the company through stock options, providing a meaningful opportunity for ownership.
- Comprehensive health, dental, and vision insurance plans for you and your eligible dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- A flexible and generous Paid Time Off (PTO) policy, including vacation, sick leave, and company holidays.
- Support for professional development, including attendance at industry conferences and continuing education opportunities.
- Relocation assistance may be available for highly qualified candidates.
- The opportunity to work in a dynamic, collaborative, and mission-driven culture where your contributions will have a direct and profound impact on patients’ lives.
How to Apply
If you are a driven and experienced clinical operations leader with a passion for rare diseases, we invite you to take the next step in your career. This is a chance to join a world-class team and help build a company that is changing the face of medicine for underserved patient communities.
To be considered for this exceptional opportunity, please submit your resume and a cover letter. JRG Partners specializes in connecting top-tier talent with leading companies in the life sciences sector. To learn more about our expertise and other opportunities, please visit our Life Sciences Recruiting practice area.
JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
