Role Overview for VP Clinical Operations – Boston, MA
JRG Partners is exclusively representing a pioneering, clinical-stage biopharmaceutical company at the forefront of developing novel therapeutics for challenging diseases. Based in the vibrant biotech hub of Boston, MA, our client is driven by a passion for science and a commitment to improving patient outcomes. They are seeking a visionary and experienced Vice President of Clinical Operations to join their dynamic executive team. This is a pivotal leadership role responsible for providing strategic direction and operational oversight for all clinical development programs. Reporting directly to the Chief Medical Officer, the VP of Clinical Operations will be instrumental in shaping the company’s clinical strategy, building a world-class clinical operations team, and ensuring the successful execution of all clinical trials from Phase I through to regulatory submission and commercialization. The ideal candidate is a strategic thinker with a hands-on approach, capable of navigating the complexities of global clinical development while fostering a culture of excellence, innovation, and urgency. This individual will serve as a key member of the leadership team, contributing to the overall corporate strategy and playing a critical role in the company’s growth and success. You will be the architect of the clinical operations function, responsible for scaling the team, implementing robust systems and processes, and driving programs forward to meet critical milestones.
Key Responsibilities of VP Clinical Operations – Boston, MA
The Vice President of Clinical Operations will have a broad range of responsibilities, encompassing strategic planning, operational execution, team leadership, and financial stewardship. Key duties include:
Strategic Leadership and Planning
Develop and execute the long-term strategic vision for the Clinical Operations department, ensuring alignment with corporate goals and the overall clinical development plan. Provide expert operational input into the design and implementation of all clinical trial protocols, amendments, and related documents. Proactively identify and mitigate risks to clinical program timelines, budgets, and quality.
Clinical Trial Oversight and Execution
Assume ultimate accountability for the planning, execution, and completion of all clinical trials on time and within budget. This includes oversight of study start-up, site selection, patient recruitment and retention strategies, data collection, and study close-out activities. Ensure that all clinical trials are conducted in accordance with the highest ethical and quality standards.
Vendor and CRO Management
Lead the selection, negotiation, and management of Contract Research Organizations (CROs), central labs, and other clinical trial vendors. Establish strong partnerships and performance metrics to ensure vendors deliver high-quality results and meet contractual obligations. Provide rigorous oversight of all outsourced activities.
Team Development and Leadership
Build, lead, mentor, and inspire a high-performing Clinical Operations team. Foster a collaborative, accountable, and results-oriented culture. Oversee the hiring, training, and professional development of all clinical operations staff, including Clinical Trial Managers, CRAs, and Clinical Project Associates.
Regulatory Compliance and Quality Assurance
Ensure all clinical trial activities are conducted in strict adherence to regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and other global regulations. Oversee the development and implementation of Standard Operating Procedures (SOPs) for the clinical operations function. Prepare for and participate in regulatory inspections and internal audits.
Financial Management
Develop, manage, and forecast comprehensive budgets for all clinical programs. Track spending against budget, identify variances, and implement corrective actions as needed. Ensure efficient allocation and utilization of resources to maximize value.
Cross-Functional Collaboration
Serve as a key liaison and foster strong collaborative relationships with other functional areas, including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Medical Affairs, and Project Management. Ensure seamless communication and integration of clinical operations activities across the organization.
Process Improvement and Innovation
Drive continuous improvement initiatives within the Clinical Operations department. Champion the evaluation and implementation of new technologies, systems, and methodologies to enhance the efficiency and effectiveness of clinical trial execution.
Requirements for the VP Clinical Operations – Boston, MA
The successful candidate will be a seasoned and accomplished leader with a proven track record of success in leading clinical operations within the biopharmaceutical industry. The specific qualifications include:
Education
An advanced degree (M.S., Ph.D., Pharm.D., or M.D.) in a scientific or health-related field is strongly preferred. A Bachelor’s degree with extensive, relevant experience will be considered.
Experience
A minimum of 15 years of progressive experience in clinical operations within the pharmaceutical, biotechnology, or CRO industry. At least 7 years of experience in a senior leadership role (e.g., Senior Director, Executive Director) with direct management responsibility for a clinical operations team.
Therapeutic Expertise
Significant experience managing clinical trials in complex therapeutic areas such as oncology, immunology, or rare diseases is highly desirable.
Global Trial Management
Demonstrated experience in successfully managing global, multi-center clinical trials across all phases of development (Phase I-IV).
Regulatory Expertise
Deep and thorough understanding of the drug development process, FDA regulations, ICH guidelines, and global GCP standards. Experience with preparing for and participating in regulatory inspections is required. Experience with NDA/BLA/MAA submissions is a significant plus.
Leadership Skills
Proven ability to lead, influence, and motivate teams. A track record of building and developing high-performing clinical operations departments. Exceptional strategic thinking, problem-solving, and decision-making capabilities.
Communication Skills
Outstanding written and verbal communication skills. Ability to effectively present complex information and strategies to executive leadership, boards of directors, and external partners.
Vendor Management
Extensive experience in selecting, managing, and overseeing CROs and other clinical vendors, including budget negotiation and performance management.
Personal Attributes
A high level of integrity, a strong work ethic, and a sense of urgency. Must be adaptable and able to thrive in a fast-paced, dynamic, and collaborative small-company environment.
Benefits & Perks Offered
Our client offers a highly competitive compensation and benefits package designed to attract and retain top talent. This includes:
Competitive Compensation
A highly attractive base salary, a significant annual performance-based bonus, and a substantial equity package (stock options) providing a meaningful stake in the company’s success.
Comprehensive Health and Wellness
Top-tier medical, dental, and vision insurance for you and your dependents. A robust wellness program, including gym membership reimbursement and mental health resources.
Retirement Savings
A 401(k) retirement 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 days, and company-paid holidays. Flexible work arrangements to support a healthy work-life integration.
Professional Growth
A dedicated budget for professional development, including attendance at industry conferences, workshops, and continuing education courses. Clear opportunities for career advancement within a growing organization.
Additional Perks
Commuter benefits, regular team-building events, and a collaborative and inspiring office environment located in the heart of Boston’s biotech community.
How to Apply
JRG Partners is proud to be the exclusive recruitment partner for this confidential search. We are seeking a transformative clinical operations leader who is passionate about science and dedicated to bringing life-changing therapies to patients. If you possess the required skills, experience, and drive to excel in this pivotal role, we invite you to submit your application for consideration. To learn more about our specialized recruitment services in this sector, please visit the JRG Partners’ Clinical Research Recruiters practice area page. Qualified candidates are encouraged to apply by submitting a comprehensive resume and a cover letter detailing their qualifications and interest in the position.
