Role Overview for VP, Clinical Data Management with a Biopharma Firm – Cambridge, MA
JRG Partners is proud to partner with a pioneering, clinical-stage biopharmaceutical company based in the heart of innovation, Cambridge, MA. Our client is dedicated to developing transformative therapies for patients with serious and life-threatening diseases. As they advance their robust pipeline, they are seeking a visionary and strategic executive to join their leadership team as the Vice President of Clinical Data Management. This is a paramount role responsible for providing executive leadership, strategic direction, and operational oversight for the entire clinical data management function across the organization’s portfolio.
The VP, Clinical Data Management will be the ultimate steward of the company’s clinical trial data, the most critical asset in drug development. This individual will build and lead a world-class data management organization, establishing the vision, infrastructure, and processes necessary to ensure the highest standards of data integrity, quality, and regulatory compliance. You will be instrumental in shaping the company’s data strategy, driving innovation, and implementing cutting-edge technologies and methodologies to optimize data collection, processing, and analysis.
This role requires a leader who can operate at a high strategic level while also possessing a deep, hands-on understanding of the tactical aspects of data management. You will be a key member of the clinical development leadership team, collaborating closely with peers in Clinical Operations, Biostatistics, Regulatory Affairs, and Pharmacovigilance to ensure the successful execution of clinical programs and support timely, high-quality regulatory submissions. This is a unique opportunity to make a significant impact on a growing organization and, ultimately, on the lives of patients waiting for new treatments.
Key Responsibilities of VP, Clinical Data Management with a Biopharma Firm – Cambridge, MA
The Vice President of Clinical Data Management will be accountable for a wide range of strategic and operational duties, including but not limited to:
Strategic Leadership and Departmental Vision
Develop and execute a comprehensive, long-term strategy for the Clinical Data Management department that aligns with the company’s overall clinical development and corporate goals. Establish departmental vision, mission, and objectives, and champion a culture of excellence, quality, and continuous improvement.
Operational Oversight and Execution
Provide executive oversight for all clinical data management activities from study start-up through database lock and final archival. This includes protocol review, CRF/eCRF design, EDC system selection and implementation, data validation specifications, query management, medical coding, SAE reconciliation, and data cleaning processes for all phases of clinical trials.
Team Leadership and Talent Development
Build, lead, mentor, and develop a high-performing team of clinical data management professionals. Foster a collaborative, innovative, and inclusive team environment. Responsible for resource planning, allocation, and performance management to meet the demands of a dynamic and growing clinical portfolio.
Process and Technology Innovation
Stay at the forefront of industry trends and technological advancements in data management. Drive the evaluation and implementation of new systems, tools, and methodologies (e.g., AI/ML, decentralized trial data sources, risk-based data management) to enhance efficiency, data quality, and analytical capabilities.
Vendor and CRO Management
Lead the selection, qualification, and management of data management vendors, CROs, and technology partners. Establish robust oversight models, define key performance indicators (KPIs), and ensure vendors deliver high-quality data on time and within budget. Negotiate contracts and manage departmental budgets effectively.
Regulatory Compliance and Quality Assurance
Ensure all data management activities, systems, and documentation are conducted in strict compliance with GCP, ICH guidelines, and global regulatory requirements, including the critical standards of FDA 21 CFR Part 11. Oversee the development and maintenance of SOPs, work instructions, and other controlled documents. Act as the primary data management contact for regulatory inspections and audits.
Cross-Functional Collaboration
Serve as a key strategic partner to other functional heads within Clinical Development, including Clinical Operations, Biostatistics, Programming, Medical Affairs, and Regulatory Affairs. Ensure seamless data flow and clear communication channels to support integrated and efficient trial execution and analysis.
Data Standards Governance
Champion and oversee the development and implementation of company-wide data standards, adhering to CDISC models (SDTM, ADaM, CDASH) to ensure data consistency, interoperability, and readiness for regulatory submission and integrated analyses.
Requirements for the VP, Clinical Data Management with a Biopharma Firm – Cambridge, MA
The ideal candidate will be a seasoned and accomplished leader with a proven track record of success in the biopharmaceutical industry. Specific qualifications include:
Educational Background
An advanced degree (M.S., M.P.H., Ph.D., or equivalent) in a scientific, life sciences, or related field is required.
Professional Experience
A minimum of 15 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry. A minimum of 7 years of experience in a senior leadership capacity (e.g., Director, Senior Director, Executive Director) with direct responsibility for managing teams, budgets, and departmental strategy is essential.
Leadership and Management Skills
Demonstrated ability to build and lead high-performing teams. Proven experience in mentoring and developing staff. Exceptional strategic thinking, problem-solving, and decision-making capabilities.
Technical Expertise
Deep, expert-level knowledge of all phases of clinical data management processes. Extensive experience with major EDC systems (e.g., Medidata Rave, Veeva Vault EDC, Oracle Clinical) and other clinical trial technologies. Profound understanding and practical application of CDISC standards (SDTM, CDASH) are mandatory.
Regulatory Acumen
Comprehensive knowledge of ICH/GCP guidelines and global regulatory requirements (FDA, EMA, etc.). Experience supporting successful NDA/BLA/MAA submissions and participating in regulatory inspections is highly preferred.
Communication and Interpersonal Skills
Superior verbal and written communication skills. The ability to articulate complex concepts clearly and concisely to a variety of audiences, from technical staff to executive leadership. Proven ability to influence and build strong collaborative relationships with internal and external stakeholders.
Therapeutic Experience
While not strictly required, experience in therapeutic areas such as oncology, immunology, neurology, or rare diseases is highly advantageous.
Personal Attributes
A proactive, results-oriented leader with high ethical standards, integrity, and a strong sense of urgency. Must be adaptable and able to thrive in a fast-paced, dynamic, and scientifically-driven environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package. This includes:
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and a significant long-term incentive package (stock options/equity).
Comprehensive Health and Wellness
A full suite of benefits including medical, dental, and vision insurance for you and your dependents, with low employee premiums. Includes access to wellness programs, mental health support, and an Employee Assistance Program (EAP).
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A competitive paid time off (PTO) policy, including vacation, sick days, and company-paid holidays to support a healthy work-life balance.
Professional Development
A dedicated budget for professional development, including attendance at industry conferences, workshops, and continuing education courses.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates who are not local to the Cambridge area.
Additional Perks
Commuter benefits, on-site amenities, and regular company-sponsored social events to foster a strong and collaborative community.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a transformative data management leader ready to take on a pivotal executive role at a company poised for significant growth and success, we encourage you to apply. Please submit your resume and a cover letter detailing your qualifications and interest in the position. JRG Partners is committed to diversity and inclusion and is an equal opportunity employer. We welcome all qualified applicants to apply. For confidential consideration, please direct your application to our specialized recruitment team. You may also wish to learn more about our firm by exploring other opportunities within our Life Sciences and Biotechnology practice.
