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# Director of Clinical Trials


Role Overview for Director of Clinical Trials
JRG Partners is proud to partner with a prominent, innovative pharmaceutical company, a leader in its therapeutic area, located in the vibrant biotech hub of Boston, MA. We are seeking an exceptional and highly accomplished Director of Clinical Trials, a pivotal senior leadership role often referred to as Director of Clinical Operations. This is a high-stakes, high-impact position within the dynamic pharmaceutical, biotechnology, and medical device industries, demanding a unique blend of scientific acumen, strategic foresight, and operational excellence.
The successful candidate will be instrumental in shaping the future of medicine, directly overseeing the comprehensive execution, strategic planning, and meticulous management of clinical studies. The ultimate goal is to rigorously assess and validate the safety and efficacy of novel drugs, biologics, and medical devices, ensuring they meet the highest global regulatory and ethical standards before reaching patients who desperately need them.
As the Director of Clinical Trials, you will be a visionary leader, driving the clinical development pipeline from conceptualization through late-stage trials. You will be responsible for translating ambitious scientific goals into executable clinical strategies, navigating complex regulatory landscapes, and fostering a culture of scientific rigor, compliance, and innovation.
This role requires a leader who can inspire and manage cross-functional teams, cultivate strong relationships with key stakeholders, and adeptly manage resources and budgets to deliver trials on time and within scope. Your expertise will directly influence critical go/no-go decisions, impacting the company’s portfolio and, most importantly, the lives of patients worldwide. If you are a seasoned clinical trials professional with a proven track record of leadership, strategic thinking, and a passion for advancing healthcare, we invite you to explore this unparalleled opportunity to make a significant and lasting contribution.
Key Responsibilities of Director of Clinical Trials
The Director of Clinical Trials will assume comprehensive oversight and strategic leadership across all phases of clinical development. Your responsibilities will encompass, but not be limited to, the following critical areas:
Strategic Planning & Program Oversight
Develop, implement, and continually refine clinical development plans and strategies that align with the company’s overall scientific and business objectives. Provide expert guidance and strategic direction for all clinical trial programs, ensuring efficient progression from early-stage to late-stage development and post-market studies.
Operational Excellence & Execution
Lead and manage the operational aspects of multiple clinical trials, ensuring their successful execution from study startup to closeout. This includes meticulous planning, resource allocation, timeline management, and proactive risk mitigation strategies to ensure trials are delivered on schedule and within budget.
Regulatory Compliance & Quality Assurance
Ensure all clinical trial activities strictly adhere to global regulatory requirements, including FDA regulations, EMEA guidelines, and, critically, adherence to rigorous ICH-GCP guidelines. Implement robust quality assurance processes and conduct regular audits to maintain the highest standards of data integrity and patient safety.
Team Leadership & Development
Recruit, mentor, develop, and manage a high-performing team of clinical operations professionals, including Clinical Project Managers, Clinical Trial Managers, and Clinical Research Associates. Foster a collaborative, results-oriented, and continuous learning environment.
Budget & Resource Management
Develop and manage comprehensive clinical trial budgets, ensuring fiscal responsibility and optimal resource utilization. Oversee vendor selection and management, including Contract Research Organizations (CROs), central labs, and other external service providers, negotiating contracts and monitoring performance.
Protocol Development & Review
Provide scientific and operational input into the design, development, and review of clinical trial protocols, investigator brochures, informed consent forms, and other essential study documents. Ensure scientific validity, ethical considerations, and operational feasibility.
Data Management & Analysis Oversight
Collaborate closely with biostatistics and data management teams to ensure the integrity, accuracy, and timely availability of clinical trial data. Participate in the interpretation of study results and contribute to clinical study reports and regulatory submissions.
Cross-functional Collaboration
Serve as a key liaison and collaborate effectively with internal departments such as Research & Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Commercial teams to ensure seamless integration and alignment of clinical trial activities.
Stakeholder Communication
Represent the company in interactions with regulatory authorities, ethics committees, key opinion leaders, investigators, and other external partners. Effectively communicate complex clinical information and trial progress to various internal and external stakeholders.
Risk Management & Problem Solving
Proactively identify potential risks to clinical trial success and develop effective mitigation strategies. Demonstrate strong problem-solving skills to address unforeseen challenges and ensure trial continuity.
Requirements for the Director of Clinical Trials
To excel in this demanding yet highly rewarding role, candidates must possess a profound blend of academic achievement, extensive industry experience, and exceptional leadership capabilities. Our ideal candidate will demonstrate a relentless commitment to scientific excellence, patient safety, and regulatory integrity.
Education
A PhD or MD in a relevant scientific or medical discipline is strongly preferred. A Master’s degree in Clinical Research, Life Sciences, Public Health, or a related field is required.
Experience
A minimum of 10-12 years of progressive experience in clinical research and clinical operations within the pharmaceutical, biotechnology, or medical device industries. This must include at least 5-7 years in a senior leadership or management role, overseeing multiple clinical trials or programs.
Industry Knowledge
Demonstrated expertise across various therapeutic areas (e.g., Oncology, Neurology, Immunology, Rare Diseases) is highly advantageous.
Regulatory Expertise
In-depth, hands-on knowledge of global regulatory requirements and guidelines, including FDA regulations (e.g., 21 CFR Parts 11, 50, 54, 56, 312, 812), European Medicines Agency (EMA) directives, and meticulous adherence to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
Leadership & Management
Proven track record of successfully leading, motivating, and developing large, diverse clinical operations teams. Experience in managing and mentoring direct reports and fostering a high-performance culture.
Strategic Acumen
Ability to think strategically, anticipate challenges, and develop innovative solutions. Demonstrated experience in contributing to or developing clinical development plans.
Project Management
Exceptional project management skills, including the ability to manage complex timelines, budgets, and resources across multiple concurrent studies. PMP certification is a plus.
Vendor Management
Extensive experience in selecting, overseeing, and managing Contract Research Organizations (CROs) and other third-party vendors, including contract negotiation and performance monitoring.
Communication Skills
Superior verbal and written communication skills, with the ability to present complex scientific and operational information clearly and concisely to diverse audiences, including senior leadership, regulatory bodies, and external partners.
Problem-Solving
Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving issues.
Travel
Ability to travel domestically and internationally as required (approximately 15-25%).
Benefits & Perks Offered
Our client believes in investing in its people, recognizing that their success is the foundation of the company’s innovation and impact. As the Director of Clinical Trials, you will be offered a comprehensive and highly competitive benefits package designed to support your professional growth, personal well-being, and financial security. This includes:
Competitive Compensation
An attractive base salary commensurate with your experience and expertise, along with a robust annual performance-based bonus program and potential long-term incentive plans.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your family, with low deductibles and comprehensive coverage. Access to wellness programs, employee assistance programs, and mental health resources.
Retirement Planning
A generous 401(k) retirement savings plan with a substantial company match, designed to help you build a secure financial future.
Paid Time Off
A generous accrual of paid time off (PTO), including vacation, sick leave, and company-paid holidays, ensuring a healthy work-life balance.
Professional Development
Significant opportunities for continuous learning, professional development, and career advancement. This includes support for attending industry conferences, workshops, and further education to keep you at the forefront of clinical research.
Life & Disability Insurance
Company-paid life insurance, short-term, and long-term disability coverage.
Relocation Assistance
For qualified candidates, comprehensive relocation assistance will be provided to facilitate a smooth transition to the vibrant Boston area.
Innovative Work Environment
Join a collaborative, intellectually stimulating, and supportive culture where your contributions are valued, and innovation is celebrated. Work alongside some of the brightest minds in the pharmaceutical industry, making a tangible difference in patient lives.
On-site Amenities
Access to state-of-the-art facilities, including modern office spaces, on-site fitness centers, and healthy dining options.
How to Apply
If you are a highly motivated and experienced leader ready to take on a pivotal role in advancing groundbreaking therapies, we encourage you to apply. This exceptional opportunity to join a leading pharmaceutical company in Boston, MA, is being exclusively managed by JRG Partners, a premier executive search firm specializing in the life sciences industry.
To express your interest and be considered for this Director of Clinical Trials position, please submit your resume and a cover letter detailing your qualifications and relevant experience through our confidential portal. In your cover letter, please highlight your most significant achievements in clinical trial leadership and your vision for contributing to our client’s success.
JRG Partners is committed to diversity and inclusion. We encourage all qualified candidates to apply. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
Explore more executive opportunities in Clinical Research & Development with JRG Partners.