Role Overview for EVP, Global Clinical Development with a Biopharma Start-up – Cambridge, MA
JRG Partners is proud to partner with a pioneering, well-funded biopharmaceutical start-up poised to redefine the treatment landscape in its therapeutic area. Located in the heart of the biotech ecosystem in Cambridge, MA, our client is built on a foundation of groundbreaking science and a commitment to addressing significant unmet medical needs.
They are seeking a visionary and experienced Executive Vice President (EVP), Global Clinical Development to join their executive leadership team. This is a rare opportunity to shape the future of a dynamic organization, build a world-class clinical development function from the ground up, and steward novel therapies from early clinical investigation through to global regulatory approval and commercialization.
As the EVP, Global Clinical Development, you will be the single point of accountability for all aspects of the company’s clinical strategy and execution. You will serve as a key member of the executive team, contributing to the overall corporate strategy and vision. This role requires a strategic leader with a deep understanding of the science, a proven track record of successful drug development, and the entrepreneurial spirit to thrive in a fast-paced, innovative start-up environment.
You will be responsible for designing and implementing comprehensive clinical development plans, building and mentoring a high-performing team, and ensuring all clinical activities are conducted with the highest standards of scientific rigor, ethical conduct, and regulatory compliance. The ideal candidate is a physician-scientist with extensive experience leading clinical programs through all phases of development, possessing the gravitas and expertise to represent the company before regulatory agencies, key opinion leaders (KOLs), and the investment community.
Key Responsibilities of EVP, Global Clinical Development with a Biopharma Start-up – Cambridge, MA
The EVP, Global Clinical Development will have a broad and impactful remit, overseeing the entire clinical development lifecycle. Key responsibilities include:
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Strategic Clinical Leadership
Develop and execute the overarching global clinical development strategy for the company’s portfolio. Author and oversee the creation of comprehensive, integrated clinical development plans (CDPs), target product profiles (TPPs), and protocols that are innovative, efficient, and aligned with corporate goals. Provide critical input into the broader R&D and corporate strategy, including portfolio management, lifecycle management, and business development evaluations.
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Program Execution and Oversight
Provide hands-on leadership for the design, execution, and interpretation of all clinical trials (Phase I-IV). Ensure trials are conducted on time, within budget, and in full compliance with GCP, ICH guidelines, and global regulatory requirements. Proactively identify and mitigate risks to clinical program timelines, budgets, and quality. You will be responsible for the integrity and success of all global clinical trials under your purview.
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Organizational Leadership and Team Development
Recruit, build, and lead a world-class global clinical development organization, including clinical operations, clinical science, biostatistics, data management, and drug safety/pharmacovigilance. Foster a culture of scientific excellence, innovation, collaboration, and urgency. Mentor and develop team members, providing guidance and opportunities for professional growth.
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Regulatory Strategy and Interaction
Lead the development and execution of the global regulatory strategy. Serve as the primary clinical representative in interactions with health authorities worldwide, including the FDA, EMA, and others. Lead the preparation and authoring of key regulatory documents, including INDs, CTAs, briefing documents, NDAs/BLAs, and responses to regulatory agency inquiries.
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Medical and Scientific Oversight
Provide rigorous medical monitoring and safety oversight for all clinical trials. Ensure the highest standards of patient safety are maintained across the portfolio. Lead the analysis and interpretation of clinical trial data, and oversee the preparation of clinical study reports, publications, and presentations for scientific congresses.
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Cross-Functional Collaboration
Work in close partnership with colleagues on the executive team and across all functions, including Research, Preclinical Development, CMC, Commercial, and Medical Affairs. Ensure seamless integration of clinical development activities with the broader organizational objectives. Serve as the primary clinical voice in internal governance committees and external partnerships.
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External Engagement and Communication
Cultivate and maintain strong relationships with leading academic researchers, clinical investigators, and KOLs. Represent the company and its clinical programs at scientific meetings, investor conferences, and partnering discussions. Effectively communicate clinical trial results and program milestones to both internal and external stakeholders.
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Fiscal and Resource Management
Develop and manage the annual budget for the clinical development organization. Ensure prudent allocation of resources to achieve program goals. Oversee the selection and management of CROs, central labs, and other clinical vendors, ensuring high-quality performance and accountability.
Requirements for the EVP, Global Clinical Development with a Biopharma Start-up – Cambridge, MA
We are seeking a seasoned and accomplished leader with the following qualifications:
Education
An M.D. is required. A Ph.D. (M.D./Ph.D.) is highly preferred. Board certification in a relevant specialty (e.g., Oncology, Immunology, Hematology, Neurology) is a significant asset.
Experience
A minimum of 15+ years of progressive experience in clinical development within the biopharmaceutical industry. A proven track record of successfully leading clinical programs from IND to NDA/BLA submission and approval is essential. Experience in a start-up or small biotech environment is highly desirable.
Leadership
Demonstrated experience building and leading high-performing, multi-disciplinary clinical development teams. Must possess exceptional leadership, influencing, and management skills with the ability to inspire and motivate others.
Regulatory Expertise
Deep, hands-on experience with global regulatory authorities, particularly the FDA and EMA. Must have direct experience leading regulatory filings and participating in key health authority meetings.
Scientific Acumen
Strong scientific background and the ability to critically evaluate and interpret preclinical and clinical data. Must be able to engage in deep scientific discussions with internal and external experts.
Strategic Thinking
Proven ability to think strategically and translate corporate objectives into actionable clinical development and regulatory plans. Must be adept at navigating complexity and ambiguity.
Communication Skills
Exceptional written and verbal communication skills. Must be capable of presenting complex scientific and clinical information clearly and concisely to a wide range of audiences, from scientific experts to board members and investors.
Personal Attributes
High level of integrity, a strong sense of urgency, and a results-oriented mindset. Must be a collaborative team player with a hands-on, ‘roll-up-the-sleeves’ attitude appropriate for a start-up culture.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and long-term incentives.
Meaningful Equity
A substantial equity stake (stock options) in the company, providing the opportunity to share directly in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance for you and your eligible dependents.
Retirement Savings
A 401(k) plan with a generous company match to help you save for the future.
Generous Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays.
Professional Development
Support for attending scientific conferences, continuing education, and other professional development activities.
State-of-the-Art Workplace
A collaborative and dynamic work environment located in a modern facility in Cambridge, MA.
Relocation Assistance
A comprehensive relocation package is available for the right candidate.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a transformative clinical development leader ready to make a lasting impact on a promising biopharma company, we encourage you to apply. To express your interest, please submit your CV and a cover letter detailing your qualifications and motivation for the role.
For more information about our expertise in this sector, please visit our Life Sciences and Healthcare practice area page. We look forward to reviewing your application. All inquiries and applications will be handled with the strictest confidence.
