Marissa Volpe is an accomplished biotechnology executive whose career has been defined by a singular mission: helping bring meaningful therapies to patients and families facing serious diseases. With nearly three decades of leadership experience spanning biotechnology, biopharmaceuticals, contract research organizations (CROs), and global pharmaceutical companies, she has built a reputation for transforming complex clinical development programs into operational success. Her ability to unite scientific innovation, strategic vision, and organizational excellence has made her a respected leader in the life sciences industry, where she is recognized for developing high-performing teams, driving clinical execution, and advancing therapies that have the potential to change lives.
Currently serving as Senior Vice President of Clinical Development at NervGen Pharma, Marissa continues to lead the advancement of innovative therapies designed to address significant unmet medical needs. Prior to joining NervGen, she served as Senior Vice President and Head of Clinical Development Operations at Stoke Therapeutics, where she directed Clinical Operations, Clinical Data Management, Trial Master File (TMF), and Clinical Outsourcing. During her tenure, she successfully built and scaled a growing clinical development organization, recruited and developed exceptional talent, and partnered closely with executive leadership to align portfolio strategy with operational execution. She played an instrumental role in preparing the company for commercial readiness while supporting the strategic partnership with Biogen and overseeing the successful execution of the company’s first Phase III clinical trial, an important milestone in Stoke’s growth.
Marissa’s leadership journey reflects continuous advancement through some of the biotechnology industry’s most respected organizations, including Wave Life Sciences, Gemini Therapeutics, Curis, Sarepta Therapeutics, ImmunoGen, Sanofi Genzyme, Biogen, Novartis, Kendle, and Parexel. Beginning her career in clinical data management, she steadily expanded her responsibilities into global clinical operations, clinical development leadership, portfolio management, and executive strategy. This progression has given her an uncommon understanding of every stage of the drug development process, allowing her to bridge operational execution with long-term corporate objectives and deliver consistent results across diverse therapeutic areas.
One of Marissa’s greatest strengths is her comprehensive expertise across the full clinical development lifecycle. Her experience spans protocol development, clinical trial execution, clinical data management, outsourcing strategy, regulatory compliance, vendor management, organizational development, and commercial readiness. She understands how high-quality data, well-designed operational systems, and collaborative leadership contribute directly to successful regulatory submissions and, ultimately, improved patient outcomes. This systems-based perspective enables her to identify opportunities for greater efficiency while maintaining the highest standards of quality, compliance, and scientific integrity.
Throughout her distinguished career, Marissa has contributed to the successful development and regulatory submission of numerous groundbreaking therapies. Her work has supported major Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and New Drug Applications (NDAs), including Tysabri, Lemtrada, Aubagio, Golodirsen, and Casimersen. She has led global clinical development programs across Oncology, Neurology, Multiple Sclerosis, Ophthalmology, Immunology, Rare Genetic Diseases, and Central Nervous System disorders, consistently demonstrating her ability to manage highly complex international studies while balancing scientific innovation, operational execution, regulatory requirements, and business priorities.
As an executive leader, Marissa has consistently excelled at building organizations capable of sustaining growth and delivering excellence. She has recruited, mentored, and developed multidisciplinary teams responsible for clinical operations, data management, outsourcing, trial management, and program leadership. Her leadership philosophy emphasizes transparency, accountability, collaboration, and empowerment, creating environments where professionals can perform at their highest level. Whether managing large global organizations, overseeing multimillion-dollar budgets, or implementing new operational frameworks, she is known for fostering cultures built on trust, continuous improvement, and shared purpose.
In addition to her executive accomplishments, Marissa has demonstrated a deep commitment to education and professional development. As a Clinical Instructor within Boston University’s Graduate Medical Sciences program, she taught graduate-level courses in Clinical Trial Management, sharing practical knowledge gained through decades of industry leadership. By combining real-world case studies with academic instruction, she helped prepare future clinical research professionals to navigate the increasingly complex world of biotechnology and pharmaceutical development. Her dedication to mentoring extends beyond the classroom, as she has spent much of her career coaching emerging leaders and developing future executives within the organizations she has served.
Marissa’s experience extends well beyond the United States through the leadership of global clinical programs involving Japan, Brazil, Russia, Europe, and North America. Working across international regulatory environments has strengthened her ability to build collaborative partnerships with investigators, contract research organizations, regulators, and cross-functional teams worldwide. Her global perspective allows her to effectively balance regional execution with enterprise-wide strategy, ensuring that complex multinational studies are conducted with consistency, quality, and operational excellence.
Her outstanding leadership has earned recognition through several prestigious industry honors, including the Genzyme Alpine Award, the Genzyme Vice Presidents Award, the Team Breakthrough Award, and multiple Spot Awards recognizing exceptional leadership, innovation, teamwork, and execution. These recognitions reflect both her technical expertise and her ability to inspire teams to achieve ambitious objectives while maintaining an unwavering focus on patients and scientific excellence.
Outside of her executive responsibilities, Marissa remains deeply committed to making a positive impact beyond the workplace. She currently serves on the board of SyncUp and is passionate about supporting children living with serious diseases. She also enjoys therapeutic volunteer work, traveling internationally, attending concerts, and spending meaningful time with family and friends. These personal interests reinforce the empathy, compassion, and service-oriented mindset that have consistently shaped both her leadership style and her professional mission.
As she seeks additional board opportunities, Marissa brings an exceptional combination of operational leadership, governance experience, clinical development expertise, and strategic insight. Having regularly partnered with executive leadership teams and presented to Boards of Directors throughout her career, she understands how effective governance can accelerate innovation while managing risk and driving long-term organizational success. Her ability to connect scientific strategy with operational execution, combined with her passion for mentoring leaders and improving patient outcomes, positions her as an outstanding advisor for biotechnology, pharmaceutical, and healthcare organizations seeking experienced board leadership.
Character:
Marissa demonstrates unwavering integrity, compassion, and humility in every aspect of her leadership, always placing patients, people, and purpose at the center of her decisions. She builds trust by leading with authenticity, supporting her teams, and fostering environments where collaboration and accountability thrive.
Knowledge:
With nearly 30 years of experience across biotechnology, pharmaceuticals, and clinical research, Marissa possesses exceptional expertise in clinical development, drug development, clinical operations, regulatory strategy, and organizational leadership. Her comprehensive understanding of the entire clinical development lifecycle enables her to provide thoughtful guidance that balances scientific innovation with operational excellence.
Strategic:
Marissa consistently aligns long-term corporate strategy with disciplined operational execution, enabling organizations to accelerate development while maintaining quality, compliance, and fiscal responsibility. She understands how to scale organizations, build infrastructure, and position innovative companies for sustained growth and successful commercialization.
Communication:
An engaging and confident communicator who effectively translates complex scientific and operational concepts for executive leadership, Boards of Directors, and cross-functional teams. She believes that clear, transparent communication strengthens organizations, builds trust, and empowers individuals to perform at their highest level.
