Position Summary
The Senior Vice President of Regulatory Affairs and Quality is a member of Verastem Oncology's leadership team and provides enterprise-wide leadership for global regulatory strategy and product quality. Working closely with the President of Development, this leader will define and execute an integrated vision that supports development, approval, commercialization, and compliant lifecycle management of Verastem's small molecule portfolio.
The role oversees global regulatory activities, primarily in the United States, European Union, and Japan, while engaging with other health authorities as needed. It also leads strategic, tactical, and operational product quality oversight, ensuring that activities across the portfolio align with Verastem policies, applicable GxP and GMP requirements, and evolving global expectations. Near term US initiatives include LGSOC 1L and PDAC and CRC submissions in quick succession.
This executive will connect strategy with execution across Regulatory Affairs, Quality, CMC, Clinical Development, Clinical Operations, Safety & Pharmacovigilance, and other functions. The successful candidate will build strong teams, strengthen global infrastructure and processes, and create an environment in which sound judgment, innovation, collaboration, and timely, high-quality execution thrive.
Key Responsibilities
Global Regulatory Strategy and Execution
- Develop and implement global regulatory strategies that support efficient development, submission, approval, commercialization, and lifecycle management.
- Provide leadership for regulatory strategies and activities in the United States, European Union, and Japan, incorporating additional regions as appropriate and minimizing avoidable lag time between regional submissions and approvals.
- Guide regulatory strategy across clinical development, CMC, safety, and other product lifecycle activities, providing clear recommendations on complex regulatory and business challenges.
- Ensure the timely, high-quality preparation, review, and delivery of global regulatory submissions and responses to health authority questions and commitments.
- Improve regulatory infrastructure and processes to support efficient use of resources and the potential for simultaneous or closely sequenced solid tumor and international submissions.
- Ensure regulatory activities, processes, and submissions comply with applicable local and international laws, standards, guidelines, and commitments.
- Provide oversight, as applicable, for regulatory intelligence, promotional and non-promotional material review, and regulatory support for market access and business conduct activities.
Global Product Quality and Compliance
- Lead the global quality strategy for Verastem's small molecule portfolio, integrating strategic, tactical, and operational quality oversight across development, launch, commercialization, and lifecycle management.
- Ensure quality activities align with Verastem policies and applicable GxP and GMP requirements, and promote consistent compliance practices across products and external partners.
- Facilitate effective execution among business partners, the CMC, Clinical Development, Clinical Operations, Regulatory Affairs, and the Quality organization, ensuring clear ownership, timely decisions, and aligned portfolio priorities.
- Support internal audits and certifications and provide oversight for external audits of contract manufacturing organizations and other relevant business partners.
- Establish and maintain a state of inspection readiness across the organization, ensuring continued compliance for commercial products while proactively preparing the company, its systems, and external partners for regulatory submission and pre-approval inspections associated with upcoming product filings.
- Guide quality strategy and implementation for combination products as applicable, and incorporate emerging products, technologies, including use of AI, and regulatory expectations into portfolio plans.
Cross Functional Partnership and External Leadership
- Build strong partnerships across Regulatory Affairs, Quality, Clinical Development, Clinical Operations, Safety, Pharmacovigilance, Manufacturing, and other functions to advance near-term milestones and enterprise objectives.
- Interpret international regulations and emerging quality expectations, develop a clear company point of view, and lead cross-functional action when changes affect Verastem's products or business.
- Represent Verastem with health authorities, industry groups, external forums, and other stakeholders, advocating for the company's interests and helping shape the broader regulatory and quality environment.
- Partner with industry leaders, where appropriate and in a precompetitive manner, to address policy and technical issues affecting the biopharmaceutical sector.
Qualifications
- Bachelor's degree in a scientific, technical, or other relevant field required; an advanced degree such as an MS, PharmD, PhD, MD, or equivalent is preferred.
- At least 20 years of progressively responsible experience in Regulatory Affairs, Quality, or closely related biopharmaceutical functions, including significant senior leadership experience.
- Demonstrated success developing and executing global regulatory strategies across the product lifecycle, with substantial experience in the United States and working knowledge of European Union, Japanese, ICH, and other international requirements.
- Deep knowledge of GxP and GMP principles and experience providing product quality oversight for small molecule products across development and commercial stages.
- Experience leading major regulatory submissions, health authority interactions, product specification strategies, and post-approval commitments.
- Working knowledge of quality systems, product quality review and trending, external manufacturing oversight, audits, and inspection readiness; combination product or device experience is an advantage.
- Proven ability to build, inspire, and retain high-performing, diverse teams and to develop leaders who succeed in a fast-paced, evolving environment. Experience building a culture of urgency, collaboration and quality.
- Strong business judgment and a record of translating complex regulatory and quality requirements into practical, risk-based strategies and clear organizational priorities.
- Exceptional written and verbal communication, stakeholder management, influencing, and negotiation skills, with evidence of positive outcomes across internal and external relationships.
- Demonstrated ability to contribute as a company executive, improve cross-functional effectiveness, lead change, and drive corporate success.
Leadership Profile
You are an inspiring, pragmatic leader committed to patients, product quality, and scientific excellence. You combine strategic vision with disciplined execution, , optimizes use of technology create clarity in complex situations, and develop people through trust, coaching, and accountability. You are decisive and execute swiftly, build productive relationships across organizational boundaries and bring an innovative, continuous-improvement mindset to regulatory and quality challenges.
