Role Overview for EVP, Global Drug Safety with a Biopharma Firm – Cambridge, MA
JRG Partners is proud to announce an exclusive executive search for an Executive Vice President (EVP), Global Drug Safety on behalf of our client, a pioneering, commercial-stage biopharmaceutical company headquartered in the vibrant life sciences hub of Cambridge, MA. This is a career-defining opportunity for a visionary leader to assume ultimate responsibility for the global pharmacovigilance and risk management strategy across the company’s entire portfolio of innovative therapies.
As the EVP, Global Drug Safety, you will be a pivotal member of the executive leadership team, reporting directly to the Chief Medical Officer. You will be entrusted with building, leading, and inspiring a world-class global drug safety organization. Your strategic direction will ensure the highest standards of patient safety, regulatory compliance, and scientific integrity are maintained and exceeded across all clinical development and post-marketing activities. This role demands a unique blend of deep scientific and medical expertise, extensive regulatory knowledge, and exceptional executive leadership capabilities. You will be the organization’s foremost authority on pharmacovigilance, shaping policies, processes, and a culture of proactive safety surveillance and risk mitigation. This position offers the chance to make a profound impact on patient lives by ensuring the safety and optimal benefit-risk profile of groundbreaking medicines that address significant unmet medical needs. You will be at the forefront of medical innovation, navigating the complex global regulatory landscape and providing the strategic oversight necessary to support the company’s continued growth and success.
Key Responsibilities of EVP, Global Drug Safety with a Biopharma Firm – Cambridge, MA
The EVP, Global Drug Safety will have a broad and impactful remit, encompassing strategic leadership, operational excellence, and cross-functional collaboration. Your core responsibilities will include:
Strategic Leadership & Vision
Develop and execute a comprehensive, forward-thinking global pharmacovigilance (PV) and risk management strategy that aligns with the company’s corporate objectives and long-term vision. Provide executive oversight for all drug safety functions, including operations, signal detection, risk management, safety systems, and compliance.
Global PV Operations Oversight
Ensure the efficient, effective, and compliant management of global PV operations. This includes oversight of individual case safety report (ICSR) processing, aggregate report production (e.g., PADERs, PSURs/PBRERs, DSURs), literature screening, and safety data exchange agreements (SDEAs) with partners.
Signal Detection & Risk Management
Lead the strategy for proactive signal detection, evaluation, and validation. Oversee the development, implementation, and assessment of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) for all products. Chair high-level safety governance committees to ensure timely and robust decision-making on safety issues.
Regulatory Compliance & Inspection Readiness
Serve as the ultimate point of accountability for ensuring that all PV activities are conducted in full compliance with global regulatory requirements, including those of the FDA, EMA, PMDA, and other health authorities. Maintain a constant state of inspection readiness and act as the senior leader and primary spokesperson during regulatory inspections and audits of the PV system.
Team Leadership & Development
Lead, mentor, and develop a high-performing global team of drug safety professionals. Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement. Attract and retain top-tier talent to build organizational capabilities for the future.
Executive & Cross-Functional Collaboration
Serve as the company’s top drug safety expert, providing strategic counsel to the executive leadership team, Board of Directors, and other senior stakeholders. Collaborate effectively with cross-functional partners in Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, and Commercial to ensure a unified approach to patient safety.
Medical Safety & Benefit-Risk Assessment
Provide expert medical review and interpretation of safety data from clinical trials and post-marketing sources. Lead the continuous assessment of the benefit-risk profile for all products throughout their lifecycle, making strategic recommendations to senior management.
Financial & Resource Management
Develop and manage the annual budget for the Global Drug Safety department. Ensure optimal allocation of resources, including personnel, technology, and external vendors, to meet strategic objectives and operational demands.
Requirements for the EVP, Global Drug Safety with a Biopharma Firm – Cambridge, MA
We are seeking a distinguished and accomplished leader with a proven track record of success in global drug safety. The ideal candidate will possess the following qualifications:
Educational Background
A Medical Degree (MD) or equivalent (e.g., DO) is required. Board certification in a relevant medical specialty is highly preferred.
Professional Experience
A minimum of 15-20 years of progressive experience in pharmacovigilance and drug safety within the pharmaceutical or biotechnology industry. At least 10 years of this experience must be in a senior leadership capacity, with demonstrated success in managing and scaling a global drug safety function.
Regulatory Expertise
Deep and current knowledge of global pharmacovigilance regulations, guidelines, and industry best practices (e.g., FDA, EMA GVP, ICH). Extensive, hands-on experience leading interactions with global health authorities on safety matters is essential.
Leadership & Management Skills
Proven ability to lead, influence, and motivate a large, geographically dispersed organization. A track record of building high-performing teams, mentoring future leaders, and driving a positive and compliant organizational culture.
Strategic Acumen
Exceptional strategic thinking and problem-solving skills. The ability to anticipate future trends in drug safety and regulation, and to translate strategic vision into actionable plans and tangible results.
Communication & Interpersonal Skills
Impeccable written and verbal communication skills. The ability to articulate complex scientific and medical concepts clearly and persuasively to a variety of audiences, from scientific experts to executive leadership and regulatory bodies. Strong influencing and negotiation skills are critical.
Technical Proficiency
Extensive experience with the entire drug development lifecycle, from early-stage clinical trials through post-marketing surveillance. Familiarity with standard safety databases (e.g., Argus, ARISg) and other PV-related technologies.
Personal Attributes
Unquestionable integrity, a strong sense of ethics, and a deep commitment to patient safety. A collaborative and decisive leadership style, with the ability to thrive in a fast-paced, dynamic, and innovative environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top executive talent by offering a highly competitive and comprehensive compensation and benefits package, including:
Executive Compensation
A highly competitive base salary and an attractive annual performance-based bonus.
Long-Term Incentives
A significant equity package (stock options and/or RSUs) to ensure a stake in the company’s long-term success.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your eligible dependents. A robust employee wellness program and other health-focused benefits.
Retirement Savings
A competitive 401(k) plan with a generous company match.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and company holidays.
Relocation Support
A comprehensive relocation package is available for the successful candidate and their family.
Professional Development
A dedicated budget for continued learning, executive coaching, and attendance at key industry conferences.
Location
The opportunity to work in the heart of Cambridge, MA, the world’s leading hub for biotechnology and pharmaceutical innovation.
How to Apply
This executive search is being conducted exclusively by JRG Partners. To be considered for this confidential opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role. We encourage you to explore our work and learn more about our dedicated team by visiting the JRG Partners’ Life Sciences executive search practice page. All inquiries and applications will be handled with the utmost discretion. JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees.
