Role Overview for EVP, Head of Global Medical Safety with a Biopharma Firm – Cambridge, MA
JRG Partners is proud to partner with a pioneering, research-driven biopharmaceutical company in Cambridge, MA, dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are seeking a visionary and strategic leader to join their executive team as the Executive Vice President (EVP), Head of Global Medical Safety. This is a paramount role responsible for shaping the future of patient safety and pharmacovigilance across the company’s entire portfolio, from early development through post-market lifecycle management.
The EVP, Head of Global Medical Safety will be the ultimate authority on all matters related to drug safety, providing strategic direction and operational oversight for the global pharmacovigilance and risk management functions. This individual will ensure that the company upholds the highest standards of patient safety, regulatory compliance, and ethical conduct worldwide. Reporting directly to the Chief Medical Officer, this executive will be a key member of the senior leadership team, influencing corporate strategy and fostering a culture where patient safety is paramount. The ideal candidate will be a seasoned physician with extensive experience in the biopharmaceutical industry, possessing a deep understanding of global safety regulations, a proven track record of leading large, complex teams, and the executive presence to navigate a dynamic and scientifically-driven environment. This position offers a unique opportunity to make a significant impact on global health by ensuring the safety and well-being of patients who rely on our client’s life-changing therapies.
Key Responsibilities of EVP, Head of Global Medical Safety with a Biopharma Firm – Cambridge, MA
The EVP, Head of Global Medical Safety will have a broad and impactful remit, encompassing strategic leadership, operational excellence, and cross-functional collaboration. Key responsibilities include:
Strategic Leadership & Vision
- Develop and execute a comprehensive global medical safety and pharmacovigilance strategy that aligns with the company’s long-term corporate objectives and evolving regulatory landscape.
- Serve as the company’s foremost expert on drug safety, providing strategic counsel to the executive leadership team, Board of Directors, and other key stakeholders on all safety-related matters.
- Champion a proactive, science-driven approach to safety surveillance and risk management, integrating innovative technologies and methodologies to enhance signal detection and risk assessment.
- Anticipate and interpret changes in global pharmacovigilance regulations and guidelines, ensuring the organization is prepared to meet future compliance and safety challenges.
- Drive the continuous improvement and optimization of the global safety function, fostering a culture of excellence, accountability, and patient-centricity.
Pharmacovigilance Operations & Signal Detection
- Provide ultimate oversight for all global pharmacovigilance activities, including the collection, processing, and reporting of Individual Case Safety Reports (ICSRs) from all sources.
- Ensure the timely and high-quality preparation and submission of aggregate safety reports, such as PBRERs/PSURs, DSURs, and PADERs, to global health authorities.
- Lead the signal detection and management process, ensuring robust systems are in place for the ongoing review of safety data to identify, evaluate, and manage potential safety signals.
- Oversee the management and continuous enhancement of the global safety database (e.g., Argus, ArisG) to ensure data integrity, system validation, and operational efficiency.
- Direct the development and maintenance of all pharmacovigilance-related standard operating procedures (SOPs), work instructions, and training programs to ensure global consistency and compliance.
Risk Management & Mitigation
- Lead the development, implementation, and lifecycle management of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) for the company’s product portfolio.
- Chair the corporate Safety Management Team and other high-level governance committees responsible for making critical decisions on product safety issues and risk-benefit profiles.
- Provide expert medical analysis and interpretation of safety data from clinical trials and post-marketing sources to inform risk management strategies.
- Collaborate with clinical development, medical affairs, and regulatory affairs to ensure that safety and risk management considerations are integrated throughout the product lifecycle.
Regulatory Compliance & Inspections
- Serve as the primary point of contact for global health authorities (e.g., FDA, EMA, PMDA) on all significant pharmacovigilance and medical safety matters.
- Ensure the organization is perpetually prepared for regulatory inspections and audits, leading the development of responses to inspection findings and overseeing the implementation of corrective and preventive action plans (CAPAs).
- Maintain expert knowledge of international drug safety regulations, including ICH guidelines and specific requirements of major regulatory bodies, ensuring strict adherence to Good Pharmacovigilance Practices (GVP).
- Oversee the safety aspects of regulatory submissions, including NDAs, BLAs, and MAAs, ensuring all safety-related documentation is accurate, complete, and of the highest quality.
Team Leadership & Development
- Lead, mentor, and develop a large, global team of medical safety professionals, including physicians, scientists, and operations staff.
- Foster a collaborative, inclusive, and high-performing team culture that attracts, develops, and retains top talent in the pharmacovigilance field.
- Establish clear performance objectives, provide regular feedback, and support the professional growth and career development of all team members.
- Manage the departmental budget, resource allocation, and vendor/partner relationships to ensure the efficient and effective operation of the global safety function.
Requirements for the EVP, Head of Global Medical Safety with a Biopharma Firm – Cambridge, MA
Candidates must possess a unique blend of medical expertise, industry experience, and executive leadership capabilities. The following qualifications are essential for success in this role:
Educational & Professional Qualifications
Medical Doctor (MD) or equivalent (e.g., DO, MBBS) is required.
- Board certification in a relevant medical specialty is highly preferred.
- Advanced degrees such as a PhD, MPH, or MBA are advantageous.
Experience
- A minimum of 15-20 years of progressive experience in the biopharmaceutical industry, with at least 10 years in a senior leadership role within global pharmacovigilance, drug safety, or clinical development with a safety focus.
- Proven track record of successfully leading a global medical safety function, including managing teams across different regions and time zones.
- Extensive experience across the entire product lifecycle, from first-in-human studies to post-marketing surveillance and lifecycle management.
- Demonstrated experience as the primary company representative in interactions with major global health authorities, including direct involvement in regulatory inspections.
- Deep experience in both small molecules and biologics is highly desirable; experience in specific therapeutic areas such as oncology, immunology, or rare diseases is a plus.
Skills & Competencies
Executive Leadership
Exceptional strategic thinking, business acumen, and the ability to influence at all levels of the organization, including the C-suite and Board of Directors.
Regulatory Expertise
In-depth, expert knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.).
Scientific Acumen
Strong clinical and scientific background with the ability to critically evaluate and interpret complex safety data and make sound, data-driven decisions.
Communication
Outstanding written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely to diverse audiences.
Problem-Solving
Superior analytical and problem-solving skills, with a demonstrated ability to manage and resolve complex safety crises effectively.
Interpersonal Skills
Proven ability to build and maintain strong, collaborative relationships with internal and external stakeholders.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive executive compensation and benefits package, including:
Competitive Base Salary
An attractive base salary commensurate with executive-level experience and impact.
Annual Bonus
A significant performance-based annual bonus opportunity.
Long-Term Incentives
A substantial equity package (stock options/RSUs) to ensure alignment with the company’s long-term success.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your eligible dependents, along with wellness programs and resources.
Retirement Savings
A generous 401(k) plan with a competitive company match.
Paid Time Off
A flexible and generous paid time off policy, including vacation, sick leave, and company holidays.
Professional Development
A dedicated budget for continuing education, conference attendance, and professional memberships.
Relocation Assistance
A comprehensive relocation package is available for the successful candidate.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a transformative leader with the experience and passion to lead a world-class global medical safety organization, we invite you to apply.
To express your interest in this confidential opportunity, please submit your CV and a cover letter. For more information or to explore other opportunities within our portfolio, please visit the JRG Partners’ Life Sciences executive search practice page. Our client is an equal opportunity employer and values diversity at their company. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
