Head of Pharmacovigilance and Drug Safety

“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”

 -Bill Gates

The Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute.  Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration.  The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions.  The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.

The Institute is based on five core “mantras” that are embedded within the organization and its people:

• Urgency: Execute with excellence to maximize impact.

• Collaboration: Establish empowered teams to drive our bottom line: lives saved.
• Innovation: Build on the known, uncover the new, achieve the unprecedented.
• Rigor: Drive the science, focus on the details, and execute with the highest quality.
• Courage: Dare to confront the world’s most significant global health challenges.

Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.

As a wholly owned subsidiary and separate legal entity of the Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.

The Institute leverages dedicated vendor partnerships and consultant staff to ensure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.

The Institute offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package for those looking to move to the Cambridge, MA area.  Remote arrangements may be available for this role subject to all legal and logistical requirements that may vary by remote location.

THE POSITION

Reporting to the Chief Medical Officer, the Head of Pharmacovigilance and Drug Safety serves as the enterprise safety strategy owner, responsible for designing, governing, and optimizing an end‑to‑end global pharmacovigilance system. This role provides strategic leadership for all Gates MRI clinical programs by overseeing enterprise safety governance, safety risk management, safety data integration across partners, medical oversight of case processing, cross portfolio signal detection and benefit - risk evaluation in collaboration with the PV Operations Functional Service Provider (FSP).  It will liaise with commercialization partners to guide risk management plan development and post-market approval safety surveillance systems and processes for Gates MRI assets.

This role will oversee patient/participant safety in collaboration with clinical development leaders across programs including contributions to relevant clinical trial design elements, and ensure the timeliness and integrity of safety reporting for the portfolio of clinical trials that are conducted by Gates MRI in diverse environments, from experimental medicine and controlled human infection trials to large, multinational Phase 2b and Phase 3 prevention and treatment trials in low- and middle-income settings

The successful candidate will be an experienced hands-on leader that will serve as a medical lead and a drug safety subject matter and pharmacovigilance process expert. They will be responsible for ensuring that safety oversight for clinical trials in all phases is conducted in accordance with the protocol, in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP, and ICH guidelines and partner requirements.

The Gates MRI works in an outsourced model.  To evolve and maintain our PV and DS strategy, this role will partner closely with our designated FSP primarily, leveraging other resource models in times of demonstrable need.  It will also maintain development and compliance accountability supported in execution by our FSP partner on a day-to-day basis.

In addition, the person will work collaboratively with other leaders within the Gates MRI organization to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.

This role will oversee the development and execution of safety data exchange agreements with each partner and act as the medical safety lead in ongoing collaborations to ensure optimal relationship management. From a vendor management perspective, it will have oversight of the performance and compliance of medical safety activities performed by vendors, including medical review of individual case safety reports, in collaboration with the MRI clinicians.

This position will aid the CMO and the Head of Development Operations to ensure rigorous and robust processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities are in place and operating optimally. It will have oversight of the performance and compliance of medical safety activities performed by vendors, including medical review of individual case safety reports, in collaboration with the MRI clinical development leaders.

Responsibilities

• Oversee the Safety Review Committee process, which has primary responsibility for assessing emerging safety signals from ongoing clinical trials and provide input into safety data monitoring plans.
• Provide pharmacovigilance input for trial protocols, safety monitoring plans and other clinical study-relevant documents, review safety tables, figures, and listings from clinical trials, and author/supervise the preparation of safety update reports and safety contents for regulatory filings including new drug applications and marketing authorization applications.

• Own the global safety strategy and governance framework for all Gates MRI programs, ensuring integrated, risk-based PV oversight across internal teams, FSP partners, external partners, and CROs, as applicable.
• Oversee and direct medical review of all safety cases across programs, including MD adjudication of validity, completeness, causality, expectedness, and regulatory classification, delegating operational execution to FSP teams while maintaining final medical accountability.
• Oversee the development of all safety regulatory deliverables—including DSURs, safety narratives, Module 2.5/2.7.4 components of global submissions, SAHPRA periodic reports, and safety contributions to NDA/MAA filings—ensuring alignment across partners, FSP, and internal development leads.
• Direct cross portfolio safety surveillance, including daily SAE review (via FSP), signal detection algorithms, monthly PV review, quarterly Safety Review Committee (SRC), biannual ESC, and alignment with IDMC/SRT processes.
• Provide pharmacovigilance medical support for the Clinical Development portfolio.
• Provide medical review of clinical ICSRs and clinical study coding.
• Collaborate with cross functional team on regulatory submission of safety documents such as DSURs, 6 monthly SAHPRA reports, and other required aggregate study reports to support regulatory compliance in the study regions.
• Provide company approval for external safety reporting to health authorities, investigators, and partners as required.
• Collaborate with global partnerships (academic, nonprofit, large pharma, and biotech companies) in complex combination product development. Design and oversee complex multi partner safety data exchange models and governance structures, including authoring safety data exchange agreements (SDEAs), ensuring compliant bilateral/multilateral data flow across compound providers, CROs, clinical networks, and regulatory partners.
• Contribute to study protocols, investigator brochures, safety management and expedited reporting plans, clinical study reports with associated tables, listings and figures, and other study related documents from a clinical safety perspective.
• Serve as the strategic safety architect in clinical development, providing forward looking PV input into clinical trial design, protocol risk mitigation strategies, composite endpoints involving safety, unblinding needs, operational feasibility in LMIC settings, and adaptive trial safety oversight models.
• Support Safety Governance and signal detection, contributing to scheduled and ad hoc SRC/ESC meetings by reviewing and synthesizing clinical safety data with study team for committee members.
• Liaise with commercialization partners to provide strategic input on post-market approval safety surveillance systems and processes for Gates MRI assets.

Qualifications

The successful candidate will be an innovative and highly creative individual who thrives in a matrixed,” get it done” type of environment with a strong track record of hands-on experience in translational medicine. (S)he will have the following mix of personal and professional characteristics

• Medical degree (MD/DO) required, with clinical medical experience preferred
• 10+ years in pharmacovigilance, drug safety and clinical development leadership with demonstrated experience building or transforming enterprise PV systems and delivering safety governance across multinational clinical programs.
• Proven ability to lead through influence across decentralized delivery models, including FSP oversight, vendor governance, and cross organizational scientific alignment.
• Pre-clinical, Phase I to Ph III development experience with a particular focus on Phase III (large scale global clinical trials) required
• Extensive experience operating within complex global partnerships, including academia, non‑profits, large pharma’s, biotech partners, CRO networks, and LMIC clinical trial ecosystems, with a strong background in infectious disease and vaccine development.
• Detailed knowledge of GCP, ICH Guidelines and US FDA regulations
• Excellent leadership and interpersonal skills with the right balance of empathy and assertiveness; ability to collaborate across disciplines and influence others at all levels and lead in a highly matrixed organization.
• Clear and effective communication & diplomacy skills
• Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission
• Trustworthy with highest integrity, committed to ethics and scientific standards
• Outstanding communication skills; ability to work well with a wide range of internal and external stakeholders and build strong partnerships and alliances inside and outside the organization.
• Experience building capability, both internally within own organization and externally with a range of partners is desired.

The target salary range for this role is $425,000 USD to $440,000 USD. We recognize high-wage market differences in Seattle, WA and Cambridge, MA, where our offices are located. The range for this role in these locations is $440,000 to $510,000 USD. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

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Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Candidate Accommodations

If you require assistance due to a disability in the application or recruitment process, please submit a request here.

Inclusion Statement

We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.