Clinical Operations Leader

“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 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 Head of Development Operations, the Clinical Operations Leader (COL) will be responsible for providing strategic leadership to ensure the successful operational execution of clinical trials in their assigned portfolio at the Gates MRI. The successful candidate will be an experienced hands-on leader that will serve as a functional lead and a subject matter clinical operations expert for the Gates MRI Development Operations team.

The COL will be responsible for ensuring that operational plans are developed to execute clinical studies and deliver quality data through all clinical trial phases across all programs in their assigned portfolio in accordance with the protocol, in compliance with ethical and regulatory requirements and in accordance with company SOPs, GCP and ICH guidelines within timelines and on budget.

The COL will ensure effective sponsor oversight of outsourced clinical operations activities performed through Gates MRI strategic partners and Functional Service Providers (FSPs). In addition, as a member of the Development Operations Leadership Team the COL will work collaboratively with other senior leaders within the Gates MRI organization to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.

KEY RESPONSIBILITIES INCLUDE:

Trial Oversight

• Accountable for sponsor oversight of outsourced clinical operations activities and ensuring vendor performance meets defined quality, timeline, budget, and performance expectations for studies within their portfolio.

• Implements a strong quality culture within Development Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices

• Participates in FSP governance activities and escalates operational risks, resource constraints, and performance issues as required.

• Accountable for ensuring clinical trials are ready for inspection, including appropriate sponsor oversight documentation.

• Provides strategic and tactical guidance in risk management and anticipate/recognize risks and issues on assigned programs and associated studies; manage resolution and/or escalation of study related issues.

• Champions opportunities to support capacitation of resources in LMIC.

Functional Management

• Serve as the primary operational interface with strategic partners and FSPs for their function, driving performance against KPIs/KRIs and participating in governance and escalation forums.

• Influence and guide strategic partner and FSP team members without direct authority, navigating matrix structures and governance to drive accountability and results.

Financial Oversight

• Drives the four-year planning process for their assigned programs in collaboration with Clinical Development Leaders.

• Ensures routine budget reviews for assigned programs are conducted to support the ongoing financial management process within the organization.

Program Strategy

• As a member of the Clinical Development Team, contributes to the operational strategy and tactics in the Clinical Development Plan for assigned programs.

Process

• Leads initiatives to build clinical department infrastructure and to improve efficiency and effectiveness of processes and procedures.

• Contributes to development of SOPs.

QUALIFICATIONS
The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics:

• 15+ years experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO, with at least 5+ years of people management

• Minimum B.A./B.S. degree in science/healthcare field or a nursing degree

• Demonstrated strong people management, coaching and mentoring skills

• Must have proven experience in CRO oversight, vendor selection, contract negotiation, and budget management

• Demonstrated experience operating within an outsourced/FSP delivery model and managing sponsor oversight responsibilities.

• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations

• Pre-clinical to Ph III experience with a particular focus on Phase III (large scale global clinical trials)

• Global experience working with developing countries and target populations – Africa, South East Asia, a plus

• Experience working with Infectious Diseases or Vaccines experience a plus

• Clear and effective communication & diplomacy skills

• Excellent leadership and interpersonal skills; ability to collaborate across disciplines with demonstrated ability to effectively lead multi-disciplinary global teams

• ‘Start up’ mentality with an ability to multitask across a wide range of responsibilities

• Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission.

• Local and international Travel ~20%

The target salary range for this role is $210,600 USD to $326,520 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 $234,600 USD to $362,800 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.

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

We’re committed to providing an inclusive and accessible hiring experience for all candidates. If you have a disability or medical condition and need an accommodation at any stage of the application or interview process—such as an ASL interpreter, alternative interview format, or physical accessibility support—we’re happy to help. Please contact View email address on aiapply.co with the position number and a brief description of your accommodation needs. Requests will be handled confidentially.

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.