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.