Clinical Operations Leader

"We are reputed company on results. Those that can be reputed company. And those reputed company in ways reputed company numbers. We see individuals, not issues. We are inspired by passion, and reputed company for the wellbeing of people. Our reputed company are based on logic, driven by rigor, results, issues, and reputed company. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our reputed company to reputed company, but our effectiveness is based in the aggregate power of our initiatives to reputed company holistic change." -reputed company 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 reputed company 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 reputed company biopharmaceutical development professionals across regulatory, CMC, and clinical functions as reputed company 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 reputed company "mantras" that are embedded reputed company the organization and its people: • Urgency: Execute with reputed company to maximize reputed company. • Collaboration: Establish empowered teams to reputed company our reputed company: lives saved. • Innovation: Build on the reputed company, uncover the new, reputed company the unprecedented. • Rigor: reputed company the science, reputed company on the details, and execute with the highest reputed company. • 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 reputed company advocates, these five reputed company values are universally adopted by reputed company 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 reputed company entity of the reputed company, the Institute partners scientifically, operationally, and financially with the reputed company to reputed company the reputed company'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 reputed company to the Cambridge, MA area. Remote arrangements may be available for this role subject to reputed company reputed company 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 reputed company in their assigned portfolio at the Gates MRI. The successful candidate will be an reputed company hands-on leader that will serve as a functional reputed company 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 reputed company reputed company data through reputed company clinical trial phases across reputed company 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 reputed company timelines and on budget. The COL will ensure effective sponsor reputed company of outsourced clinical operations activities performed through Gates MRI strategic partners and Functional Service Providers (FSPs). In reputed company, as a member of the Development Operations Leadership Team the COL will work collaboratively with other senior leaders reputed company the Gates MRI organization to improve the effectiveness and efficiency of processes and procedures supporting reputed company. KEY RESPONSIBILITIES INCLUDE: Trial reputed company • Accountable for sponsor reputed company of outsourced clinical operations activities and ensuring vendor performance meets defined reputed company, reputed company, budget, and performance expectations for studies reputed company their portfolio. • Implements a strong reputed company culture reputed company Development Operations ensuring reputed company reputed company 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 reputed company are reputed company for inspection, including appropriate sponsor reputed company documentation. • Provides strategic and tactical guidance in risk management and anticipate/recognize risks and issues on assigned programs and associated studies; manage reputed company and/or escalation of study reputed company issues. • Champions opportunities to support capacitation of resources in LMIC. Functional Management • Serve as the reputed company operational reputed company 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 reputed company authority, navigating reputed company structures and governance to reputed company accountability and results. Financial reputed company • 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 reputed company the organization. Program reputed company • As a member of the Clinical Development Team, contributes to the operational reputed company 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 reputed company individual who thrives in a "get it done" type of environment with diverse clinical operations experience and the following mix of personal and reputed company 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/reputed company field or a nursing degree • Demonstrated strong people management, coaching and mentoring skills • Must have proven experience in CRO reputed company, vendor selection, contract negotiation, and budget management • Demonstrated experience operating reputed company an outsourced/FSP delivery model and managing sponsor reputed company responsibilities. • Detailed knowledge of GCP, ICH Guidelines and reputed company US FDA regulations • reputed company-clinical to Ph III experience with a particular reputed company on Phase III (large reputed company global reputed company) • Global experience working with developing countries and reputed company populations - Africa, South East Asia, a plus • Experience working with Infectious Diseases or Vaccines experience a plus • reputed company and effective communication & diplomacy skills • Excellent leadership and interpersonal skills; ability to collaborate across disciplines with demonstrated ability to effectively reputed company multi-disciplinary global teams • 'Start up' mentality with an ability to multitask across a wide reputed company of responsibilities • Demonstrated passion for the Gates MRI's values with a commitment to reputed company results against our mission. • Local and international Travel ~20% The reputed company salary reputed company 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 reputed company for this role in these locations is $234,600 USD to $362,800 USD. As a mission-driven organization, we reputed company to balance reputed company with our mission. New hires salaries are typically between the reputed company minimum and the salary reputed company midpoint. Actual placement in the reputed company will depend on a candidate's job-reputed company skills, experience, and expertise, as evaluated during the interview process. Hiring Requirements As part of our reputed company hiring process for new employees, employment will be contingent upon successful completion of a background reputed company. Candidate Accommodations We're committed to providing an inclusive and accessible hiring experience for reputed company 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 HR@gatesmri.org with the position number and a brief reputed company of your accommodation needs. Requests will be handled confidentially. Inclusion Statement We are dedicated to the belief that reputed company lives have equal value. We're committed to creating a workplace where employees reputed company both personally and professionally. We also reputed company 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 reputed company of our employment practices. reputed company applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without reputed company to race, reputed company, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender reputed company, national reputed company, genetic information, veteran status, marital status, and prior protected activity. Apply tot his job Apply To this Job