Clinical Operations Leader

Gates Foundation•Cambridge, MA

1d•Hybrid

About The Position

The Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization focused on developing impactful biopharmaceutical interventions for diseases affecting the world's poorest populations. Headquartered in Cambridge, MA, the Institute aims to advance novel drug, biologics, and vaccine candidates through late-stage development and registration. It comprises experienced professionals in regulatory, CMC, and clinical functions, along with operational support. The Institute operates on five core values: Urgency, Collaboration, Innovation, Rigor, and Courage. As a subsidiary of the Gates Foundation, Gates MRI partners with the foundation to achieve global health equity. The Institute offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package. Remote arrangements may be available for this role, subject to legal and logistical requirements. Reporting to the Head of Development Operations, the Clinical Operations Leader (COL) will provide strategic leadership for the operational execution of clinical trials within their assigned portfolio at Gates MRI. This role requires an experienced, hands-on leader who will serve as a functional lead and subject matter expert for the Development Operations team. The COL will be responsible for developing operational plans to execute clinical studies, ensuring the delivery of quality data across all trial phases and programs in their portfolio, in compliance with protocols, ethical and regulatory requirements, company SOPs, GCP, and ICH guidelines, all within timelines and budget. The COL will also ensure effective sponsor oversight of outsourced clinical operations activities performed by Gates MRI's strategic partners and Functional Service Providers (FSPs). As a member of the Development Operations Leadership Team, the COL will collaborate with other senior leaders to enhance the effectiveness and efficiency of clinical trial support processes and procedures.

Requirements

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.

Nice To Haves

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

Responsibilities

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 anticipates/recognizes risks and issues on assigned programs and associated studies; manages resolution and/or escalation of study related issues.
Champions opportunities to support capacitation of resources in LMIC.
Serves 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.
Influences and guides strategic partner and FSP team members without direct authority, navigating matrix structures and governance to drive accountability and results.
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.
As a member of the Clinical Development Team, contributes to the operational strategy and tactics in the Clinical Development Plan for assigned programs.
Leads initiatives to build clinical department infrastructure and to improve efficiency and effectiveness of processes and procedures.
Contributes to development of SOPs.