.Career Opportunities with Summit Therapeutics Sub, Inc.A great place to work.Careers At Summit Therapeutics Sub, Inc.Current job opportunities are posted here as they become available.The Director, Clinical Operations Mexico, is accountable for providing leadership and operational expertise into execution of one or more phase 1-3 clinical trials conducted in Mexico.
The role will be part of the Global Clinical Operations (GCO) group reporting into USA VP, Head of Clinical Operations.
This position is expected to:Collaborate with Contract Research Organization (CROs) and identify, champion, and implement key improvements in the outsourced operating model for optimization, performance, and site engagementStrategize local needs and help build resource needs to support the clinical trial delivery strategy in an effective, efficient, and compliant mannerResponsible for maintaining high level of visibility of operational topics among leadership and stakeholdersLead and inform the direction & strategy for a potential insourced clinical trial model for the Mexico in alignment with global strategyRole and Responsibilities:Accountable to lead, manage and drive operational excellence in Mexico.
This will be accomplished through CRO delivery and considerations of future internalization of GCO's operating model where appropriate.Responsible for operational deliverables in Mexico in accordance with time, cost, and quality commitmentsFunction as a key point of escalation for issues and problem resolution impacting new and ongoing studies to ensure business critical milestones are achieved for MexicoIn accordance with the global strategy and pace, support the creation and direct on a Mexico regional strategy including resource requirements and capabilities neededBuild strong relationships with Summit Study Leads and Study Cross-Functional Teams.
They will leverage this information to help guide in operational direction of disease area expertise and country specific expertise specific to Mexico needs.Feasibility:Understands and highlights country specific strength and opportunities in the creation of the strategy for selection of countries/sites for MexicoEnsures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to planIn partnership with the global study team, maintains Mexico risks, proactively communicates progress, issues or changes that may impact timelines and costs.
Identifies trends & patterns across study and program level and supports mitigation and prevention of Mexico specific systemic issues and risks.Accountable for the study level quality, and compliance with GCP, local laws and regulations and guide the team with local HA inspection readinessLine management of regional team in line with business needs