Director, Clinical Operations

**Overview of Role**:
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 engagement
- Strategize local needs and help build resource needs to support the clinical trial delivery strategy in an effective, efficient, and compliant manner
- Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders
- Lead and inform the direction & strategy for a potential insourced clinical trial model for the Mexico in alignment with global strategy

**Role 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 commitments
- Function as a key point of escalation for issues and problem resolution impacting new and ongoing studies to ensure business critical milestones are achieved for Mexico
- In accordance with the global strategy and pace, support the creation and direct on a Mexico regional strategy including resource requirements and capabilities needed
- Build 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 Mexico
- Ensures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to plan
- In 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 readiness
- Line management of regional team in line with business needs. This may include but not limited to GCO roles in the following areas - study management, site engagement, and/or other local staff working from the Mexico region.
- All other duties as assigned

**Experience, Education and Specialized Knowledge and Skills**:

- BA/BS required; in a scientific/medical field preferred. Advanced degree preferred.
- A minimum of 10+ years industry or related experience
- Extensive early/late-stage drug development oncology experience ideally including time in role such as a Local or Global Study Leader
- Knowledge and experience of drug development in Mexico region
- Proven line and performance management experience; functional management experience, managing resourcing and budget planning and oversight.
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
- Proven organization design and change management experience
- Excellent written and verbal communication skills
- Proven ability to develop successful collaborations with internal and external partners