Clinical Operations Director for Global Trials in Mexico
hace 2 días
At Summittherapeutics, we are seeking a seasoned Clinical Operations Director to lead our team in Mexico.
About the RoleThis is an exceptional opportunity to join our organization as a key member of our Global Clinical Operations team. As a Clinical Operations Director, you will be accountable for providing leadership and operational expertise to execute phase 1-3 clinical trials in Mexico.
The role involves collaborating with Contract Research Organizations (CROs) to identify improvements in the operating model, building resource needs to support clinical trial delivery strategy, maintaining high visibility of operational topics among leadership and stakeholders, and leading the direction & strategy for a potential insourced clinical trial model for Mexico.
Key Responsibilities- Lead and manage operational excellence in Mexico through CRO delivery and future internalization of GCO's operating model where appropriate.
- Ensure operational deliverables in Mexico meet 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.
- Support the creation and direct a Mexico regional strategy including resource requirements and capabilities needed in accordance with global strategy and pace.
- Build strong relationships with Study Leads and Cross-Functional Teams to guide operational direction based on disease area expertise and country-specific needs.
- Feasibility:
- Understand and highlight country-specific strengths and opportunities in the strategy for selection of countries/sites for Mexico.
- Ensure timely inclusion of robust regional/country-level insights and feasibility outcomes into operational plans to enable effective delivery.
- In partnership with the global study team, maintain Mexico risks, proactively communicate progress, issues, or changes that may impact timelines and costs, and support mitigation of Mexico-specific systemic issues and risks.
- Accountable for study-level quality, 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, including GCO roles in study management, site engagement, and/or other local staff in Mexico.
We offer a competitive salary of $180,000 per annum, plus benefits and a bonus structure.
The ideal candidate will have a BA/BS degree in a scientific/medical field, advanced degree preferred, and a minimum of 10+ years of industry or related experience, with extensive early/late-stage drug development oncology experience, ideally including time in a Local or Global Study Leader role.
Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global environment is essential.
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