Summittherapeutics | Director, Clinical Operations

hace 2 días

distrito federal, México Summittherapeutics A tiempo completo
Job Title: Director, Clinical Operations (Mexico) Department: Clinical Operations Location: Remote Mexico

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 Mexico in alignment with global strategy.

Role and Responsibilities:

  • Accountable to lead, manage and drive operational excellence in Mexico 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.
  • 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 Summit Study Leads and Study 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.
  • 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 of 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 the 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.
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