Position Summary

***This position is open to any qualified candidate who is currently located in Spain or is willing to relocate to the region***

The Regional Director, Clinical Operations will provide strategic and operational leadership for all clinical site management activities including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Odonate’s clinical studies within their designated region in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. The Regional Director, Clinical Operations will be responsible for direct management of Site Directors and Site Managers employed by Odonate or contracted through a Contract Research Organization (CRO) or another resourcing entity. This position will oversee activities of Site Directors and Site Managers in their region to ensure that patients’ rights, safety and well-being are protected and that the data generated at sites are complete and accurate. Together with Site Directors, Clinical Operations will be accountable for patient enrollment and delivery of high-quality patient data in established timelines for all sites within their region. 

Essential Duties and Responsibilities

  • Accountable for overall Clinical Operations activities within the respective region
  • Manage and oversee activities of Site Directors and Site Managers to ensure the successful start-up, monitoring and execution of Phase I-IV trials in respective region
  • Generate resource allocation plans including Site Directors and Site Managers personnel requirements for designated region
  • Onboard, train, coach and mentor Site Directors and Site Managers assigned to designated region
  • Ensure team member completion of GCP and internal training in a timely manner
  • Develop performance measures and evaluate Site Director and Site Manager performance and quality of work via periodic co-monitoring visits and evaluation of performance measures
  • Directly responsible for agreed upon number of sites for clinical site management activities including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities and inspection readiness
  • Develop and cultivate strong site relationships and ensure continuity of site relationships
  • In conjunction with Site Directors and Site Managers, communicate with investigators and site staff on escalated issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
  • Oversee feasibility and site identification activities in designated region for new clinical studies; as appropriate, identify sites within the region for participation on clinical studies
  • Manage start-up and maintenance activities for designated region including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
  • Oversee communication with appropriate site staff involved in start-up and IRB/EC submissions in respective region
  • Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for sites in designated region in collaboration with clinical project management and finance
  • Develop site specific recruitment, retention and follow-up plans for respective region
  • Ensure that Site Director and Site Manager clinical site management and monitoring activities are performed in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
  • Oversee Site Director and Site Manager remote data review, query resolution and action plans
  • Review of monitoring visit reports for sites in designated region in accordance with clinical monitoring plan and relevant SOPs
  • Ensure follow up and close-out of all issues identified in monitoring visit reports for assigned region
  • Ensure sites within assigned region are inspection ready
  • Conduct risk assessment categorization activities with cross-functional study teams, including protocol and site-level risk assessments
  • Facilitate and support investigator site audits and/or inspection activities
  • Work with relevant team members to identify appropriate corrective actions to resolve site performance or quality issues in a timely manner and to follow through until completion
  • In conjunction with the Vice President of Clinical Operations, create and maintain study level clinical monitoring plans, study start up plan and feasibility form
  • Report and track pertinent study information and proactive communication of progress and issues to key stakeholders
  • Review, support and contribute to appropriate metrics related to clinical trial conduct
  • Serve as clinical operations lead for a region, a study and/or process or activity
  • Review clinical study documents, including study protocols and provide feedback as pertinent to clinical operations
  • Lead the review of Odonate’s systems and procedures as needed
  • Contribute to overall clinical operations team knowledge by sharing best practices and leading improvement initiatives
  • Execute other duties as required

Qualifications

  • Bachelor’s Degree in a Life Sciences discipline required
  • Master’s Degree, Bachelor’s Degree in Nursing or RN a plus
  • Minimum 5 years of clinical trial experience required
  • Minimum 3 years of professional experience in the oncology therapeutic area required
  • Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development required
  • Detailed understanding of FDA, EMA, ICH and GCP guidelines and applicable local regulations
  • Proven leadership abilities in a highly complex, dynamic and fast-paced environment
  • Ability to inspire a collaborative team environment
  • Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and oncology treatment landscapes
  • Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
  • Detail-oriented, organized and committed to quality and consistency
  • Results driven and capable of managing competing high-priority assignments
  • Proven track record of achieving deliverables within specified timelines
  • Excellent team-interaction skills and ability to work successfully in team settings
  • Ability to work in a dynamic environment with a high degree of flexibility
  • Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs
  • Excellent written and verbal communication skills in English, as well as in applicable local language
  • Ability to communicate effectively with Key Opinion Leaders, site staff, internal team members and Odonate Senior Leadership
  • Experience and proven proficiency in CTMS and eTMF systems preferred
  • Ability to travel up to 30-50% domestic and/or international required

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