Associate Director, Regional Clinical Study Management

Accountabilities:

• • Lead the planning, implementation, and conduct of large, global, and complex oncology clinical trials across Phases I–IV, or multiple smaller early-phase studies.
  • Oversee regional clinical study activities with a high degree of autonomy, ensuring operational plans, milestones, timelines, and deliverables are clearly defined and achieved.
  • Support the development of the clinical operations team in Brazil, including hiring, training, resource allocation, mentoring, and oversight of external FSP resources.
  • Act as the primary clinical operations point of contact for protocol execution, coordinating study teams and ensuring effective delivery across sites and partners.
  • Manage CROs, vendors, consultants, investigators, and other external stakeholders, including vendor selection, performance management, issue resolution, and governance.
  • Establish and monitor study milestones, metrics, timelines, risks, and escalation processes, ensuring management has accurate and timely visibility into study performance.
  • Ensure clinical trials comply with ICH/GCP requirements, applicable federal and local regulations, internal SOPs, and quality standards.
  • Review and provide input into clinical documentation, including protocols, informed consent materials, Investigator Brochures, regulatory updates, monitoring reports, and other study-related documents.
  • Oversee monitoring activities, review clinical monitoring reports, and ensure outstanding findings and follow-up actions are resolved promptly.
  • Maintain oversight of Trial Master File activities, conducting periodic reviews to ensure completeness, accuracy, and compliance throughout the study lifecycle.
  • Support regulatory submissions and participate in Quality Assurance and regulatory authority inspections, including preparation and response activities.
  • Ensure clinical data quality and integrity across assigned studies and participate in relevant governance committees and cross-functional program forums.
  • Partner with clinical supply teams to ensure accurate forecasting and availability of clinical and non-clinical supplies according to protocol requirements.
  • Manage clinical trial and program-level budgets, including site budgets, vendor payments, change orders, financial projections, and reporting in collaboration with Finance and Legal teams.
  • Support CRO bid defenses and vendor selection activities, including scope-of-work development, budget assessment, and performance evaluation.
  • Provide cross-functional leadership to ensure clinical program timelines and objectives are achieved.
  • Mentor junior clinical operations professionals and contribute to team development, performance management, training, SOP development, and operational improvement initiatives.

  Requirements:

  • Bachelor’s degree or higher in a scientific, healthcare, or related discipline; a Master’s degree is preferred.
  • 10+ years of experience in clinical research, with at least 5 years of experience in clinical project management and/or clinical monitoring preferred.
  • Strong experience managing clinical trials, ideally within the pharmaceutical, biotechnology, or oncology sector.
  • Demonstrated knowledge and practical application of current FDA regulations, ICH/GCP guidelines, and applicable clinical research requirements.
  • Experience developing trial plans covering areas such as site monitoring, pharmacy and laboratory manuals, risk mitigation, budgets, site selection, and feasibility.
  • Experience managing CROs, vendors, consultants, and external clinical research partners.
  • Prior participation in regulatory authority inspections is strongly preferred.
  • Strong clinical operations, project management, organizational, and leadership capabilities.
  • Excellent written and verbal communication skills, with the ability to communicate effectively with study teams, investigators, sites, cross-functional stakeholders, and external partners.
  • Strong negotiation and collaboration skills, with the ability to manage competing priorities and resolve complex operational issues.
  • Therapeutic or medical knowledge, particularly in oncology, is preferred.
  • Experience managing and mentoring direct or indirect reports, including performance discussions, development planning, delegation, and constructive feedback.
  • Strong proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and MS Project.
  • Fluent English is required.
  • Ability to travel approximately 10–25% as required by clinical operations and study activities.

  Benefits:

  • Hybrid work model based in São Paulo, Brazil.
  • Opportunity to lead regional clinical operations for complex oncology studies across Phase I–IV development programs.
  • Senior-level exposure to global clinical development, regulatory, and cross-functional teams.
  • Professional growth through leadership responsibilities, mentoring, and operational improvement initiatives.
  • Opportunity to work with multidisciplinary internal teams, CROs, investigators, vendors, and external clinical partners.
  • Exposure to high-impact clinical research programs and complex international study environments.
  • Travel opportunities of approximately 10–25% in support of regional clinical activities.
  • The original job posting does not specify salary, healthcare coverage, bonus structure, or additional benefits; these details should be confirmed during the hiring process.