Associate Director Regional Clinical Operations

• Accountable for oversight of all assigned studies within the country
• Accountable for planning and executing assigned country study goals and commitments
• Develops, builds and maintains optimal relationships with key institutions within the country
• Drive the identification and inclusion of sites that have access to and can enroll patients from underrepresented groups
• Oversees regional study feasibility, site monitoring performance, quality metrics
• Provides support and training for sites to support diverse recruitment and retention
• Conduct co-monitoring and site identification visits
• Collaborates cross-functionally to build and maintain strong relationships
• Communicates regularly on country study status and escalates unresolved issues
• Collaborates with the Global Study Team to develop and execute risk management plans
• Works with the Study Start-Up Team to ensure timely submission of regulatory documents
• Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections
• Ensures that clinical data from sites are of quality and delivered on time
• Represents country and line reports and provides actionable country-specific feedback
• Works closely with counterparts to share best practices and improve processes
• Ensures that the Incyte Clinical Trial Management and tracking systems are complete and up to date
• Proactively incorporate learning and recommendation from study debriefs
• Maintains oversight and ensures consistency across studies and alignment across CROs
• Makes an active contribution to therapeutic area strategy teams
• Manages issues related to local invoices and provide oversight of budget reconciliation
• Review CRO monitoring plans, training plans and relevant study plans

• Minimum Bachelor’s degree
• 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent
• At least 3 years in a role of primary responsibility for clinical trial execution and management
• Thorough understanding and experience in global clinical trials in a diverse range of patient populations
• Preferred experience in both oncology and hematology
• Direct management experience and supervisory responsibility
• Demonstrated leadership and management skills
• Goal oriented, self-starter with proven ability to work independently
• Good knowledge and experience working with external specialist vendors
• Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills
• Able to proactively identify issues and provide potential solutions
• Ability to manage multiple tasks simultaneously and meet deliverables
• Proficient in Outlook/Word/Excel/PowerPoint
• Must be able to travel (domestic and international) up to 20%

Experience in both oncology and hematology

• Competitive salary
• Various annual leave entitlements
• Range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme, LifeWorks
• Life assurance
• Flexible country-specific optional benefits