Clinical Development Consultant
Eli Lilly and Company
Total years of experience :9 years, 8 Months
Business Development and Customer Management
• Led feasibility assessment of global clinical trials (Phase I~III) for oncology and diabetes
• Developed and managed relationships with the principal investigators and research centers
Operation and Project Management
• Took crucial role in global clinical trials for new drug development, including site selection, activation, and management to meet key milestones, having completed or managed more than 20 trial projects on time
• Led projects as a liaison among global study teams, medical advisors, CROs, investigators, and so on.
• Achieved the fastest and highest patient enrolment rate with greater than 700% and 200% for diabetes and oncology trials respectively by reducing overall process schedule and collaborating with investigators
• Spearheaded APAC as a Lead Subject Matter Expert (SME) for clinical trial management system and site selection
• Led cross-functional teams around the globe as a study manager of post-marketing surveillance(PMS) studies in Korea and the Philippines, controlling overall projects, budgets, and CROs of research projects to reach milestone within timeline without major issues
• Led successful negotiation with Korean regulatory authority to adjust required number of patients from 3, 000 to 1, 200 and transition with Takeda and BMS for PMS studies
Medical Information Service
• Organized scientific communication and medical marketing activity with medical professionals through collaboration with medical, sales, and marketing team
Pharmacovigilance
• Supervised drug safety system through close interaction with R&D center in Denmark and regulatory authority to monitor adverse events of marketed drugs
Sales Representative Training
• Controlled training for sales representatives to have up-to-date medical information, and adapted customized distant training system for cost-effective training
Led team at police checkpoint and situation room