Harshani Hettiarachchi
Associate Director Clinical Delivery Program Lead @Eli Lilly and Company
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WORK HISTORY
Associate Director Clinical Delivery Program Lead @Eli Lilly and Company
Phase 1 program lead on strategic and operational input into trial design and execution oversight from Preclinical through to Phase 2, CRO and site selection, coaching and oversight of clinical trial program managers, Subject Matter Expert for implementing process and procedure quality systems in Site selection, ICFs. Lead for Ph1 early phase Operations for particular molecules and main point of contact for compound and trial level progress. Lead for vendor management, issue and risk, Biopharm submission coordination of phase 1 data into MAA or BLA.
EDUCATION
University of East London
MSc, Biomedical Science
University of Liverpool
Bachelor's degree, Human Biological Science and Environmental Management
ABOUT HARSHANI HETTIARACHCHI
Experienced Clinical Program Lead, with a 16-year demonstrated history of working in the clinical research industry. Skilled in Phase 1 to 4 clinical trial management, with predominant early phase experience, in Diabetes, Heart Failure, Advanced Therapy Medicinal Products (Gene and Cell Therapy). Extensive experience of end to end drug development from Preclinical / concept design through to study start and submission of NDA/ MAA. Deep experience of ICH GCP, FDA, UK and EU Regulations, Clinical Monitoring. Skilled in vendor, issue, risk, and overall project and Program management of phase 1 clinical trials. Strong knowledge of clinical trial processes, requirements and regulations in Clinical trial start up to close out, regulatory reporting and process improvements. Experienced coach and mentor to junior PMs. Skilled facilitator and leader in matrix managed structures. Strong research professional with a Master\'s degree in Biomedical Science from University of East London. Therapeutic areas: Diabetes, Cardiovascular, Bone, Haematology, Opthalmalogy, Leukemia
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