Ampharma Solutions

Experienced Project Manager with expertise in drug substance and drug product development and experience in managing early stage clinical trials. Therapeutic areas include Oncology, CV, Respiratory and Inflammation. A strong leader with the ability to motivate multidisciplinary teams. Provides clear vision to team members, motivating and empowering to accomplish objectives. AMPharma Solutions Offers Deliver Drug substance Manage CRO to deliver cGMP API for clinical studies. Manage quality, cost and time from early clinical to commercial manufacture Deliver Drug Product Manage CRO and deliver drug product for clinical studies to commercial manufacture. Experience in solid dosage forms, parental, extended release and inhalation. Regulatory Interactions Write and review Regulatory documentation for clinical studies. Experience in participating in Regulatory interactions with Health Authorities Manage Supply Chain Manage supply chain of the drug substance and drug product for safety, early clinical studies and all the way through to commercial supply. Manage Early Phase clinical studies Manage CRO on behalf of the customer to deliver early phase clinical studies Mentoring and coaching Reinforcing the important role that leadership plays in drug development, with mentoring and coaching for managers and senior leaders