Bio Analytical Manager
Breakthrough science. One moment, one day, one person at a time.
HIGHLIGHTS OF EXPERIENCE-Managed simultaneously over forty clinical trials in various phases, from study initiation to close, of four molecules with globally-based teams and two molecules with local based teams. -Strong project management skills and problem solving within a fast paced global environment-Two of the four molecules supported have received FDA approval in the past year-Negotiated over thirty vendor contracts with external bio-analytical companies to support clinical trials, terms included: deliverables, time-lines and budgets (ranging from $25,000 to greater than $1,000,000; realizing cost savings of $5,000 to $100,000 depending on contract) -Interfaced with multiple functional departments (internal and external) to ensure bio-samples are tested according to protocol and in compliance with industry standards-Worked with other functional groups on progresses and identified gaps to streamline the processes.-Assisted in the development, validation, and review of results for hematology and clinical chemistry mechanism-based biomarker assays required for oncology and metabolic disease compound screening-Participated in over twenty non-GLP Toxicology Studies in the therapeutic areas of oncology and metabolic disease, advancing more than a dozen small molecule compounds to Investigational New Drug (IND) status-Productive worker in a team environment, as well as being able to work independently with minimal supervision-Identified potential toxicities for potential development candidate compounds, by developing novel in vitro assays, allowing the project team to arrive at a quicker 'no-go' decision
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