17+ years of pharmaceutical clinical trial experience at Merck (15 yrs) and GSK (2 yrs).
Manage Clinical Trial Programs: supervise all clinical/operational aspects of a clinical trial program - site monitoring, design/implementation of protocols and clinical study reports (CSRs). Provide RN clinical expertise through entire clinical trial process. Deliver studies on time, within budget, and in compliance with ICH-GCP guidelines.
NEUROSCIENCE Therapeutic Area: Received Divisional Award 2012 and Award for Excellence for successful submission of NDA and subsequent FDA approval of drug. Responsible for new IND (prepared responses to FDA inquiries) and IND updates; managed clinical/operational aspects of 9 clinical trials, including site monitoring, protocols and clinical study reports. All were delivered on time, within budget and within ICH-GCP guidelines. Delivered Investigator Meeting presentations. Managed CROs. Co-authored publication (see below). Received Special Achievement Award 2002 for the successful management of the Neuroscience (Neuro, Psych, GI and Ophthalmology) budget. Also prepared capital budget and Long Range Operating Plan as well as cost-time estimates and participation in Capacity Planning Management analysis. Received Special Achievement Award 2002 for decreasing cost (10M) of clinical trials (restructured clinical personnel responsibilities).
ONCOLOGY Therapeutic Area: Received Divisional Award 2006 for the successful submission of NDA for Merck's first oncology drug and subsequent accelerated drug approval. Program management of 3 oncology compounds concurrently: responsible for clinical and operational aspects of 11 protocols and associated CSRs. Also, authored investigator's brochures, compound safety updates and risk management plans. ONCOLOLGY STAFF MANAGER: Received Divisional Award (2006) for creation of a staff training program in oncology that increased staff productivity and decreased cycle time.
REGULATORY AFFAIRS: Successful medical writer for drug labels and received Merck Special Achievement Award 2005 for FDA approval of new indication for a marketed Merck drug which led to increased sales. Worked with marketing and legal departments to review promotional and other product materials in accordance with DDMAC regulations.
Managed all aspects of data management for multiple programs concurrently. Received Impact Award 1997 for Process Improvement for the design, development and implementation of a fast track training program for RNs entering the pharmaceutical industry. Success was demonstrated by the nurses' ability to pass 3 core examinations. This led to increased productivity and decreased cycle time.
Self-employed with physical therapists, chiropractors, orthopedic physicians as clients. Responsible for all clients' accounts receivables including the successful negotiation of settlements of clients' claims in litigation. Increased client profit by 25% annually. Managed 5-10 contract employees.
Seeburger J, Taylor, Newman L, Friedman D, Ge Y, Zhang Y, Hustad C, LaSorda J, Harper Mozley L, Fan X. Hewitt D, Ho T, Connor KM, Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia, December 2010.
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