QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-house cross-functional development staff as well as CROs and contract workers to effectively deliver large and complex programs. Writing experience includes study concept documents, protocols, design of case reports forms (CRFs), clinical study reports, SOPs, and drafting study budgets. Also designed and implemented patient recruitment and retention strategies for global multi-centred clinical trials. Organized and conducted investigator meetings designed to effectively and efficiently train sites, launch trials and review clinical data. Therapeutic area experience includes cardiology, inflammation, oncology, and osteoporosis and nephrology.

Highlights:

• Data Management
• Management
• Nephrology
• Clinical Research
• Clinical Study Reports
• Drafting
• Oncology
• Project Management
• Project Manager
• Protocol