Design and provide oversight of clinical research programs. Build relationships with key opinion leaders and apply input to enhance study design and protocols. Assure that clinical research program design meets scientific objectives and is aligned with commercial needs. Serve as medical/scientific consultant to marketing or research project teams and government regulatory agencies. Establish the criterion essential for determining the safety, efficacy, and medical utilities. Interpret results of Phase I-III investigations in preparation for new drug or medical device application. May serve as safety expert for individual clinical projects. May be responsible for post marketing studies. Perform activities that focus on the clinical qualities and safety of products in the development phase. Domestic and international travel required up to 5%.

Special Requirements:

• 2 years of experience in patient care.
• 3 years of pharmaceutical/biotechnology experience, with 1 year of experience including accountability for medical oversight/evaluation or clinical development.

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time". Required expertise/knowledge includes:

• Experience with the definition of strategy of scientific research and dissemination.
• Experience maintaining relationships and permanent contact with KOLs and scientific societies.
• Experience with the definition, implementation and monitoring of studies and clinical trials initiated by investigators and supported as required by global clinical trials.
• Experience supporting and collaborating with regulatory area in presenting new products to national sanitary authorities and institutions.

• Experience actively collaborating with market access regarding the budget Impact Analysis and Pharmacoeconomics studies.