Medical Director Clinical Research (Inflammation/Rheumatology) for a worldwide biotechnology company

Responsibilities:

• Develops and executes medical strategies and provides scientific and medical input into the development of inflammation/rheumatology clinical programs.
• Leads the planning and execution of scientific deliverables outlined in the regional North American Medical Plan.
• Provides medical/scientific support for regional brand strategic objectives.
• Develops and manages key external and regional relationships according to the Key Opinion Leader Plan.
• As required, evaluates in-licensing opportunities.

• Will design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practices.
• Analyze and interpret study data and prepare reports for FDA and publication.
• Will serve as the primary medical monitor on assigned projects.

Requirements:

Basic Qualifications:

• MD with 2 or more years of clinical development and/or basic science experience.

Preferred Qualifications:

• Board certified or board eligible in inflammation/rheumatology or other related medical discipline.
• Strong background in inflammation/rheumatology and familiarity with clinical trials required.
• Additional experience in clinical medicine, pharmaceutical medicine preferred.
• 5 + years of clinical research experience and/or basic science research combined with clinical teaching and patient care.
• Knowledge of the disease states in the therapeutic area.
• A track record of related publications.
• Familiar with investigators or institutions in the therapeutic area.
• Documented success in leading, managing and motivating a staff.
• Experience supporting marketed products and commercial endeavors.
• Knowledge of regulatory affairs and drug safety issues.
• Ability to work well as part of a team.
• Excellent skills in both writing clinical documentation and presenting information.