Medical Director Clinical Research (Inflammation/Rheumatology) for a worldwide biotechnology companySeptember 23rd, 2019 by admin
- 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.
- MD with 2 or more years of clinical development and/or basic science experience.
- 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.