Description
QualificationsEducation
- Required: BA/BS or equivalent qualification.
- Preferred: M.D., Ph.D., D.V.M., M.S., and/or Pharm.D or equivalent qualifications. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e .g . doctoral thesis, publications, research reports, etc).
Experience
- Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and processes . Track record of design, oversight and interpretation of clinical studies. Previous leadership / management experience or training.
Skills
- Demonstrated potential or ability to design, initiate and conduct clinical studies in industry, academic, or research clinic setting.
- Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.
- Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.
- Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines.
- Collaborative problem solving (handles conflict constructively).
- Creativity and/or ability to put innovative approaches into practice in clinical development.