Experience in any of the following therapeutic areas:
Pulmonology/Respiratory, Neurology/Immunology, Cardiovascular/Coagulation or Internal Medicine
Location: RTP, NC
This position is responsible for assessment of clinical feasibility and strategic planning of clinical trial programs (Phase I thru Phase IV). This individual must become an expert in the field of study and lead and moderate investigator and other medical advisory meetings with clinical experts and is the clinical point person as an internal expert in the assigned area. Key participant in health authority meetings and is responsible for final protocols, assessing safety and other clinical data on an ongoing basis during clinical studies to assess drug safety and continued optimization of strategic direction. The Sr. Medical Director is responsible for interpretation, analysis, and final content of Clinical Research Study Reports and other Clinical Research documents and for content of all documents submitted to FDA and the International Regulatory Agencies (Clinical Reports, Briefing Booklets, New Drug Applications or Biological License Applications, Investigator Brochures, Periodic Safety Update Reports etc). This position will also be responsible to provide MD input and final review into key study manuals and other documents necessary for study conduct.
Qualifications :
Requirements for this position is a Medical Degree (MD). Candidate must have at least 10 years directly related pharmaceutical industry experience (exception – up to 5 years of medical experience can also be recognized as equivalent experience) of which 2-3 years must be as a Project Director. The position requires medical, scientific and technical expertise, including the ability to translate basic and preclinical data to key external and internal teams for appropriate important clinical development.
