Medical DirectorAssoc. Medical Director (HOMEBASED in North America)

The primary responsibilities of this position include medical management of Serious Adverse Events (SAEs) and medical oversight of clinical trials to ensure company Standard Operating Procedures, sponsor directives, and regulatory requirements are followed. Other responsibilities include medical review of clinical study reports, attending and presenting at investigator and sponsor meetings, providing medical consultation to sponsors and project team members for clinical trial activities including timeframe business development through marketing application. Education and Experience: MD degree with active US license (Board certified: Oncology) **Candidates with no industry exp. will be considered at an Assoc MD level or will consider experienced industry professionals at a Medical Director level. Knowledge, Skills and Abilities: Strong medical knowledge. Strong analytical skills. Excellent oral and written communication skills. Excellent interpersonal and team building skills. Excellent negotiating skills. Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information, and problem solve. Ability to exercise creativity and judgment. Understanding of regulatory guidelines for adverse event reporting for seriousunexpected events. Working knowledge of Federal Guidelines and GCPs. Familiar with guidelines for IND and NDA submissions and international guidelines for conduct of clinical studies. Working knowledge of biostatistics, data management, and clinical operations procedures. Overall knowledge of the drug development process PPD is an Equal Opportunity Employer **This position can be based out of any of PPDs North American offices or home-office based.