Director Medical Affairs

Job Description

Register or log in for contact information has an outstanding leadership position with an Oncology focus. The Director Medical Affairs will help pave the way for this international clinical research organization ( CRO ) to become among the top five of all CRO’s

Responsibilities:
Provide Quality Clinical Input/Medical Monitoring Services
• Analyze current research related to the therapeutic area involved in Sponsor clinical development
• Communicate with clients and Client Project Managers to promote project schedule adherence, ensure that projects are adequately staffed with personnel and resources, and meet high quality standards
• Interact with Sponsors and Medical Affairs group in protocol development and/or review
• Manage all aspects of medical monitoring specifically focusing on Oncology
• Interface with Sponsors and Regulatory authorities
• Interact with Clinical Safety department and Investigators regarding pharmacovigilance and study implementation

Requirements:
• Medical Degree (MD)
• Minimum 5 years industry and/or clinical trial experience with drugs, devices or biologics
• Minimum 3 years clinical trial experience
• Knowledge of the drug development process

Preferences:
• Board certification
• Medical License
• Management experience
• Experience with clinical development plans for products
• Experience working with or for a CRO.
• Experience with CDER, CBER, CDRH and international regulatory agencies