Director, Medical Affairs

Director, Medical Affairs
 
This is an exciting opportunity to join ICONs Medical Affairs department 
 
The role;

 • Provide line management for Medical Affairs team

 • *Ensure provision of al contracted activities and identification of out-of-scope activities on assigned projects. 

• *Provide medical monitoring for clinical studies. 

• *Serve as Program Lead Medical Monitor, if requested. • *Provide medical oversight to protocol-related medical and safety issues and communication of medical and safety issues to ICON staff and sponsors. 

• *Oversee and provide consultation for medical project data reviews, including lab report review, CRF safety review, and other study data

 • *Coordinate and provide medical training including therapeutic indication training, protocol training, safety presentations for ICON clinical staff, project teams, or during investigator meetings. 

• *Review and approve protocols, case report forms, informed consent forms (when applicable), and other miscellaneous study documentation, as requested. • *Review and approve final study reports or other clinical documents. • *Direct code-break activities (as appropriate). 

• *Oversee and mentor lower level Medical Affairs staff on assigned projects. • *Represent ICON Medical Affairs at internal and external teleconferences and meetings.

 • *Liase with Sponsors regarding project-related medical issues and provide medical consultation.

 • *Ensure quality of medical deliverables in accordance with project plans and ICON standards. 

• *Provide medical management oversight to assigned projects in accordance with established timelines, budget, quality standards and contractual requirements.

 • *Represent Medical Affairs in business development activities including general capabilities presentations, bid defences, medical costing estimates, and change order assumptions. 

• *Provide financial oversight to assigned projects ensuring revenue and margin targets are met. 

• *Provide consultation on protocol design and CDP (Clinical Development Plan), as appropriate.

 • Other activities as identified and requested by senior management.

• MBBS/MD, should be MCI certified
• Prior experience in Medical Affairs in CRO/Pharma Company
• Prior experience in Line Management