Director, Medical Affairs
About the role
This vacancy has now expired. Please see similar roles below...
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
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
Korea, South
Department
Clinical Monitoring
Location
South Korea
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a (CRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110107
Expiry date
01/01/0001
Salary
Location
United States
Department
Scientist
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Scientist
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109511
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Other
Job Type
Permanent
Description
As a Lead Learning & Development Specialist, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-110081
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Scientist
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Scientist
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109986
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109272
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109942
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins