Medical Director Pulmonology
Location: Remote (US)
This is an excellent opportunity to work within a fast paced environment within a culture derived from collaboration, partnership and accountability. ICON is a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
Position Summary
As a Medical Director, Pulmonology you will provide medical support to ICON project teams on clinical issues to ensure that clinical studies are conducted according to the highest ethical principles and in compliance with applicable legal and regulatory standards. You will provide therapeutic and drug development expertise and interact with Sponsors and investigative sites on protocol medical issues. Contribute to investigator meeting presentations, review study documentation, oversee safety data review, and provide medical support to Business Development.
Job Duties:
* Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
* As a manager, the employee is expected recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Travel (approximately 10%) domestic and/or international.
* Serve as Regional Medical Monitor on assigned projects and as Global Lead Medical Monitor, if requested.
* 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.
* Liaise 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 defenses, 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.
What You Need
Candidates Must Have a Medical degree with Board Certification in Pulmonology. Experience in clinical research, academia, pharmaceutical, biotech or other CRO industry preferred. We are seeking candidates with the ability to review and evaluate clinical data and excellent oral and written communication skills.
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