Senior Medical Director – Biotech

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:
To be successful in the role, you will have:

• Provide medical leadership on project teams
• Provide medical / scientific consultation and therapeutic expertise
• Oversee study specific medical/safety monitoring activities, ensuring compliance with ethical, legal, and regulatory standards as well as ICON and Sponsor SOPs
• Represent the Medical Affairs Department in business development activities
• Provide functional/departmental oversight in the absence of Vice President, Medical Affairs

Job Description
• *Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• *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 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.

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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