Medical Director

ICON plc

4d • Remote

About The Position

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 on our mission to shape the future of clinical development. We are seeking an experienced Medical Director to play a critical role in supporting patient safety throughout the lifecycle of ICON’s innovative therapies. In this position, you will drive medical safety strategy, evaluate safety data, support key decision-making, and collaborate closely with both internal and external stakeholders to promote the safe and effective use of our products. Preferred locations: East Coast US. The Medical Director serves as the primary point of accountability for ensuring patient safety and the safe use of assigned ICON products in both development and commercial settings. The Medical Director leads the evaluation of medical safety data and provides strategic safety guidance for assigned program(s). In this role, the Medical Director is responsible for shaping and executing the overall safety strategy and approach for safety-related activities. Responsibilities include providing expert medical safety leadership and oversight, ensuring end-to-end ownership of safety activities, and guiding the assessment of safety data to support informed business and clinical decisions. The role also involves close collaboration with internal stakeholders including Regulatory Affairs, Clinical Development, and Medical Affairs, as well as external partners such as key opinion leaders and regulatory authorities, to align safety communications and support the safe and effective use of ICON products. You will report to the (Asset) Medical Safety Lead.

Requirements

• MD degree
• Minimum of 7 years of relevant pharmaceutical/biotech industry experience, including at least 5 years within pharmacovigilance/drug safety (global experience preferred)
• Clinical practice and/or academic medicine experience is considered an asset
• Working knowledge of global pharmacovigilance regulations and guidance documents
• Demonstrated ability to perform medical review and assessment of safety data from multiple sources
• Experience authoring complex documents and supporting regulatory submissions
• Knowledge of adverse event reporting systems
• Strong scientific reasoning and analytical capabilities
• Excellent ability to interpret, synthesize, and communicate medical safety data from multiple sources
• Strong leadership skills with the ability to motivate, influence, and collaborate across multidisciplinary teams
• Excellent presentation and communication skills, with the ability to clearly convey complex information
• Strong computer proficiency, including Microsoft Office applications
• Fluent in written and spoken English

Nice To Haves

• Experience in epidemiology, biostatistics, clinical development, or medical affairs is considered a plus

Responsibilities

• Provide strategic medical safety leadership and hands-on support for assigned product(s) within a cross-functional environment
• Develop safety strategies and deliver accurate, timely, and high-quality safety input for global regulatory submission documents (e.g. ISS, SCS, narratives) for assigned product(s)
• Conduct safety signal detection and benefit-risk assessment activities, along with routine and ad-hoc aggregate safety data reviews for assigned product(s)
• Lead cross-functional discussions and reviews of existing and emerging aggregate safety data for assigned product(s)
• Contribute to the advancement of the overall safety governance framework and related activities
• Draft and/or review safety sections of clinical and regulatory documents (including study protocols, IBs, Clinical Study Reports, and ICFs)
• Provide medical safety expertise in responses to regulatory authority questions and ensure safety information is complete, accurate, and submitted in a timely manner
• Lead the preparation of periodic safety reports (e.g. PSUR, DSUR), ensuring consistency, quality, and appropriate medical safety content
• Oversee the medical review and assessment of individual case safety reports (ICSRs)
• Confirm reporting criteria and content for expedited reporting and unblinding activities (e.g. SUSARs or urgent safety matters)
• Lead or contribute to the preparation and presentation of safety data for Data Safety Monitoring Board (DSMB) meetings
• Provide medical safety support during internal audits and regulatory inspections
• Assist with the development and maintenance of GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
• Support adverse event reporting training and cross-functional pharmacovigilance awareness initiatives
• Support the preparation and review of pharmacovigilance agreements with clinical development and commercial partners
• Participate in cross-functional initiatives and project teams
• Perform additional responsibilities as needed to support departmental objectives

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree