Senior Medical Director

Overview

Physician providing medical expertise to ensure timely planning, designing, conduct, monitoring, and reporting of clinical trials.

Responsibilities

What you will be doing:

• Medical Leader Function representative of the CST
• Responsible physician for all medical aspects of clinical studies from Phase I to Phase III
• Contribute to trial oversight by monitoring safety of trial’s participants and integrity of trial’s data as documented in the Medical Monitoring and Oversight Plan
• Actively contribute to the review of study related listings and reconciliation
• Provide medical input in CRO/other vendors selection for the assigned clinical study
• Interact with medical counterparts at CRO/key opinion leaders
• Review of CRF and data management plan
• Contribute to the preparation of regulatory documents for CTA submission to Competent Authority and Ethics Committee/IRB including Briefing documents, IB, IMPD, and clinical study protocols, and ICFs
• Contribute to writing/review of site guidelines, laboratory manuals, other clinical study documents
• Provide training of CRAs, investigators, other trial personnel, and act as central point of contact for study-related medical questions in collaboration with selected vendors
• Contribute to identification and mitigation of safety risks as member of the safety management team
• Contribute to define, review and approve protocol deviations
• Contribute to definition and execution of CAPAs
• Actively contribute to the generation of the study results and review /approve SAP, mock TLFs, and CSR
• Participate to external communications/publications of the clinical study results

Qualifications

You are:

• MD with at least 7 years experience in the pharmaceutical industry in clinical research as a medical director role
• Experience in Immunology
• A working knowledge of Phase II – III drug development
• Strong leadership skills and a strategic thinker
• Energetic with a can-do attitude
• Medical practice experience for minimum 3 years
• English speaking and writing skills are required

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.