Medical Director in immunology (Lupus SLE) serves as a medical responsible on clinical trial(s), overseeing execution of clinical trial activities in assigned projects. This role is client dedicated to top-5 pharma company • Ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials • Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies • Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents • Manage the clinical team supporting the clinical trial • Manage, mentor and develop assigned staff, as appropriate • Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders • Support the review, analysis and interpretation of study data • Support communication of study results as assigned EDUCATION & LANGUAGES • Medical Degree (mandatory) • Immunology experience (Lupus SLE) • Able to communicate effectively in English • Experience leading protocol development PROFESSIONAL SKILLS & EXPERIENCE • Requires substantial professional experience in related TA/indication including clinical trials • Professional experience in the execution of clinical trials as medical responsible (3+ years) • Previous experience in medical monitoring, medical data review, eligibility review during recruitment, presentations at investigator meetings and trainings, protocol writing, regulatory responses • Experience in design, set up, conduct and evaluation of clinical trials • Experience working in a cross-functional multi-site team environment • Working knowledge of GCP, ICH, US FDA and EMA regulations PERSONAL SKILLS & COMPETENCIES • Ability to work in an intense, fast paced, global work environment • Pro-active, problem-solving, constructive attitude • Strong oral and written communication skills, including presentations (posters, paper, seminars) to internal and external parties • Ability to collaborate in a seamless fashion with project/program/functional teams both face to face and remotely 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 maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. Interested 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. Are you a current ICON Employee? Please click here to apply