Medical Director

Medical Director 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. 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. At 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, 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 or submit a request here #J-18808-Ljbffr Jobleads-US