As a Senior Medical Director, Biotech you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. + **What you will be doing:** + Leads the Clinical Development (CD) Team, a cross functional, multinational team of internal experts, through clinical phase II – III trials through global product registration, as well as supporting product life cycle optimization. + Sets project-related objectives with Global Project Team (GPT) members and provides input to their annual performance evaluation (PMP completed by the functional line manager). Requests CD team members and clarifies resource availability with global functional heads + Member of the Global Project Team and member of the Global Brand team, representing CD + In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower). Responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources. Proactively initiates corrective action as needed. + Responsible for the ongoing risk-benefit assessment of a compound until approval in a main country. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate + In consultation with the Nucleus Head, Global Clinical Program Excellence Leader (GCPEL) and relevant Product Team (PT) members, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepares assessments and recommendations at Decision Points and presents them together with the GPL to the Development Management Committee. + Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (e.g. briefing document, submission package). Compiles and maintains Investigators’ Brochures + Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and defines together with Medical Affairs the publication strategy. Approves publications and ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail. + Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development. + Provide medical assessment of in- and out-licensing opportunities of development projects, foster patient-centric trial designs, and consider patient involvement in clinical development and trial design planning + Approves domestic study concepts to ensure compliance with global strategy. **You are:** + Biotech Expertise: Experience in pre-revenue biotech environments, particularly those who have successfully advanced drugs through registration. + Regulatory Experience: Must have direct experience interacting with regulatory agencies and overseeing the process of bringing a drug to market. + Cultural Adaptability: Candidates should be able to navigate the cultural differences between German and American working styles, ensuring seamless integration into the team. + Strategic & Creative Thinking: Ideal candidates should be open-minded, innovative, and solutions-oriented, embracing the client's emphasis on out-of-the-box thinking and agility. + **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/benefits 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, 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-accommodations 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.