Shire Jobs

This Clinical Research Director (CRD) role in Early Neuro-Development is for a clinical expert of Alzheimer?s disease and is responsible for leading the development of clinical stage assets through IND-enabling studies, first-in-human studies, and proof-of-concept trials. More specifically, CRD is responsible for developing the clinical development plan, designing and executing clinical trials, analyzing trial data, interacting with regulatory agencies, and participating in internal decision making. CRD will work closely with the Global Project Head, Research Scientist, Clinical Pharmacologist, Biomarker Lead, Safety Medical Director, Statistician, Regulatory and other key functional leads. The role requires a strategically and operationally focused, resourceful, and well-organized individual with strong self-motivation, scientific excellence, outstanding interpersonal and analytical skills, and the ability to achieve multiple objectives and goals in parallel. Key responsibilities include: Responsible for the clinical development plans and clinical sections of integrated development plans (IDP). Contribute to the development of the product value proposition (TVP), target product profile (TPP) and market access strategy and the research strategy. Collaborate with other CRDs to ensure leadership, build consensus, coordinate action plans with stakeholders to resolve project-related study issues, and anticipate potential issues (sharing lessons learned) across the project or study teams. Review Boards (IRBs) and sites. Participate in medical review of aggregated data in ongoing trials, e.g., safety and stat outputs of blinded data. Assisted by related functions (e.g., clinical operations, project management, and procurement), responsible for timelines, budget, and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs). Lead the study specific committees, e.g., Independent Data-Monitoring Committee (IDMC), study steering committee, adjudication committee, with operational support. Co-Develop the SAP in collaboration with biostats. Responsible for key results preparation. Develop the Clinical Study Report (CSR). Contribute to briefing packages for regulatory meetings, PSP/PIP. Lead discussion at meetings with regulatory agencies. Ensure clinical data meets all necessary regulatory standards. Qualifications: Medical Doctor (MD) required, and a neurologist with clinical/research experience in Alzheimer?s disease is highly desired. Understanding of pharmaceutical product development and life cycle management gained through a minimum of 2 years of industrial experience or 5 years of relevant academic experience. Deep expertise in clinical development and methodology of clinical studies. Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with regulatory agencies. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it?s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks? gender-neutral parental leave.