Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.Senior Medical Director Bone MetabolismLocation: Barcelona, SpainReports To: Vice President, Clinical Development, NF1 & Bone Metabolism, Alexion and dotted line to the Head of External Scientific EngagementThis is what you will do:The Senior Medical Director Bone Metabolism is responsible for overseeing 2 or more programs, providing oversight/guidance/mentoring to the Clinical Development, Clinical Operations, and business development organizations, serving on cross-asset strategic teams (e.g., disease strategy team) and providing input to strategic decisions at the Therapeutic Area (TA) Strategy Team and Global Medicine Team meetings. Manages Associate Directors and clinical scientists directly and may support/oversee other staff within the TA. Provides overall support to regulatory strategy and commercial strategy when required.The Senior Medical Director Bone Metabolism is also responsible for early identification of Key HCPs networks for Bone Metabolism indications (at the Global level), setting up & maintaining robust relationships with Global Strategic Consulting Groups in key areas of interest, and working cross-functionally with all relevant internal stakeholders (COM, ClinDev, ClinOps, PAG, Reg, Access) to define SCG agenda and key questions to address/insights to collect. He/she will also establish Strategic Scientific Engagement Plan for the MACT (Medical Advisor Clinical Trials) Team: drive MACT local execution, studies prioritization (with COM & MACT), collaborate with MACT Study Lead to create appropriate material, and define Strategic Engagement Plan at national/regional level.You will be responsible for:Typically leading 2 program teams and driving the successful execution of clinical studies/programs/research strategies; defining and managing the benefit to risk profile of our products.Representing Clinical Development on the Global Program Team (GPT) and Global Medicine Team in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee); advancing understanding of the impact our therapies have on the pathophysiology of rare and orphan diseases through scientific discourse and interpretation of data.Fostering the development of Medical Directors and Clin Dev Scientists and/or fellows. Leading and overseeing 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine, and business development functions and leading and/or overseeing clinical activities to support due diligence.Acting as an expert consultant on Bone metabolism to the Vice-President and Therapeutic Area Head, as well as to other Senior Executives in Alexion and AstraZeneca.Representing Alexion Clinical Development in Bone Metabolism to Key External Stakeholders & Patients Associations.Establishing & maintaining close relationships with relevant Global Consulting Groups & driving proper execution of External Scientific Engagement Plan at Regional/National level with the MACT team.Representing Alexion Clinical Development to internal (R&D management, cross-functional development teams, and executive committee) and external (academic, regulatory, and medical) communities.Overseeing a cross-functional team which develops the clinical components of the Clin Dev Plans. Serving as the Clinical input to Global Development Team/Subteams and medical expert for the clinical study teams. Overseeing the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses.Liaising internally with other members of the CDP to drive program strategy and CDPs. Coordinating communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science) as it relates to clinical development study design, execution, and interpretation of results. Serving as the medical expert on the global product labeling team.Driving awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation.
#J-18808-Ljbffr