Medical Director, Clinical Development

Company: Alexion Pharmaceuticals
Location: Boston
Posted on: February 4, 2025

Job Description:

Introduction to roleThe Medical Director, Clinical Development will lead a cross-functional team in the design, and execution of clinical studies and provide input into global clinical development plans and strategies. The role supports the clinical development team and therapeutic area head with deliverables vital for effective and efficient clinical development plan design and execution.AccountabilitiesLeading a team in preparation of clinical study-related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documentsMentor and guide clinical development scientists and/or fellowsParticipating in Investigator, planning, execution and/or on-site initiation meetingsExecution of clinical trialsMonitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish trendsManaging a team in study execution, including country and site selection, site training and start-up, and data monitoringData analysis and presentationsMaintaining awareness of internal and external developments that could impact the development planEssential Skills/ExperienceMD or MD equivalent requiredUnderstanding therapeutic principlesKnowledge in the principles of clinical research methodology, statistics, data analysis, and interpretationFamiliar with scientific literature searches and weighing of quality peer-reviewed dataExperience in running clinical trials in neurology indications and/or Rare Disease indicationsBasics of strategic vs. tactical thinkingExperience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientistsIn-depth knowledge of the multidisciplinary functions involved in a company's drug development processThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Desirable Skills/Experience5+ years of industry experience in clinical development Residency training completionPrior experience in Neurology, sub-specialty certificationRegulatory Authority interactionsBLA or sBLA filingWhen we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.At AstraZeneca's Alexion division, we push the boundaries of science to transform complex biology into transformative medicines for rare diseases. Our unique position with global reach allows us to shape the future of rare disease treatment. We foster an environment where innovation thrives, supported by a culture that values integrity, inclusiveness, and connection to patients' lived experiences.Ready to make a difference? Apply now to join our team!Date Posted22-Jan-2025Closing Date29-Apr-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.SummaryLocation: US - Boston - MAType: Full time

Keywords: Alexion Pharmaceuticals, Manchester , Medical Director, Clinical Development, Executive , Boston, New Hampshire