Medical Director, GDS

This is what you will do:The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion’s products by patients and healthcare providers. The Medical Director will be responsible for safety activities for investigational products and/or marketed, including identification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation. The Medical Director, Global Patient Safety will be supervised by Senior/Executive Director, Global Patient Safety.You will be responsible for:Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:Through data review and research, identifying for monthly Safety, Risk Management and Safety Science Management Team meetings, issues that could be potential signals for observed adverse events for further review and analysisChairing and/or directing the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closureRepresenting Alexion Global Patient Safety at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetingsDetecting, validating, and managing pre-and/or post-approval safety signals through to resolutionConducting medical review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in processEvaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as requiredIdentifying, initiating, and managing to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessaryOverseeing safety sections of documents and safety interactions with Regulatory authorities. This may include: authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAsYou will need to have:MD or equivalent degree or a life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experienceSound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problemsThe ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projectsKnowledge and understanding of GPS deliverables, standards and processesKnowledge and understanding of US and EU safety regulations pre- and post- marketingThe 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.We would prefer for you to have:2-3 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industryRare, Ultra-Rare or Orphan Disease Area experienceStrong verbal and written communication skills including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisionsExcellent, independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsMastery of Microsoft Word, PowerPoint and ExcelExpectation of working in the office 3 days a week: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable lawAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.#LI-RM1Date Posted25-Jun-2024Closing Date30-Aug-2024Alexion 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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Boston - MAType: Full time