Global Development Medical/Science Senior Director

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality! If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.As a Global Development Medical/Science Senior Director with a focus on Cardiovascular/Renal or Metabolic dysfunction (including Diabetes, Obesity and NASH/MASH), you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The successful Global Development Medical/Science Director in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases) will be responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards to align with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.What you will do:Medical expert accountabilitiesProvide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical studyBe accountable to deliver medical information, answers, and clarifications to Regulators, Ethics Committees, Marketing Companies, Investigators/SitesTrial conduct and hands-on delivery accountabilitiesAccountable to the Global Clinical Head (GCH) for the medical aspects and design of studies. Also responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues with the study teamOversight of medical and ethical components of studies including patient safety in compliance with GCPDeliver all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)Conduct safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and escalation to the GCH/Global Safety Physician when neededBe medically accountable for international investigator meetings, and support Marketing Companies in national activitiesApprove, with the GCH, the Clinical Study Report; including preparation and production (Introduction, Results, Discussion)Messaging and external impact accountabilitiesMaintain a high degree of understanding and awareness of new and emerging medical developments, globallyApply strategic intent  when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca productsProvide guidance for investigator-initiated trials in collaboration with regional marketing companies Basic Qualfications:Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree OR PhD or PharmD with specialty or experience in the Cardiovascular, Renal or Metabolism (including obesity, diabetes, MASH) therapeutic areas, 5+ years of pharmaceutical industry experience  OR 5+ years of clinical research experience in the academic or clinical practice settingDemonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and culturesFluent in oral and written English, with good presentation skills and effective communication Desired Qualifications:Clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial resultsExperience/clinical training focused in cardiology or metabolismCredibility in scientific and commercial environmentsPharmaceutical industry and experience working with late stage trials strongly preferredWhen we put unexpected teams in the same room, we unleash 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.As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here:    Kendall Square Press ReleaseWhy AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.Date Posted31-Oct-2024Closing DateOur mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.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