Senior Medical Director, Clinical Development

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 ReleaseWhen 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 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.The Role:The Senior Medical Director, Clinical Development Sciences may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings, as assigned by manager.You will be responsible for:Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs.Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees.Functionally, supervise and develop medical monitors and/or clinical development scientists (CDS), if any and as assigned by the manager.Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager.Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documentsDetermine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings.Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team.Conduct medical monitoring activities during periods of vacations, team restructuring, team departures or in other situations, as assigned by manager.Lead the presentation of clinical trial related information/data to senior management, as assigned by manager.Liaise internally with other members of the clinical development team to drive overall program strategy and development plans. Represent Clinical Development at the Global Program Team.Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.Support business development activities, such as due diligence and research collaborations, as assigned by manager.May serve as the Translational Science lead for one or more programs, as assigned by manager.Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager..Lead Pediatric Program Design and Execution, if applicable and as assigned by manager.Be accountable for the overall integrity of the data in the clinical trial.You will need to have:Physician with MD or foreign equivalent5-10 years of clinical development experience preferably within industry3-5 years minimum experience as a medical monitor for clinical trials requiredRegulatory experience preferredTrack record of publication in peer reviewed journals, preferably first-authored publicationsExcellent written / oral communication skillsAttention to detail and ability to think strategicallyWillingness to take on new responsibilitiesInterest and ability to learn about new therapeutic areasThe 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; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hoursWe would prefer for you to have:Clinical specialty certification from US or foreign equivalentPreferred: Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.5+ years of industry experience in clinical development is preferredExperience for medical responsibilities on a cross-functional team preferredFormal training (certificate or graduate degree) in epidemiology, clinical trials, clinical research, biostatistics is strongly preferredBroad experience in the principles of clinical trial methodology, statistics, data analysis and interpretationUnderstanding of general (and specific) therapeutic principlesExperience designing and executing industry-sponsored clinical trialsExpert in scientific literature searches and weighing of quality peer reviewed dataExperience authoring study essential documents, Clinical Study Reports, and regulatory documentsStrong relevant therapeutic area experienceAbility to clearly communicate to internal and external stakeholders orally and in writingExperience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-resultsAbility to prioritize multiple tasks and goals to ensure completion in a timely manner within budgetAbility to think both strategically and tacticallyAdvanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level dataAt Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.Ready to lead and inspire?Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.#LI-HybridDate Posted26-Nov-2024Closing Date09-Dec-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