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Senior Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell Therapy

Alexion Pharmaceuticals

This is what you will do:The Senior Medical Director, Clinical Development 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. May supervise 1-2 direct reports (Medical Directors for the program studies and/or Clinical Development Scientists) or provide medical oversight.You will be responsible for:Lead or support the clinical sub team and oversee the design and execution of multiple clinical studies or clinical programsRepresent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee)Supervise and develop Medical Directors and CDS and/or fellows; May lead a clinical subteam and oversee the preparation of a clinical development strategy. May 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 documentsDetermine appropriate advisory boards experts and lead the team in preparation for meetingsCritically 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 strategyLead the clinical sub team and oversee multiple studies for a given program. Serve as the Medical input to the Global Lead the clinical sub team and oversee multiple studies for a given program. Serve as the Medical input to the Global Development Team / Subteam and the Medical Expert for clinical study team.evelopment Team / Subteam and the Medical Expert for clinical study teamLiaise internally with other members of the clinical development team (including ClinDev Scientists) to drive overall program strategy and development plans. Represent Clinical Development at the Global Program TeamMaintain 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 reviewSupport business development activities, such as due diligence and research collaborationsMay serve as the Translational Science lead for one or more programsCritically 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 strategyDetermine appropriate advisory boards expertsWorking as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project managementMay supervise other medical monitors on individual studiesYou will need to have:MD or equivalent with expertise in nephrology10 plus years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)Experience as a medical monitor for clinical trials requiredRegulatory experience preferredPublication in peer reviewed journalsExcellent written / oral communication skillsAttention to detail and ability to think strategicallyWillingness to take on new responsibilitiesInterest and ability to learn about new therapeutic areasInterest in career progression and ability to take on a more senior roles in 1-3 yearsThe 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:Board CertificationPreferred: 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 preferredBasic statistical knowledge preferredUnderstanding of general (and specific) therapeutic principlesExperience designing and executing industry-sponsored clinical trialsBroad experience in the principles of clinical trial methodology, statistics, data analysis and interpretationExpert 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 data5+ years of industry experience in clinical developmentThe annual base pay for this position ranges from $ 288,059.20 - 432,088.80 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Date Posted12-Aug-2026Closing Date20-Sep-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.SummaryLocation: US - Boston - MAType: Full time

Vacancy posted 4 days ago
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