Posted 3 days ago

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

BP01 Alexion Pharmaceuticals Inc Company United States of America, US - Boston - MA
Onsite Full Time

Job description

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 programs Represent 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 documents Determine appropriate advisory boards experts 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 Lead 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 team Liaise 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 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 May serve as the Translational Science lead for one or more programs 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 Determine appropriate advisory boards experts Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management May supervise other medical monitors on individual studies You will need to have: MD or equivalent with expertise in nephrology 10 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 required Regulatory experience preferred Publication in peer reviewed journals Excellent written / oral communication skills Attention to detail and ability to think strategically Willingness to take on new responsibilities Interest and ability to learn about new therapeutic areas Interest in career progression and ability to take on a more senior roles in 1-3 years The 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 hours We would prefer for you to have: Board Certification Preferred: 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 preferred

Experience

for medical responsibilities on a cross-functional team preferred Basic statistical knowledge preferred Understanding of general (and specific) therapeutic principles

Experience

designing and executing industry-sponsored clinical trials Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation Expert in scientific literature searches and weighing of quality peer reviewed data

Experience

authoring study essential documents, Clinical Study Reports, and regulatory documents Strong relevant therapeutic area experience Ability to clearly communicate to internal and external stakeholders orally and in writing

Experience

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-results Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget Ability to think both strategically and tactically 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 The 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 Posted 12-Aug-2026 Closing Date 20-Sep-2026 Our 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Skills and functions

  • Sales