Senior Medical Director, Clinical Development Hematology
Senior Medical Director, Clinical Development Hematology
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Job Description
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 Release
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 Hematology may lead the clinical subteam or support the clinical subteam 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 documents
Determine 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 crossfunctional 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 equivalent
510 years of clinical development experience preferably within industry
35 years minimum experience as a medical monitor for clinical trials required
Regulatory experience preferred
Track record of publication in peer reviewed journals preferably firstauthored publications
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
The duties of this role are generally conducted in an office environment. As is typical of an officebased 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 nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours
We would prefer for you to have:
Clinical specialty certification from US or foreign equivalent
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 crossfunctional team preferred
Formal training (certificate or graduate degree) in epidemiology clinical trials clinical research biostatistics is strongly preferred
Broad experience in the principles of clinical trial methodology statistics data analysis and interpretation
Understanding of general (and specific) therapeutic principles
Experience designing and executing industrysponsored clinical trials
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 indepth knowledge of the multidisciplinary functions involved in a companys 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 endresults
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
At 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.
#LIHybrid
Date Posted
06May2025Closing Date
26May2025Alexion 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 Alexion participates in EVerify.Required Experience:
Director
Employment Type
Full-Time
