Medical Director Clinical Development
Medical Director Clinical Development
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Job Description
Introduction to role
The Medical Director Clinical Development will lead a crossfunctional team in the design and of clinical studies and provide input into global clinical development plans and strategies. The role supports the clinical development team and therapeutic area head with deliverables vital for effective and efficient clinical development plan design and .
Accountabilities
- Leading a team in preparation of clinical studyrelated documents including protocols charters statistical summary reports meeting presentations publications and clinical sections of regulatory documents
- Mentor and guide clinical development scientists and/or fellows
- Participating in Investigator planning and/or onsite initiation meetings
- of clinical trials
- Monitoring cleaning analyzing and reviewing safety and efficacy data to establish trends
- Managing a team in study including country and site selection site training and startup and data monitoring
- Data analysis and presentations
- Maintaining awareness of internal and external developments that could impact the development plan
Essential Skills/Experience
- MD or MD equivalent required
- Understanding therapeutic principles
- Knowledge in the principles of clinical research methodology statistics data analysis and interpretation
- Familiar with scientific literature searches and weighing of quality peerreviewed data
- Experience in running clinical trials in neurology indications and/or Rare Disease indications
- Basics of strategic vs. tactical thinking
- Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists
- Indepth knowledge of the multidisciplinary functions involved in a companys drug development process
- 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; engage in problemsolving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
Desirable Skills/Experience
- 5 years of industry experience in clinical development Residency training completion
- Prior experience in Neurology subspecialty certification
- Regulatory Authority interactions
- BLA or sBLA filing
When we put unexpected teams in the same room we ignite bold thinking with the power to inspire lifechanging medicines! Inperson working gives us the platform we need 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.
At AstraZenecas Alexion division we push the boundaries of science to transform complex biology into transformative medicines for rare diseases. Our unique position with global reach allows us to shape the future of rare disease treatment. We foster an environment where innovation thrives supported by a culture that values integrity inclusiveness and connection to patients lived experiences.
Ready to make a difference Apply now to join our team!
Date Posted
28Apr2025Closing Date
08May2025Alexion 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
