Medical Director, Clinical Development

Introduction to role

The Medical Director, Clinical Development will lead a cross-functional team in the design, and execution 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 execution.

Accountabilities

• Leading a team in preparation of clinical study-related 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, execution and/or on-site initiation meetings
• Execution of clinical trials
• Monitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish trends
• Managing a team in study execution, including country and site selection, site training and start-up, 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 peer-reviewed 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
• In-depth knowledge of the multidisciplinary functions involved in a company’s drug development process
• 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; engage in problem-solving and non-linear 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, sub-specialty 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 life-changing medicines! In-person working gives us the platform we need 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.

At AstraZeneca's 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!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.