Associate Director, Epidemiology

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform 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.

Introduction to role

The Associate Director, Epidemiology is a strategic and scientific leader responsible for developing, coordinating, and completing impactful epidemiology deliverables within the Koselugo program. This role involves overseeing the development, incorporation, and analysis of Alexion’s studies, either personally or through the management of other Epidemiologists or vendors/contractors. The goal is to enhance the understanding of disease natural history, treatment outcomes, and drug safety evaluations. The Associate Director will ensure all deliverables are completed efficiently, within budget, and with high quality and accuracy.

The Associate Director will participate in cross-functional teams and lead sub-team meetings as needed. This role involves closely working with collaborators from Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial. The ideal candidate will have experience in analyzing and interpreting epidemiologic data within the context of rare diseases and a passion for applying epidemiology to support life-transforming therapies for patients.

Accountabilities

• Responsible for developing and completing Epidemiology deliverables associated with the Koselugo program
• Coordinate and oversee the planning and execution of analyses from Koselugo studies. Provide oversight and guidance to statisticians and programmers in developing analytic deliverables.
• Propose, design, initiate, complete, and report epidemiologic study analyses conducted within observational studies, registries, or external databases for assigned indications
• Summarize results in written reports and oral presentations
• Provide epidemiology support to Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the development life cycle. Actively participate in cross-functional therapeutic area teams and lead sub-team meetings as appropriate
• Provide epidemiology perspective into study protocols, case report forms (CRFs), and regulatory documents for assigned indications
• Interact with authors and in-house reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters based on data from observational studies
• Represent Epidemiology and Real World Science department during interactions with key external customers like Scientific Advisory Boards and regulatory authorities
• Critically appraise and synthesize relevant epidemiological literature
• Maintain awareness of epidemiology with respect to regulatory requirements, payer trends, and advancement of pharmacoepidemiology methods
• Travel may be required (up to 10%)

Essential Skills/Experience

• At least 3 years of industry experience in the pharmaceutical industry, biotechnology, or consulting environment for Doctoral-level candidates, or 6 years of industry experience for Master’s-level candidates
• PhD / DSc / DrPH in Epidemiology with 3 years of industry experience, OR MPH / MSc in Epidemiology with 6 years of industry experience

Desirable Skills/Experience

• Excellent oral and written communication skills
• Knowledge of drug and clinical development process
• Excellent attention to detail and quality, and scientific rigor
• Ability to work under pressure and lead by example
• Strong interpersonal skills and ability to work effectively in multidisciplinary teams
• Thorough and up-to-date technical knowledge of epidemiology and biostatistics methods
• Experience and familiarity using SAS for statistical analysis
• Record of high-quality publications in peer-reviewed journals

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.

#LI-Hybrid

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.