This is what you will do:
The Associate Director, Epidemiology is a high-level strategic and scientific role accountable for developing, coordinating, and implementing ground breaking, effective, and impactful epidemiology deliverables within the Global Hypophosphatasia Registry. This role has responsibility for leading all aspects of the development, incorporation, and analysis from Alexion’s rare disease registries either personally or through oversight of other Epidemiologists or vendors/contractors, with results sought at improving understanding of the natural history of disease, treatment outcomes, and drug safety evaluations. They will ensure all deliverables are completed efficiently, and commensurate with budget, quality, accuracy, timeliness, and in accordance with current advancements in epidemiology / pharmacoepidemiology methodology.
The Associate Director, Epidemiology will participate in cross-functional teams and lead sub-team meetings as appropriate. They will work closely with therapeutic area stakeholders across Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial, and must have mature team-working behaviors and organizational awareness and insight. The Associate Director, Epidemiology will also interact with external stakeholders to ensure appropriate communication of epidemiological issues and study results, including Scientific Advisory Board members and regulatory authorities. The ideal candidate will have prior experience with analysis and interpretation of epidemiologic data within the context of rare disease, and will be passionate about the application of epidemiology to support developing and delivering life-transforming therapies for patients.
You will be responsible for:
- Accountable for developing and implementing Epidemiology deliverables from the Global HPP Registry
- Coordinate and oversee the planning and execution of analyses from the Global HPP Registry. Provide oversight and mentorship to statisticians and programmers in development of analytic deliverables.
- Accountable to propose, design, initiate, execute, and report epidemiologic study analyses conducted within observational studies, registries, or external databases for their assigned indication(s)
- Summarize results in written reports and oral presentations.
- Accountable for providing epidemiology support to Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the development life cycle. Active participation on cross-functional therapeutic area teams. Lead sub-team meetings as appropriate.
- Accountable for providing epidemiology perspective into study protocols, case report forms (CRFs), and regulatory documents for their assigned indication(s).
- 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 stakeholders including Scientific Advisory Boards and regulatory authorities.
- Critical appraisal and synthesis of 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%).
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.
You will need to have:
- At least 3 years of proven 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
We would prefer for you to have:
- 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 optimally in multidisciplinary teams
- Detailed 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
Alexion Canada
Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.
Our Canadian team
We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.
How We Work
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.
Alexion 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. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
