Associate Director of Planning

3 days ago

Mississauga, Canada AstraZeneca GmbH Full time

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
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