Associate Director, Epidemiology

Associate Director, Epidemiology

16 Nov 2024
Massachusetts, Boston 00000 Boston USA

Associate Director, Epidemiology

Vacancy expired!

Job SummaryThe Associate Director, Epidemiology is a high-level strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and impactful epidemiologic research at a global level. The Associate Director, Epidemiology is the primary point of contact within the Epidemiology department for their assigned therapeutic area. The Associate Director, Epidemiology is accountable for development and execution of the Epidemiology Strategic Plan for their assigned therapeutic area. The Associate Director, Epidemiology is accountable for leading the execution of epidemiology analysis deliverables aimed at investigating natural history and treatment outcomes for their assigned therapeutic area. The Associate Director, Epidemiology will delegate and monitor work performed by contract personnel, and will also track external expenditures. The Associate Director, Epidemiology will participate in cross-functional teams and will lead sub-team meetings as appropriate. The Associate Director, Epidemiology will work closely therapeutic area stakeholders across Clinical Development, Pharmacovigilance, 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.Principal Responsibilities

Accountable for developing and executing Epidemiology Strategic Plan for their assigned therapeutic area.

Accountable to propose, design, initiate, execute, and report epidemiologic study analyses conducted within observational studies, registries, or external databases for their assigned therapeutic area.

Accountable for providing epidemiology support to Clinical Development, Pharmacovigilance, 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 epidemiology components of Regulatory materials (e.g., Orphan Drug Applications), Pharmacovigilance submissions (e.g., DSURs, PSURs, RMPs), and Pricing & Reimbursement (e.g., GVDs, GRDs) for their assigned therapeutic area.

Accountable for providing epidemiology perspective into study protocols, case report forms (CRFs), and regulatory documents for their assigned therapeutic area.

Delegate and monitor work performed by contract personnel.

Interact with authors, referees, and in-house reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters based on data from observational studies.

Represent Epidemiology 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 required (up to 10%)

Work Experience (Years, setting, etc.) 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.Education

PhD / DSc / DrPH in Epidemiology with 3 years of industry experience, or

MPH / MSc in Epidemiology with 6 years of industry experience

Major Skills (Technical & soft skills)

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

LI-KD1[[filter5]], [[filter1]][[filter4]]Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

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Job Details

  • ID
    JC2876309
  • State
  • City
  • Full-time
  • Salary
    N/A
  • Hiring Company
    Alexion Pharmaceuticals
  • Date
    2019-11-16
  • Deadline
    2020-01-15
  • Category

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