Associate Director, Epidemiology - Barcelona, España - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Location:
Barcelona, Spain

Job reference:
R-186094

Date posted: 12/01/2023

This is what you will do:

The Associate Director, Epidemiology is a high-level strategic and scientific role accountable for developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology deliverables within the Neurology/Ophthalmology therapeutic area with a focus on post-approval studies including rare disease registries.

Through partnerships within cross-functional teams, this role ensures appropriate epidemiological perspective is provided in support of strategic needs and integrated into Alexion-AstraZeneca Rare Disease Unit's corporate plans.

The Associate Director, Epidemiology is accountable for developing a strategic plan for their assigned indications as well as leading the execution of epidemiology deliverables.

They will be responsible for executing all deliverables personally or through the oversight of vendors/contractors, ensuring all deliverables are completed efficiently 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 Neurology/Ophthalmology therapeutic area stakeholders across Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, Commercial, and Health Economics and Outcomes Research.

Therefore, demonstrated mature team-working behaviors and organizational awareness and insight are necessary.

The role will also interact with external stakeholders to ensure appropriate communication of epidemiological issues and study results, including Scientific Advisory Board members and regulatory authorities.

Ability to think strategically and leverage epidemiologic expertise and experience across multiple diseases is essential. Strong planning and execution ability, along with excellent communication skills, both written and oral are essential.

The Associate Director, Epidemiology is a technical expert across the Epidemiology and Real World Science department's deliverables of systematic literature reviews, secondary data analyses, and observational studies, including patient registries.

In addition, they are well-versed and experienced with epidemiologic methods including observational study design, analysis, and interpretation, methods used in the quantification of potential safety signals, disease epidemiology, and the determination of cause and effect relationships.

You will be responsible for:

Accountable for developing and executing plan for Epidemiology deliverables (e.g. systematic literature reviews, database studies, analysis within primary observational studies/disease registries) for assigned indications within the Neurology/Ophthalmology therapeutic area.
Accountable to propose, design, initiate, execute, and report epidemiologic study analyses conducted within observational studies, registries, or external databases within the Neurology/Ophthalmology therapeutic area.
Accountable for providing epidemiology support to Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the product development life cycle. Active participation on crossfunctional Neurology/Ophthalmology therapeutic area teams. Lead subteam 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 assigned indications within the Neurology/Ophthalmology therapeutic area.
Accountable for providing epidemiology perspective into study protocols, case report forms (CRFs), and regulatory documents for assigned indications within the Neurology/Ophthalmology therapeutic area.
Interact with authors, referees, and inhouse reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters based on data from observational studies.
Represent the Epidemiology-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 required (up to 10%)

You will need to have:

PhD / DSc / DrPH in Epidemiology with at least 3 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment, or MPH/MSc in Epidemiology with at least 6 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment.
The duties of this role are generally conducted in an office environment. As is typical of an officebased role, emp