Director Epidemiology Registries

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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

In this senior strategic and scientific role the Director Epidemiology provides global direction and leadership to the Alexionsponsored global Registry programs requiring minimal supervision. The Director Epidemiology is the primary point of contact within the Epidemiology department for the Alexionsponsored Registries supporting rare disease realworld evidence generation. The Director Epidemiology will have direct oversight of contract personnel and vendors associated with the planning implementation and of Epidemiology evidence generation activities within the Registries with deliverables aimed at publications and regulatory agency submissions. The Director Epidemiology also ensures all Registry analytical deliverables are performed in the most efficient manner possible commensurate with budget quality accuracy and timeliness and in accordance with current advancements in pharmacoepidemiology methodology. The Director Epidemiology will build a strategic plan for Registries that meets corporate needs and follows policies. The Director Epidemiology will collaborate with other therapeutic area lead Epidemiologists to ensure the appropriate epidemiological perspectives are provided in support of strategic needs and are incorporated into the plan.

The Director Epidemiology involves collaborating with various teams regularly working with Registry leadership within Clinical Operations Statistical Programming Data Management Patient Safety Regulatory Affairs Medical Writing Scientific Communications and Global Medical Affairs. Experience in collaborating across functions for project goals is essential. Understanding and meeting customer needs with skills like persuasion and negotiation are key. Additionally the Director Epidemiology may be tasked with representing the Epidemiology department in interactions with external partners such as Scientific Advisory Boards or regulatory authorities.

The Director Epidemiology may participate in crossfunctional initiatives in support of Alexion business or process improvement initiatives. The Director Epidemiology may also represent the Epidemiology department in other crossfunctional teams throughout the development lifecycle and provide guidance to other Epidemiologists who participate on such teams. Within the Epidemiology department the Director Epidemiology provides expert technical guidance to the Registries and mentoring to other Epidemiologists. The Director Epidemiology may support the Global Head in developing writing and maintenance of department Standard Operating Procedures and Process Guides as well as annual Epidemiology department objectives which encompass project planning and resource forecasting.

Ability to think strategically and leverage epidemiologic expertise and experience across a wide variety of diseases is essential. Strong planning and ability along with excellent communication skills both written and oral are essential. Additionally the Director Epidemiology is wellversed in and experienced with epidemiologic methods including observational study design analysis and interpretation methods used in quantifying potential safety signals disease epidemiology and determining causeandeffect relationships.

This position will oversee the conduct of work performed by contractors in the Epidemiology department. Taking responsibility for professional development of self and other colleagues are crucial skills for this position. Teaching and mentoring within the department are expected. It is also expected that the Director Epidemiology will routinely publish and present epidemiology projects at external industry conferences/workshops and maintain excellent relationships with external clinical advisors and epidemiological experts in the professional community.

Accountabilities

• Accountable for developing a strategic plan for Epidemiology evidence generation activities within the Alexionsponsored Registries to support company objectives.
• Responsible for leading all aspects of contract personnel and vendors to ensure Epidemiology evidence generation deliverables are completed in accordance with the plan.
• Accountable for serving as the primary point of contact within the Epidemiology department for the Alexionsponsored Registries providing Epidemiology leadership to Clinical Operations Statistical Programming Data Management Patient Safety Regulatory Affairs Medical Writing Scientific Communications and Global Medical Affairs.
• Accountable for ensuring epidemiology perspective into company materials e.g. study protocols case report forms (CRFs) and regulatory documents associated with the Alexionsponsored Registries.
• Interact with authors referees and inhouse reviewers on scientific manuscripts clinical conference abstracts presentations and posters.
• Represent the Epidemiology department during interactions with key external collaborators like 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.
• Represent the Epidemiology Department and participate in corporate crossfunctional business/process improvement initiatives.
• Actively participate in developing and maintaining Epidemiology department Standard Operating Procedures/Process Guides.
• Travel may be required (up to 10.

Essential Skills/Experience

• PhD / DSc / DrPH in Epidemiology with at least 6 years industry experience in the pharmaceutical industry biotechnology or consulting environment or MPH/MSc in Epidemiology with at least 10 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 employees must be able to: use a computer; engage in communications via phone video and electronic messaging; engage in problemsolving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

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 effectively in multidisciplinary teams
• High degrees of selfmotivation and organization
• Comfort in a fastmoving environment with frequent changes in scope or direction of projects
• Thorough and uptodate technical knowledge of epidemiology and relevant biostatistics methods
• Experience and familiarity using SAS or other statistical software packages
• Evidence of productivity in epidemiological research as demonstrated by successful design and publication of epidemiological research
• 2 years of line management or supervisory experience or equivalent
• Record of highquality publications in peerreviewed 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.

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Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.