Job Title: Director, Epidemiology - Hematology and Nephrology

Locaton: Mississauga, ON

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.

This is what you will do:

Hematology & Nephrology are exciting and fast-growing therapeutic areas within Alexion-AstraZeneca Rare Disease Unit. The Director, Epidemiology is a senior strategic and scientific leadership role that provides global direction and expertise for epidemiology support for programs within their therapeutic area, requiring minimal direction.  This role partners with cross-functional stakeholders to ensure appropriate epidemiological perspectives are provided in support of strategic needs and integrated into corporate plans. They are accountable for developing and implementing innovative, effective and impactful epidemiology deliverables,  ensuring all deliverables are performed efficiently, commensurate with budget, quality, accuracy, timeliness, and in accordance with current advancements in epidemiology / pharmacoepidemiology methodology.  To effectively accomplish this, they will develop a strategic plan for assigned indication(s) that aligns with corporate needs, and navigate policies to ensure successful execution. The role is directly accountable, either personally or through oversight of other epidemiologists/vendor/contractors, for all epidemiology deliverables and study results implemented within assigned indications.   

The role requires key interactions with senior leadership, routinely collaborating with leaders within Clinical Development, Patient Safety, Regulatory Affairs, Commercial / Marketing, Health Economics and Outcomes Research, Medical Affairs, Project Management, along with Global Program Team Leaders. 

Therefore, demonstrated experience in collaborating across functions in order to meet project objectives is key, along with the ability to assess and address team member needs through the use of skills such as but not limited to, influence, conflict resolution and negotiation.  They may also be called upon to represent the Epidemiology and Real World Science department in interactions with external stakeholders, such as Scientific Advisory Boards or regulatory authorities. 

The Director, Epidemiology may also participate in cross-functional initiatives in support of business or process improvement initiatives.  They may also represent the department in other cross-functional teams throughout the development lifecycle, and/or oversee other epidemiologists who participate on such teams. Within the Epidemiology and Real World Science department, they provide experienced technical guidance and mentoring to other epidemiologists.  They work with the Therapeutic Area Epidemiology Lead in the development of annual wholistic TA strategic plans. They may support the Global Head in the development and maintenance of department Standard Operating Procedures and Process Guides, as well as annual department objectives, which encompasses project planning, resource forecasting and assignments for assigned indications.

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

The Director, Epidemiology is a seasoned and developed technical expert across the department’s deliverables of detailed literature reviews, secondary data analyses, observational studies including patient/disease registries, PASS/PMCs, and epidemiologic input and oversight of REMS/RMPs.  In addition, they are well-versed in 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.

This position will oversee coordination of work with department personnel or contractors in the Epidemiology and Real World Science department.  Taking ownership for professional development is a crucial skill for this position.  Guiding and mentoring within the department are expected.  It is also expected that the position will routinely publish and present epidemiology projects at external industry conference/workshops, along with maintaining excellent relationships with external clinical advisors and epidemiological experts in the professional community.

You will be responsible for:

• Accountable for developing plan for Epidemiology deliverables (e.g. systematic literature reviews, database studies, analysis within primary observational studies/disease registries, PASS/PMCs, REMS/RMPs) for assigned indications within the therapeutic areas to support company objectives.

• Accountable for executing deliverables in accordance with the plan, either personally or through oversight of other Epidemiologists/vendors/contractors. 

• Accountable for providing epidemiology support to Clinical Development, Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the product life cycle.  Active participation on cross-functional therapeutic area teams.  Lead sub-team meetings as appropriate.

• Accountable for ensuring epidemiology perspective into company materials e.g. study protocols, case report forms (CRFs), and regulatory documents within assigned indications within the therapeutic areas.

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

• 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.

• Represent Epidemiology and Real World Science department and participate in corporate cross-functional business / process improvement initiatives.

• Actively participates in development and maintenance of Epidemiology and Real World Science department Standard Operating Procedures / Process Guides.

• Travel may be required (up to 10%).

You will need to have:

• PhD / DSc / DrPH in Epidemiology with at least 6 years proven experience in the pharmaceutical industry, biotechnology, or consulting environment, or MPH/MSc in Epidemiology with at least 10 years proven 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 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.

We would prefer for you to have:

• Excellent oral and written communication skills

• Knowledge of drug and clinical development process for genomic medicines

• Excellent attention to detail and quality, and scientific rigor

• Strong communication skills and ability to work effectively in multidisciplinary teams

• High degrees of self-motivation and organization

• Comfort in a fast paced environment with frequent changes in scope or direction of projects 

• Thorough and up-to-date 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, execution, and publication of epidemiological research, including through extensive collaboration with external investigators

• 2 years of line management or supervisory experience or equivalent

• Record of high-quality publications in peer-reviewed journals

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 E-Mail schreiben.

#LI-Hybrid

AstraZeneca 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.