Director, Epidemiology (Rare Oncology)

This is what you will do:

The Director of Epidemiology (Rare Oncology) at Alexion Pharmaceuticals is a senior strategic and scientific leadership position responsible for providing global epidemiological expertise and direction across rare oncology programs with minimal supervision. This role partners with cross-functional teams including Clinical Development, Regulatory Affairs, Patient Safety, Commercial, and Medical Affairs to develop and implement innovative epidemiology strategies that align with corporate objectives while ensuring all studies are executed efficiently, accurately, and in accordance with current methodological advancements. The Director serves as a technical authority in systematic literature reviews, secondary data analyses, observational studies, registries, and post-authorization safety studies, while also representing the Epidemiology and Real World Science department to external stakeholders such as regulatory authorities and scientific advisory boards. Key qualifications include demonstrated expertise in epidemiologic methods, observational study design and analysis, strong strategic thinking and planning abilities, excellent communication skills, and proven experience collaborating across functions to meet project objectives. The role encompasses mentoring and developing other epidemiologists, contributing to departmental strategic planning and process development, and actively engaging with the external scientific community through publications and presentations at industry conferences.

You will be responsible for:

• Accountable for developing the strategic & tactical plans for Epidemiology deliverables acrossassigned indications within Alexion’s rare oncology portfolio to support company objectives. 

• Accountable for executing deliverables (e.g. systematic literature reviews, database studies, analysis within primary observational studies/disease registries, PASS/PMCs) 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 areasge.

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

• Evaluating potential data sources and their applicability forreal-world evidence generation in support of Alexion’s oncology drug development. 

• Representingthe EpiRWSdepartment during interactions with key external stakeholders including Scientific Advisory Boards and regulatory authorities. 

• Building and handling relationships with the wider AstraZeneca Oncology R&D and Business Units to leverage existing expertise and access to data. 

• 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 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 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:

• Proven Epidemiological experience in the Oncology therapeutic area. 

• Excellent oral and written communication skills.

• Excellent attention to detail and quality, and scientificrigor.

• Strong interpersonalskills and ability to workeffectively in multidisciplinaryteams.

• High degrees of self-motivation and organization.

• Comfort in a fast-movingenvironmentwithfrequent changes in scope or direction of projects.

• Thorough and up-to-date technicalknowledge of epidemiology and relevant biostatisticsmethods.

• Experience and familiarityusing SAS or otherstatistical software packages.

• Evidence of productivity in epidemiologicalresearch as demonstrated by successful design, execution, and publication of epidemiologicalresearch, includingthrough extensive collaboration withexternalinvestigators.

• Record of high-quality publications in peer-reviewedjournals.