Director, Epidemiology

This is what you will do: 

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 supervision.  The Director, Epidemiology 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 cutting-edge, 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 executed within assigned indications.     

The Director, Epidemiology requires key interactions with senior leadership, routinely interfacing with leaders within Clinical Development, Global 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 stakeholder 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 expert 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 essential.  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 systematic literature reviews, secondary data analyses, observational studies including patient/disease registries and PASS/PMCs.  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 responsibility for professional development is a crucial skill for this position.  Teaching 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) 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 areasge. 

• 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 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: 

• 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 interpersonal skills and ability to work effectively in multidisciplinary teams 

• High degrees of self-motivation and organization 

• Comfort in a fast-moving 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