Associate Director Epidemiology

Job Description

Job Summary:

• 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 Client 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.
• 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.

Duties and Responsibilities:

• 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 cross-functional Neurology/Ophthalmology therapeutic area teams.
• Lead sub-team 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 in-house 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%).

Education and Experience:

• Master’s or 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.
• Experience and familiarity using SAS or other statistical software packages.
• Experience executing observational/non-interventional post marketing regulatory studies.

Knowledge, Skills and Abilities:

• Excellent oral and written communication skills.
• Knowledge of drug and clinical development process.
• Excellent attention to detail, quality, and scientific rigor.
• Strong interpersonal skills and ability to work effectively in multidisciplinary teams.
• 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.
• Evidence of productivity in epidemiological research as demonstrated by successful design, execution, and publication of epidemiological research, including through extensive collaboration with external investigators.
• 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.

Physical Demands:

• 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.