Director, Epidemiology

Provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates Guide and advise clinical development study teams on the design and collection of natural history data to better understand disease progression including risk factors and optimal endpoints for use in clinical trials Use real-world and clinical data to refine population size and characteristics for disease targets as clinical development progresses, in both rare disease and prevalent disease areas. Partner with Clinical Research and GPSRM to help interpret and refine potential safety signals during drug development. Partner with Biostatisticians and Statistical Programming to implement, provide technical oversight of analyses from natural history & other observational studies to support clinical development and the preparation of scientific publications, presentations and abstracts. Provide strategic and tactical expertise on the development of RWE for external comparators including advisement on the appropriate methodology for the use of RWE for regulatory purposes. Support regulatory submission activities including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers and provide scientific leadership on the design post-marketing commitment studies Partner with GPSRM to deliver and provide oversight for REMS, risk management plans and post-approval safety studies. Author epidemiology sections of DSURs and PRBERs. Investigate and understand potential safety signals for marketed RNAi therapeutics. Establish real-world data partnerships in collaboration with Medical Affairs and Commercial and coordinate acquisition of real-world data to avoid duplication Provide leadership in the development of innovative RWE approaches, techniques, and standards to be used across teams Mentor junior epidemiologists and RWE/observational analysts to ensure competence in epidemiologic skills and knowledge PhD in Epidemiology or other Quantitative Public Health discipline Experience applying epidemiologic methods in at least one disease area, preferably using pharmacoepidemiologic techniques Ability to deliver complex epidemiological studies in a regulated environment with moderate supervision At least 5 years of experience in the pharmaceutical industry or equivalent experience in an academic or government setting Current knowledge of emerging guidance from various regulatory authorities on the design of observational studies and the use of real-world data to support decision making. Current knowledge and expertise in emerging analytical methodologies, tools and applications to ensure fit-for-purpose and innovative approaches on the use of RWD to address pertinent questions. Effective communication skills both at the lay and technical level to inform stakeholders on the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions Ability to succeed in a matrixed environment with multiple stakeholders Ability to successfully manage priorities, resources, and performance targets Knowledge of private and public use datasets for the conduct of epidemiological studies Basic knowledge of regulatory requirements in the pharmaceutical industry Proficient written and communication skills