The position will report directly to the Vice President, Chief Medical Officer and ensure the plan, coordination, control, and continuous improvement of both content and processes of epidemiological studies in support of the Injectafer lifecycle management programs, Medical Affairs strategies, and regulatory activities.
Essential Duties and Responsibilities
- Provide scientific leadership and specific pharmacoepidemiology expertise using appropriate methodologies and analytical tools to characterize the natural history of diseases in target populations and standard of care therapies. The characterization of met and unmet needs in target patient populations will inform on the development of studies to inform on evidence gaps and key outcome measures.
- Provide scientific leadership to internal and external cross-functional stakeholders (Clinical, Medical, Regulatory, Safety, Marketing) to design, execute, analyze, and disseminate pharmacoepidemiology studies for products lifecycle management, payer evidence generation, and benefit-risk framework initiatives.
- Preparation of studies with vendors for real-world evidence generation and observational studies in an electronic medical record (EMR)-linked administrative databases.
- Assessment of literature to inform on the therapeutic use of branded products associated with target patient profiles, lifecycle management, and regulatory activities.
- Methodological contributions to the clinical trial design and statistical analysis plans.
- Scientific leadership and epidemiological contributions to benefit-risk frameworks, decisional framework analysis, safety surveillance, and risk management in pharmaceutical drug development.
Qualifications and Requirements
The candidate should have the knowledge, attitude, and leadership skills to conduct high-level pharmacoepidemiology studies that inform on evidence-based strategies aligned with clinical and business development objectives
These qualifications include, but are not necessarily limited to the following:
- Required doctoral degree from an accredited university in a public health field, preferably epidemiology, pharmacoepidemiology, bioinformatics, or biostatistics.
- Eight or more years in pharmaceutical drug development is required.
- Required proficiency in epidemiological methods, inclusive of incidence and prevalence estimates, natural history of disease data, systematic literature reviews, and use of EMR-enabled database studies.
- Demonstrated expertise in utilizing pharmacoepidemiology principles, methodologies, and databases for clinical development and/or safety surveillance.
- Highly motivated with outstanding attention to detail; efficient ability to create clarity for project objectives where there may be the initial ambiguity of the clinical or business development strategy.
- Synthesize findings and write regulatory reports for scientific presentations and publications.
- Knowledge of statistical software packages such as SAS or Stata and reference management documentation systems such as EndNotes.
- Ability to work overtime as needed.
- Travel up to 10% of the time with occasional additional time and effort for time-bound requests