Job Description: The pharmacoepidemiology director provides support to marketed and investigational products in the Specialty Care Business Unit at Sanofi. Areas of focus include rare diseases, inflammation & immunology, and oncology.
Required Experience and Skills:
- Minimum five (5) years of relevant work experience
- Extensive experience in the design and conduct of epidemiological studies
- Strong record of research publications in peer reviewed journals
- In-depth knowledge of pharmacoepidemiology methods and data sources
- Ability to clearly communicate complex epidemiologic issues to both the scientific community and general public
- Written and verbal communication proficiency in English, including the presentation of data
- Demonstrated ability to formulate investigational plan and ability to work in pressure situations
- Excellent interpersonal skills and proven time management skills
- Performance-driven and proactively seeking creative solutions to problems
- PhD in epidemiology or MD/MPH or MD/PhD in epidemiology
- Prioritize activities across multiple projects in 1 or 2 therapeutic areas within the Specialty Care Business Unit (30% or 12 hours/week including ongoing studies related to pregnancy outcomes in alemtuzumab and teriflunomide patients – weekly meetings with key stakeholders in Global Pharmacovigilance, Biostatistics, Regulatory Clinical Development, Medical Affairs – prioritizing ad hoc data analysis requests to support FDA and/or EMA correspondence and submissions – internal meetings and presentations with senior management in the Multiple Sclerosis franchise)
- Lead the development of pharmacoepidemiological studies and observational PASSs, including design, conduct and interpretation in close collaboration with functions as needed (e.g. Global Pharmacovigilance, Regulatory, and Medical Affairs).
- Active participation in industry workshops and groups is anticipated and which will involve leadership on key initiatives and working groups as well as cross-collaboration with experts from academic, industry, and government organizations.
- Advise on pharmacoepidemiological principles including guidance on epidemiological study design to others within the R&D organization (including critiques of published studies or papers, critiques of statistical analysis plans for retrospective or prospective epidemiological studies, contextualizing signals identified through reporting of adverse events)
- Conduct epidemiological analyses that contribute to benefit-risk assessments of select products including synthesis of evidence on the real-world safety of products in the Specialty Care Business Unit.