Director, Pharmacoepidemiology

Sanofi

Gentilly, France

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

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.

Main responsibilities

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.

About you

Experience:

Relevant work experience;
Extensive experience in the design and conduct of epidemiological studies;
Strong record of research publications in peer reviewed journals.

Skills:

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.