Serve as Modeling and Simulation (M&S) representative for clinical development projects. Act as a subject matter expert addressing technical and theoretical issues in the M&S area. Prepare and issue stand-alone M&S reports with minimal review. Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA - Prepare abstracts, posters, and manuscripts for external presentation and/or publication. Present at external scientific meetings as appropriate. Ensu... more details
Job title: Associate Director, Modelling and Simulation, PKDM
- Location: US / Bridgewater, NJ
- Job Type: Full time
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. Join our Pharmacokinetics, Dynamics, and Metabolism (PKDM) team as Associate Director, Modelling and Simulation, PKDM! you’ll serve as a clinical PK/PD expert participating in multidisciplinary teams for clinical phase development projects in different therapeutic areas.
This position is within Modeling and Simulation (M&S) group and offers an opportunity for the Associate Director to drive internal pipeline forward across various therapy areas. The Associate Director will conduct model-based analyses ranging from classical population PK, PK/PD models, disease progression modeling to advanced complex methodologies such as data analytics, machine learning (ML)and mechanistic modeling to strengthen decision making in driving internal pipelines forward with minimal supervision. This position will be based in Bridgewater, NJ.
Main Responsibilities:
- Serve as Modeling and Simulation (M&S) representative for clinical development projects. Act as a subject matter expert addressing technical and theoretical issues in the M&S area.
- Prepare and issue stand-alone M&S reports with minimal review. Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA
- Prepare abstracts, posters, and manuscripts for external presentation and/or publication.
- Present at external scientific meetings as appropriate
- Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.
About You:
- Education: Ph.D. with or without post-doctoral experience in Pharmacometrics, Biopharmaceutics, Pharmaceutical Sciences, Mathematics, Statistics, Data Science, Computational Biology, Chemical/Biomedical Engineering, System Pharmacology, Computer Science, or closely related discipline
- Experience: At least 5 years of industrial experience with a record of increasing responsibility and independence
- Technical expertise in several of the following areas ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
- Deep and extensive experience with advanced population modeling approaches (e.g., PPK, PKPD, etc. ) and complex methodologies such data analytic, AI/ML and mechanistic modeling.
- Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, Matlab, PKsim, SimCYP, Python
- Strong quantitative skills including but not limited to mathematics, statistics, data science, artificial intelligence/ machine learning (AI/ML), etc.
- Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
- Strong knowledge of industry best practices, global regulatory, processes, standards of drug development.
- Soft and technical skills
- Strong written and verbal communication skills, interdisciplinary collaboration, problem-solving, scoping and planning.
- Be able to operate in a multicultural environment and participate in international teams.
Why choose us??
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
