Associate Director, Modeling and Simulation, PKDM US

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:

• Develop modeling and simulation strategies for optimizing model-informed drug development in all stages of drug development, ranging from first in human dosing through life cycle management.
• Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward
• Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed.
• Develop and maintain a comprehensive understanding of global regulatory expectations and best practices for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing PKDM at regulatory meetings when needed.
• Champion PKDM internal/external visibility (e.g., authoring scientific publications, presentation at national and international conferences, participation in internal cross-functional initiatives, etc.).
• Provide scientific mentoring and support junior scientists and participate in the implementation of best practices within PKDM.

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
• Deep and extensive modeling experiences ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
• Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
• Extensive experiencesin M&S software such as NONMEM, R, Monolix, Phoenix NLME, Matlab, PKsim, SimCYP, Python
• Deep knowledge of industry best practices, global regulatory processes and standards of drug development.
• 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.