Director, Pharmacokinetics, Dynamics and Metabolism
Cambridge, MassachusettsBridgewater, New Jersey Permanent Date posted 05/06/2024
Job title: Director, Pharmacokinetics, Dynamics, and Metabolism
- Location: - US / Cambridge (U.S.) / Cambridge Crossing
- 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 Director, Pharmacokinetics, Dynamics, and Metabolism! you’ll serve as a clinical PK/PD expert participating in multidisciplinary teams for clinical phase development projects in different therapeutic areas. This position will be based in Cambridge, MA.
The Pharmacokinetics, Dynamics, and Metabolism (PKDM) department at Sanofi contributes to the safe and effective therapeutic treatment of each patient by applying appropriate Model Informed Drug Development principles to support drug development and accelerating the process, where possible. PKDM generates, integrates, and leverages clinical and non-clinical PK, PK/PD, and metabolism knowledge to support critical decision making and risk management for projects from first in human dosing through life cycle management
Main Responsibilities:
- Formulate drug development questions and develop quantitative pharmacology strategies for programs in all stages of development, ranging from first in human dosing through life cycle management.
- Serve as a PKDM representative on project team(s) and works in close collaboration with multidisciplinary team to progress drug candidates from IND through early phase/late phase to successful approval.
- Responsible for the design, planning and oversight of relevant clinical studies, as well as PK/PD analysis, interpretation, and reporting of results for molecules/compounds in clinical stage.
- Apply quantitative skills, via modeling and simulation, to provide dose selection and complex issues at various stages of drug development.
- Responsible for clinical pharmacology contributions to regulatory documents and inquiries from regulatory agencies worldwide.
About You:
- Experience: Extensive experience in clinical development including PK/PD concepts and modeling & simulation strategies to support drug development.
- Demonstrated expertise in supporting development programs across various therapeutic areas.
- Demonstrated experience in interacting with and influencing regulatory agencies worldwide such as FDA, EMA and PMDA.
- Experience influencing and collaborating with cross-functional teams in a multicultural environment.
- Education: Ph.D. with or without post-doctoral experience plus at least twelve (12) years of relevant experience or;
- MS/MA degree in a Biological, Chemical, Mathematical, Computer Science or related discipline plus at least 16 years of relevant experience or;
- BS/BA degree in a Biological, Chemical, Mathematical, Computer Science or related discipline plus at least 18 years of relevant experience or;
- Equivalent theoretical and technical knowledge
- Soft and technical skills
- Effective communication and interpersonal skills with proven ability to engage key stakeholders.
- Strong track record with publications and external presence.
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.
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