Associate Director Pharmacology

4 weeks ago

Cambridge, United States Greenfield Source Full time

This is an Associate Director level Pharmacokinetics, Dynamics, and Metabolism (PKDM) role. This department contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to 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. As such, we aid in dose selection/study design, de-risking of drug-drug interactions, benefit/risk assessment, and formulation development, with the use of Population PK, PK/PD, and PBPK approaches as appropriate, and contribute to regulatory submissions/interactions.


Job Summary:


PKDM at the company is seeking a dynamic individual to serve as a PK/PD expert participating in multidisciplinary teams for clinical phase development projects in different therapeutic areas. This position will be based in Cambridge, MA.


Serves 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 studies, as well as PK/PD analysis, interpretation, and reporting of results for molecules/compounds in clinical stage.


Applies 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.


Interfaces with Research and works closely with discovery research during the pre-IND stages of drug development to ensure sufficient PK/PD knowledge exists for translation to the clinic.


Basic Qualifications


5 relevant pharmaceutical PK/PD industry experience; demonstrates a sound knowledge of clinical pharmacology and PK/PD principles.


Possess strong knowledge of FIH study design


Proficient in PK modeling software/platforms.


Effective communication and interpersonal skills.


Strong presentation skills; good team player.


Education


Ph.D. degree in clinical pharmacology, pharmacokinetics, pharmacometrics, mathematics, engineering, computational biology or a related field required, with or without post-doctoral experience plus 5 years of relevant experience


MS/MA degree in clinical pharmacology, pharmacokinetics, pharmacometrics, mathematics, engineering, computational biology or a related field required plus at least 12 years of relevant experience

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