Principal Scientist, DMPK
Overview
A top pharmaceutical company out of the New York/New Jersey area is hiring for a Principal Scientist, DMPK. This company is leading biotechnology company that invents life-transforming medicines and has built a reputation in this space with multiple drugs on the market. This company has roughly 10 therapeutic specialties and multiple Phase I, II and III trials ongoing. This company is continuing to expand and requiring more support.
We are looking for a Senior Pharmokineticist who will provide oversight and input into overseeing and designing early preclinical and nonclinical in vivo studies. This individual will support Pharmacokinetic (PK) and Pharmacodynamic (PD) requirements for discovery and IND-stage project teams by designing summary reports and documents supporting regulatory findings. The PK/PD analyses are presented to senior management, internal project teams. This person will be expected to collaborate with therapeutic area staff and/or CRO’s performing the studies.
What would you be doing?
Conduct PK or PK/PD analyses using data derived from preclinical data
Contribute on discovery-stage project teams as a subject matter expert for the preclinical/PPK/PD group, providing PK and PK/PD input to the design of preclinical studies
Engage across various groups such as therapeutic proteins, therapeutic function areas, assay development, precision medicine, preclinical operations and PPK/PD management to develop PK strategy for designated projects
Communicate between project teams and management
Work closely with Toxicology, Pathology, Clinical Pharmacology and Quantitative Pharmacology within drug safety and pharmacometrics department to deliver data, reports and regulatory documents
Maintain updated knowledge of scientific literature as well as regulatory guidance and standards as they pertain to PPK/PD
Requirements:
Minimum PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, or Biochemistry
5-8 years relevant industry experience (Biotech or Pharma)
In-depth understanding (theoretical and applied) of PK and PD and be able to describe pharmacology/ biology of therapeutic proteins
Experience planning, organizing and overseeing PK or PK/PD studies and analyze PK/PD data
Experience leading a team
Excellent communication and presentation skills
Previous experience with protein/monoclonal antibody therapeutics in one or more of the following therapeutic areas – oncology, inflammation/immunology, metabolism, infectious disease or ophthalmology
Experience drafting PK reports and relevant IND sections
Experience with other modalities (siRNA, gene therapy, CAR-T, etc).