Work Location: 45A Middlesex Turnpike Billerica, Massachusetts
Shift: no shift
Department: RD-XMA-U NBE DMPK Project Representative
This information is for internals only. Please do not share outside of the organization.
Project Representative, New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) is a strategic, scientific and operational role within Discovery Development and Technologies (DDTech) in Research and Development (R&D). The successful candidate will be responsible for managing the overall nonclinical DMPK contributions to NBE projects, from lead optimization through Life Cycle Management
(LCM), thus fulfilling internal and regulatory requirements.
The incumbent is responsible for defining the appropriate project plan, including bioanalytical strategies and immunogenicity risk assessments (IRAs), and for ensuring that studies are conducted on time and with the required quality. The selected candidate must also be able to qualitatively integrate the various bioanalytical and immunogenicity data to interpret the drug disposition of the NBE and to continuously update the bioanalytical strategies and IRAs as needed for assigned projects.
The NBE DMPK project representative also takes the role as member of the Discovery or Global Project Team (DPT or GPT), depending on the phase of the project, and as scientific matter expert on sub teams. Represents the DMPK function on these teams and ensures that the proper flow of information between the project, the function, and key stakeholders is in place.
Ensures that studies within DMPK responsibility of the given project are conducted according to the agreed timelines and the required quality depending on the stage of the projects. Provides PK assessments for preclinical studies and supports study monitors for outsourced preclinical and clinical studies to ensure high quality data, and that reports meet applicable international regulatory
requirements as well as project timelines.
Who you are:
Bachelor’s degree with 8 plus years, master’s degree with 3 plus years, or PhD degree.
- Advance degree in Pharmacokinetic or NBE bioanalysis, immunogenicity, or chemical-biological
- fields or equivalent training.
- 5 plus years of professional experience in drug discovery/development
- Excellent knowledge of drug development & discovery processes.
- Working experience in GxP regulated environment.
- Excellent knowledge of immunogenicity, DMPK, and related sciences.
- Solid understanding of translational sciences, regulatory requirements and NBE work packages
- (non-clinical and clinical).
- General knowledge of NBE bioanalytics and related method of analyses, hands-on experience is a plus.
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