NBE DMPK Project Representative all genders
NBE DMPK Project Representative all genders
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Job Description
Your Role: 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 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 DMPK strategy for each molecule including PK strategies to derisk the clinical development plan bioanalytical strategies both preclinically and clinically and immunogenicity risk assessments (IRAs) and for ensuring that studies are conducted on time and with the required quality. They 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 subteams. 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:
- PhD in biochemistry chemistry immunology or equivalent training with industry experience in pharmacokinetics NBE bioanalysis and immunogenicity preferred.
- Several years of professional experience in drug discovery/development >5 years) with excellent knowledge of drug development & discovery processes and workflows.
- 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 (nonclinical and clinical).
- General knowledge of NBE bioanalytics and related method of analyses handson experience is a plus.
- General knowledge of disease areas (e.g. Immunology Oncology etc. more indepth understanding of biology pharmacology.
- General understanding of modeling and simulation approaches for NBE bioanalytics and related method of analyses handson experience is a plus.
- Excellent organizational skills and communication skills; fluent spoken and written English German is a plus.
- Excellent intercultural understanding.
- Strong mature leadership and influencing skills.
Job Evaluation: Expert 3
Department:RDCXSBU NBE DMPK Project Representat.
Required Experience:
Unclear Seniority
Employment Type
Contract
