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NBE DMPK Project Representative (all genders)
A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
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 de-risk 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 (non-clinical and clinical).
- General knowledge of NBE bioanalytics and related method of analyses, hands-on experience is a plus.
- General knowledge of disease areas (e.g. Immunology, Oncology, etc.), more in-depth understanding of biology, pharmacology.
- General understanding of modeling and simulation approaches for NBE bioanalytics and related method of analyses, hands-on experience is a plus.
- Excellent organizational skills and communication skills; fluent spoken and written English, German is a plus.
- Excellent inter-cultural understanding.
- Strong mature leadership and influencing skills.
Job Evaluation: Expert 3
Department: RD-CXSB-U NBE DMPK Project Representat.
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