Senior DMPK Scientist

vor 2 Wochen

Grafing bei München, Bayern, Deutschland Nuvisan GmbH Vollzeit

Nuvisan GmbH seeks a highly motivated and experienced Senior DMPK Scientist to contribute to our growing team of experts in Grafing, Germany.

In this role, you will provide critical scientific guidance throughout the drug discovery and development process for our clients. Your expertise in drug metabolism and pharmacokinetics (DMPK) will be instrumental in shaping successful pharmaceutical programs.

Responsibilities
  • Provide expert DMPK consultancy to pharmaceutical clients across various stages of the R&D lifecycle, from early discovery to clinical trials.
  • Assess PK/PD relationships in pre-clinical models and predict human pharmacokinetic parameters, optimal dosing regimens, and drug exposure profiles.
  • Contribute scientific insights to the design and execution of in vitro and in vivo DMPK studies, ensuring robust data generation for informed decision-making.
  • Conduct comprehensive gap analyses of existing DMPK data packages, identifying areas for improvement and strategic recommendations.
  • Perform non-compartmental analysis (NCA) on PK and toxicokinetic study data, generating clear and concise reports to support regulatory submissions.
  • Author high-quality DMPK sections for regulatory documents such as INDs, IMPDs, and Briefing Books, ensuring compliance with relevant guidelines.
  • Collaborate effectively with operational DMPK teams across Nuvisan sites, fostering a cohesive and efficient workflow.
  • Act as the primary DMPK point of contact for clients, managing project timelines, deliverables, and communication throughout the development process.
  • Stay abreast of the latest advancements in DMPK research and contribute to the expansion of Nuvisan's service offerings.
Qualifications
  • PhD in Pharmacy, Biochemistry, Chemistry, or a related field with a minimum of 5 years of relevant experience in the pharmaceutical industry, biotech sector, or CRO environment.
  • In-depth understanding of the drug discovery and development process, with a strong focus on the role of DMPK studies in guiding decision-making.
  • Experience with PK/PD modeling and simulation software (Phoenix WinNonlin, SimCYP, GastroPlus) is highly desirable but not mandatory.
  • Excellent communication, interpersonal skills, and a customer-centric approach are essential for success in this role.
  • Proficiency in English, both written and spoken, is required. German language skills are an asset.

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