Senior DMPK Expert

Vor 6 Tagen

Grafing bei München, Bayern, Deutschland Nuvisan GmbH Vollzeit
Job Description

We are seeking a highly motivated and passionate PhD-level scientist with extensive experience in drug metabolism and pharmacokinetics (DMPK) to join our team at Nuvisan GmbH. As a Senior DMPK Expert, you will provide scientific input into drug discovery and/or development programs of our clients and establish internal modeling and simulation capabilities.

You will work closely together with operational DMPK teams to provide DMPK consultancy for new chemical entities (NCEs) and/or other modalities, guiding pharmaceutical clients throughout different phases of the R&D value chain.

Key Responsibilities
  • Assessing PK/PD relationships in pre-clinical models, and predicting human PK parameters, dose, and dosing regimens.
  • Providing scientific input to the design of in vitro and/or in vivo DMPK studies.
  • Performing gap analyses of DMPK discovery and/or development packages.
  • Conducting non-compartmental analyses (NCA) for PK and toxicokinetic studies.
  • Writing DMPK sections of regulatory dossiers (IND, IMPD) and Briefing Books.
  • Acting as DMPK representative in client's project teams, designing and commissioning PK experiments to support compound optimization, drug candidate selection, and/or subsequent development.
  • Acting as project manager and client's contact for phase projects, comprising oversight of in vitro and in vivo DMPK, bioanalytical, and toxicokinetic studies performed by Nuvisan.
  • Following literature related to DMPK and maintaining awareness of the latest developments in that area.
  • Supporting the strategic vision of the leadership team as well as the expansion of Nuvisan's service portfolio and capabilities.
Requirements
  • PhD in pharmacy, biochemistry, chemistry, or related fields with relevant DMPK experience in the pharmaceutical, biotech industry, or at CROs (at least 5 years).
  • Profound knowledge of the drug discovery and development process and how DMPK studies contribute to that.
  • Experience in PK/PD modeling and simulation and use of associated tools (Phoenix WinNonlin, SimCYP, or GastroPlus) is not required, but beneficial.
  • Excellent interpersonal and communication skills and a strong customer focus.
  • Very good English language skills, both written and spoken, German is a plus.
  • Problem-solving attitude and high personal initiative.

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