Lead DMPK Scientist

vor 4 Wochen

Grafing bei München, Bayern, Deutschland Nuvisan GmbH Vollzeit


Lead DMPK Scientist (f/m/d) at Nuvisan GmbH | softgarden

Lead DMPK Scientist (f/m/d)
  • Full-time
  • Remote
  • Grafing near Munich, Germany
  • With professional experience

We are seeking a dedicated and enthusiastic PhD-level researcher with extensive expertise in drug metabolism and pharmacokinetics (DMPK) to become a part of our team in Grafing (Germany) close to Munich. In your position within the Pharmacokinetic Sciences (PKS) group, you will deliver scientific contributions to drug discovery and/or development initiatives for our clients and develop internal modeling and simulation capabilities.

Your collaboration with operational DMPK teams in Grafing and other NUVISAN locations will be essential. If you possess exceptional scientific and organizational abilities and are fully committed to teamwork, this role presents an exciting opportunity for you.

KEY RESPONSIBILITIES

Providing DMPK consultancy for new chemical entities (NCEs) and/or other modalities, guiding pharmaceutical clients through various stages of the R&D value chain.

Evaluating PK/PD relationships in pre-clinical models and forecasting human PK parameters, dosage, and dosing schedules.

Offering scientific guidance for the design of in vitro and/or in vivo DMPK studies.

Conducting gap analyses of DMPK discovery and/or development packages.

Performing non-compartmental analyses (NCA) for PK and toxicokinetic studies.

Drafting DMPK sections of regulatory submissions (IND, IMPD) and Briefing Books.

Acting as the DMPK representative in client project teams, designing and overseeing PK experiments to support compound optimization, drug candidate selection, and/or subsequent development (collaborating with operational teams in Grafing and other locations).

Serving as project manager and primary client contact for phase projects (e.g., from candidate selection to First in Human trials), ensuring oversight of in vitro and in vivo DMPK, bioanalytical, and toxicokinetic studies conducted by NUVISAN.

Staying updated on literature related to DMPK and maintaining awareness of the latest advancements in the field.

Contributing to the strategic vision of the leadership team and supporting the expansion of NUVISAN's service offerings and capabilities.

QUALIFICATIONS

PhD in pharmacy, biochemistry, chemistry, or related disciplines with relevant DMPK experience in the pharmaceutical, biotech industry, or at CROs (minimum of 5 years).

In-depth understanding of the drug discovery and development process and the role of DMPK studies within it.

Experience in PK/PD modeling and simulation and familiarity with associated tools (Phoenix WinNonlin, SimCYP, or GastroPlus) is advantageous but not mandatory.

Outstanding interpersonal and communication skills with a strong focus on customer service.

Proficient in English, both written and spoken; knowledge of German is a plus.

Proactive problem-solving attitude and high personal initiative.

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