Senior DMPK Expert

Nuvisan

Grafing, Germany

We are looking for a highly motivated and passionate PhD-level scientist with very good experience in drug metabolism and pharmacokinetics (DMPK) to join our team in Grafing (Germany) near Munich. In your role within the Pharmacokinetic Sciences (PKS) group, 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 in Grafing and at other sites of NUVISAN. If you are someone with excellent scientific, organizational skills, and if you are fully committed to teamwork, this position is an exciting opportunity for you.

RESPONSIBILITIES

Providing DMPK consultancy for new chemical entities (NCEs) and/or other modalities and guiding pharmaceutical clients throughout different phases of the R&D value chain;
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 (interface to operational teams in Grafing and at other sites);
Acting as project manager and client’s contact for phase projects (e.g., from candidate selection to First in Human trials), 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.

QUALIFICATIONS

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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