Job description
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 team work, this position is an exciting opportunity for you.
RESPONSIBILITIES
Providing PK consultancy and guiding pharmaceutical clients throughout different phases of the R&D value chain
Supporting the generation of development plans for new chemical entities (NCEs) and other modalities such as Antibody Drug Conjugates (ADCs) or PROTACs
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
Writing DMPK sections of regulatory dossiers (IND, IMPD) and Briefing Books
Conducting non-compartmental analyses (NCA) for PK and toxicokinetic studies
Establishing internal PK/PD modeling and simulation capabilities, exploring the PK/PD relationship 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
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
Proficient in Phoenix WinNonlin and ideally experienced with simulation software/tools such as SimCYP or GastroPlus)
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
MUST HAVE
If you are someone who wants to influence your own development and you are looking for a position where you have the opportunity to pursue your interests across all DMPK aspects, where you can provide services and impact our client drug development plans and build develop our high quality DMPK services further.
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