Nuvisan

Lab Head (m/f/d) in vitro DMPK

Posted: 4 minutes ago

Job Description

We are seeking a hands-on, scientifically driven leader to head our pre-/non-clinical in vitro DMPK laboratory. You will oversee a team of 2-4 lab technicians, ensure high assay performance, introduce innovative methodologies, and serve as the DMPK representative in cross-functional drug discovery and development teams, The role combines operational lab leadership, scientific excellence, client interaction, and regulatory-quality documentation.Responsibilities Lead and develop a high-performing in vitro DMPK team (2-4 technicians); plan, coordinate and optimize day-to-day lab operations and resource allocationDesign, execute, troubleshoot, and report routine and advanced in vitro ADME/DMPK studies, including:Transporter assays (uptake/efflux, drug-drug interaction risk evaluation)Permeability and stability assessmentsProtein binding and whole blood distributionEnzyme phenotyping, CYP inhibition and inductionMicrosomal and hepatic clearance studiesEnsure high date quality and assay robustness across manual and automated workflows; drive continuous improvement of methodologies and SOPsEvaluate, implement, and validate new technologies to advance in vitro DMPK capabilities; champion workflow automation where impactfulIntegrate in vitro findings with in vivo PK data to inform project decisions; act as DMPK representative in cross-functional teamsAuthor, edit, and contribute to study reports and regulatory documents (e.g., Investigator's Brochure, IMPD, IND, CTD); maintain compliant quality documentation (SOPs, audit-ready records)Support client interactions: prepare and deliver presentations, host customer visits, and contribute to auditsContribute to budget planning at group project level, monitor spend against planEnsure compliance with apllicable regulations and guidelines (GxP principles, health and safety, environmental protection, radiation protection as applicable) and with EMA, FDA, and ICH guidance relevant to in vitro DMPK and drug-drug interaction evaluation QUALIFICATIONSPh.D. (or equivalent) in life sciences (chemistry, biochemistry, pharmacy) and postdoctoral experienceHands-on DMPK/ADME experience in pharma, biotech, or CRO environment, including leading small to mid-sized teamsDeep knowledge of drug metabolism, enzymology, absorption, distribution, and in vitro ADME development processesStrong understanding of R&D practices; familiarity with cellular/molecular biology and chemistry relevant to in vitro DMPKProven experience with quantitative bioanalytical methods (LC-MS/MS; HPLC with radio detection)Experience with PK/PD modeling and simulation tools (Phoenix WinNonlin, SimCYP, GastroPlus) is beneficial but not requiredThorough knowledge of international regulatory principles and health authority guidelines (EMA, FDA, ICH), particularly for in vitro DMPK and DDI evaluationExcellent communication and presentation skills; collaborative, self-driven, and results-oriented; adept at building relationships internally and externallyTrack record in authoring study reports and submission-relevant dossiersFluent German and English (written and spoken)WE OFFEROpportunity to shape and scale in vitro DMPK capability with tangible impact on discovery and development decisionsA collaborative, cross-functional environment with strong scientific standardsCompetitive compensation and benefits aligned with experience and responsibilityUnlimited contract, 30 days holiday per year, flexible working hours, including a modern workplaceCompany pension scheme and health prevention offersComprehensive introduction and individual training and developmentBVG job ticket and free parking spaces directly on-site

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