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Director DMPK and Bioanalytics (m/f/d)
Aktualität: 14.09.2023


14.09.2023, Tubulis GmbH
Director DMPK and Bioanalytics (m/f/d)
The Director DMPK and Bioanalytics will be part of an agile and highly efficient integrated R&D team being responsible for managing and overseeing all bioanalytical and DMPK activities for Tubulis' innovative ADC candidates. The incumbent will work closely with the research, preclinical and clinical organization as well as with CROs and consultants. Therefore, you must be highly adept at building and managing relationships across various functions, and positioning results with a deep scientific understanding as to how the findings relate to early lead selection through development. Responsible for development, transfer and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of candidate ADCs and any concomitant/interaction compound in the given project to support non-clinical and clinical studies Lead DMPK and bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs Technical monitoring during bioanalytical method development, validation, and sample analysis Outsourcing and managing activities in DMPK and Bioanalytics (from proposal generation to report approval); resource and time planning, coordination and administrative management of studies with CROs Ensure validity, accuracy, relevance and completeness of scientific content in non-GLP and GLP non-clinical research and regulatory documents Ensure full compliance with the current global and local bioanalytical guidelines and GxPs Responsible for original writing, editing and review of documents or regulatory submission May represent the company as DMPK & Bioanalytical representative at meetings with regulatory bodie Attend appropriate scientific meetings and stay up to date with relevant scientific literature to maintain expertise Accountable for incorporating relevant recent advances in the field into non-clinical research
Ph.D. in Pharmacokinetics, Drug Metabolism, Biochemistry, or equivalent and a minimum of 5 years of relevant industry experience Knowledge of DMPK science inside a complex research and development setting in a biotech organization or pharmaceutical company Broad knowledge across pharmacokinetics, pharmacodynamics, ADME, and bioanalytics In depth knowledge in bioanalytical assay development to support non-clinical and clinical studies In depth understanding of the drug development process and of non-clinical development. Experience with ADCs is a plus Strong ability to manage multiple studies simultaneously and to be able to assist in troubleshooting when instrument or assay problems arise Experienced in authoring and providing regulatory guidance to team members on technical reports/suitable for inclusion in registration dossiers Familiar with ICH, FDA and other regulatory guidance and regulations relevant to non-clinical research Excellent communication skills and proven ability to collaborate with interdisciplinary teams and CROs. German is a plus Excellent managerial and leadership skills. Must be highly organized and extremely analytical with strong problem-solving skills Ability to align activities with company objectives Able to work independently and work well in a team and in a fast-paced environment



Director DMPK and Bioanalytics (m­­/­­f­­/­­d)