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Director Biomarker Development (m/f/d)
Aktualität: 14.09.2023


14.09.2023, Tubulis GmbH
Director Biomarker Development (m/f/d)
The Director of Biomarker Development will lead the identification and implementation of appropriate biomarker strategies for Tubulis' innovative ADC programs. Together with colleagues from research, non-clinical and clinical development as well as with external experts, the incumbent will develop and execute biomarker candidate identification, assay development, validation and testing. Applicants should be able to serve an important role integrating biomarker efforts across our research, clinical and data science teams to support our drug discovery and development efforts. Provide scientific leadership in areas of biomarker discovery and development for ADC candidates Oversee development of translational and exploratory biomarker strategies to assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, patient selection and generate an understanding of the variability in patient response Support scientific input and review of all translational medicine aspects of clinical and regulatory documents, including but not limited to development plans, study protocols, clinical study reports, regulatory submissions and responses to any regulatory questions, etc Work independently and also in a cross-team environment with minimal guidance in defining, revising and progressing translational/biomarker plans for ADCs Utilize human and animal model data to support mechanism of action/validation studies for both non-clinical and clinical-stage ADCs drug candidates Ensure full compliance with the current global and local regulatory guidelines and GxPs Propose and develop innovative methods and technologies as well as new directions for project development Function as a scientific and business thought leader inside and outside of the company and a key link to external scientific & medical community
PhD (and/or MD) with experience in either Cellular or Molecular Biology, Cancer Biology and/or Pharmacology with at least 5 years of pharmaceutical or biotechnology industry experience in biomarker discovery and development Thorough understanding of clinical trials and clinical strategy, experience with oncology drug development as well as analytical and clinical validation of biomarker assays Experience with identification and validation of pharmacodynamic and patient selection biomarkers and clinical implementation Expertise in establishing and running preclinical studies Experienced in authoring and providing regulatory guidance to team members on technical reports/summaries, suitable for inclusion in registration dossiers In depth understanding of the drug development process and of non-clinical development. Experience with ADCs is a plus Familiar with ICH, FDA and other regulatory guidance and regulations relevant to biomarker development 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 Able to work independently and work well in a team and in a fast-paced environment



Director Biomarker Development (m­­/­­f­­/­­d)