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As a Digital Biomarker Lead you will be overseeing aspect of sensor-related research, from benchtop experiments to oversight of technical validation in large-scale clinical trials. This innovative position bridges the gap between traditional biomarkers and cutting-edge digital technologies, driving the development and validation of novel digital endpoints for clinical trials.
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Description The Department of Pediatrics at the Dell Medical School (DMS) at The University of Texas at Austin, along with its clinical partner Dell Children’s Medical Center, a part of the Ascension Seton Healthcare Family, is seeking a Program Director of Pediatric Stem Cell Transplantation and Cellular Therapy.
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The MEL conducts critical activities that support advancing science, educating on evolving clinical practices, transforming science into patient care, and facilitating the development of new research collaborations (including Investigator Initiated Trials and Real-World Evidence.
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The Senior Advisor/Director in Global Regulatory Affairs – CMC will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides.
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At least ten years of clinical research and/or clinical project management experience in global clinical trials (experience with early development oncology - i.e., Phase 1 oncology and/or hematology trials is strongly preferred.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE.
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This individual will play a crucial role in ensuring the successful execution of clinical trials and programs in the field of gene therapy, as well as fostering strong relationships with internal and external stakeholders.
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Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials. Proclinical Staffing is seeking a Senior Director, Clinical Biomarkers to join an innovative biotech company.
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Senior Director, Clinical Biomarkers - Permanent - Remote. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development. Develop strategic plans to meet budgetary requirements and successfully integrate companion diagnostic assays into end-of-life trials.
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Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance. Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development.
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Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies.
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Education: PhD degree in Biology, Translational Medicine, or related life sciences areas. Skills: Fluent in both verbal and written communication in Chinese and English. Manage study budgets and financial transactions with vendors, ensuring effective resource allocation and cost management.
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This is a permanent role with the opportunity to work remotely. Collaborate closely with internal and external teams to ensure timely project delivery and alignment with objectives. Work Experience: Minimum 5 years in translational medicine; 10 years preferred.
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If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com. Proclinical Staffing is an equal opportunity employer.
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Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.
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