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Infectious disease-related research at OHSU is a highly collaborative effort that spans the entire University, including but not limited to the Division of Infectious Diseases, the Department of Molecular Microbiology and Immunology (MMI), the Vaccine and Gene Therapy Institute (VTGI), the School of Dentistry, and the School of Public Health.
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Experience with biosafety assessment of raw materials, viruses, and cell lines used for gene and cell therapy products, including preparation of regulatory filings and responses to questions from health authorities.
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Good understanding of oncology and immunology; experience in supporting cell therapy products through clinical development. Monitor changes and evolution in the regulatory landscape for relevant cell and gene therapy products and/or relevant product classes; analyze the impact of new regulations on assigned projects; participate in or propose initiatives to influence regulatory landscape.
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Articulate and communicate non-clinical safety strategies and provide development plans for multiple drug modalities including but not limited to small molecules, biologics, ADCs, and/or cell and gene therapies, across various therapeutic areas including but not limited to oncology, neuroscience, and immunology.
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Regeneron is seeking an Analytical Scientist specializing in Cell and Gene Therapy (CGT) programs. You must have a PhD in Molecular Biology, Chemistry, Biochemistry, Cell Biology, Virology, Immunology, or related field.
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About the role The Computational Biologist will work closely with scientists and other computational biologists to analyze NGS genomics data and develop bioinformatics methods to solve exciting and challenging problems in cell and gene therapy, immunology, and stem cell biology.
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SCiAN’s therapeutic expertise includes immuno-oncology, gene therapy, CNS, infectious disease, autoimmune diseases and diabetes. As Lead Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on any of the following: Immunology, Early Development, Medical Affairs, Oncology, and Infectious Disease studies.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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These instruments are critical tools in the research, development, and manufacturing for several key areas including Cell and Gene Therapy, Infectious Disease, Virology and Vaccine Research, Immunology, Immuno-oncology, and Immunotherapy, as well as Next Generation Sequencing, and Pre-Natal Disease Detection.
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In collaboration with UCSF Alpha Clinic and the Living Therapeutics Initiative, the program is committed to driving rapid innovations in academic cell and gene therapy development. In support of cellular and gene therapy programs at UCSF, manage the necessary documentation, submissions, and communications with the FDA for successful IND submissions and in support of clinical studies.
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Gene therapy experience would be considered as an advantage. Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for General Medicine: Gastrointestinal diseases (NASH, Ulcerative Colitis, Chrons Disease, Constipation, Inflammatory Bowel Disease); Immunology (Lupus, Rheumatoid Arthritis, Gout, Osteoarthritis); Dermatology (Atopic Dermatitis, Psoriasis); Womens health and Genitourinary.
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We require experienced CTMs with (Dermatology , GI, (UC/CD) Liver, Nephrology, Rare Disease, Diabetes, Obesity, Dyslipidemia) At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team.
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We are the people of PPD Clinical Research Services thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
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Clinical research experience in all phases of study life cycle, including start up, interim and close out. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
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We have a flexible working culture, where PPD truly value a work-life balance. Senior/Principal) Clinical Team Manager - General Medicine. This exciting and unique role could take you the next step of your career within Clinical Research.
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As a Senior Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. The position is opened in Bulgaria and Serbia for office or home-based employees.
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