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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization.
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Abbvie is seeking a highly motivated and experienced translational scientist to lead a team of senior scientists accountable for driving the development, planning, and execution of the clinical translational research and precision medicine strategy across the rheumatology or gastroenterology drug pipeline at Abbvie.
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Work on issues related to Medicare coverage determinations, Medicaid coverage and preferred drug list determinations, FDA drug development and safety policies, agency guidance policies related to patient engagement and diversity equity and inclusion (DEI) impacting health access, clinical trials, and research opportunities.
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Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
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Essential Functions Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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You will focus on projects from the start of assay development to clinical trial implementation as well as data management to ensure we are obtaining high-quality data from our clinical trials.
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The individual will lead the management of manufacturing of established drug substance for late-phase clinical trials and the development of new products. The individual will also contribute to the overall CMC strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in CDMO management for other CMC areas including analytical and drug product.
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Successful candidates will demonstrate potential to develop a prominent and innovative research program that complements the University's research strengths in host-pathogen interactions, immunity and host defense, virology, mycology, genomics, drug discovery, translational research, and clinical trials.
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Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
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Knowledge & Other Requirements Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development.
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We are using models early to fail less often, executing clinical trials to add valuation to the company, and generating fit-for-purpose data to feed back into Valo’s Opal Computational Platform as we reinvent drug discovery and development from the ground up.
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Work with our AI/ML platform and Biologists to support efforts in Drug Discovery and Translational Biology, including demonstrating mechanisms of action then used to develop a biomarker and patient preselection strategy to aid clinical development.
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The candidate will have a strong publication record demonstrating relevant experience in clinical trials, translational medicine/research, early drug development, drug discovery and/or biomarkers.
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Children’s GMP supports clinical trials on campus at St. Jude through manufacture of biological drug products – these include viral vectors, monoclonal antibodies, and cellular therapy products.
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