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A bachelor's degree in a relevant field is required as a strong scientific foundation (e.g. molecular biology, engineering, biochemistry, pharmacology) is required for the position. Our client is a privately-owned contract development and manufacturing organization (CDMO) focused on helping clients from pre-clinical to development and commercialization of biologics, medical devices, and combination drugs.
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Demonstrated expertise and knowledge in the drug discovery/development and manufacturing market (cell, gene therapy or, large molecules or, biologics) with understanding of the served and total markets available.
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Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields. development/support, scientific affairs, operations, or related area.
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A minimum of 10 years of related pharmaceutical or biotechnology industry experience in clinical pharmacology, population PK, PK-PD modeling, DMPK, and/or pharmacometrics and a proven track record advancing programs through the drug development process, from discovery through IND to registration, informing data driven decisions on dose and schedule, making tough judgement calls where needed.
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Within Janssen R&D, the Therapeutics Discovery organization is continuing to build the key scientific expertise to bring ground-breaking new medicines to patients; we invest in medicinal chemistry, screening, and pharmacology, and in the computational and data science fields that inspire and inform them.
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Represent the clinical pharmacology department as subject matter expert on development teams and at governance board meetings. Collaborate with the clinical development teams and/or clinical study teams to optimize patient trial design and execution, explore exposure-response relationships for safety and efficacy, and deliver NDA enabling clinical pharmacology studies.
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You will be responsible for oversight and interaction with consultants and CROs assigned to support clinical pharmacology tasks including preclinical PK, modeling, and clinical assay development.
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Lead internal target selection, and validation (including assay development, compound screening, in vitro and in vivo pharmacology including in vivo PK/PD/efficacy models as well as additional studies (including toxicity) required to declare a compelling clinical candidate.
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Build QSP models integrating biological, pharmacological, and physiological data to support drug development at all stages, from preclinical research to clinical trials and beyond, aiding in dose optimization, biomarker identification, safety and efficacy assessment, drug development decision-making, etc.
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The ECS Clinician will work with other functional disciplines as needed (e.g. Research Unit clinicians/Global Clinical Leads/Medical Monitors, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine.
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The Senior Scientist, Toxicologist will partner with the Vice President of Toxicology to develop and carry out the overall toxicology strategy for programs in both Discovery and Development. The Toxicologist will collaborate with external vendors, the internal preclinical pharmacology and toxicology team, and other stakeholders across the company to ensure efficient processes that scale with Verve's continued growth.
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Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies.
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Performs any combination of sample management tasks, including labeling, aliquoting, ordering tests, inventory control and disposing of samples after defined retention policy. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
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We are currently seeking a Board-Certified Ophthalmologist to add to our professional consulting staff. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
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