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The candidate should have commensurate experience in the biotechnology industry to understand both pre-clinical / IND and clinical drug development process in biologics or gene therapy, and be skilled in the use of Project Management tools such as Smartsheet, SharePoint sites, etc.
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For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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Maplewood Senior Living conducts pre-employment screening including background check, drug screening and reference checks. Supports the Director of Nursing (Resident Services Director) in the administration of the nursing services.
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Drive planning for key drug development stage-gate decision points after Phase 1 and co-chair stage-gate committee for Rare Disease franchise. Successful candidate will have a strong understanding of the drug development process from preclinical pharmacology through to regulatory approval and the principles, concepts, practices, and standards of pharmaceutical program management.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Sr. Director of Drug Safety Risk Management. Prior experience in drug safety and risk management is strongly preferred. Support regulatory submissions, including applications for marketing authorization and new drug/biologic licenses.
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In this role, Medical Director helps develop multiple products within the liver disease team working with MASH and ALD projects covering clinical drug development from preclinical assessment through Phase 1-4.
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PCO is looking for a Scientific Associate Director to join the Dev DMPK group that is an expert in ADME and pharmaceutical drug development of protein therapeutics and small molecule drugs.
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Qualifications MD or the international equivalent is required 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background Working knowledge of the drug development process required.
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Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.· Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
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A comprehensive grasp of the drug development process, particularly in the context of RWLP study. Strong knowledge of global regulatory principles and practices across the drug development.
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A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
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Associate Director, Biologics Drug Product Development oversees the formulation development and fill finish processes for bio-therapeutics, technology transfer to clinical and commercial CDMOs∯*∯ You should have extensive experience in early and late phase Biologics development and foster productive collaborations with internal QA, Clinical Development and Regulatory teams.
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Maintains expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
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Equal Opportunity Employer (EOE), Minority/Female/Disabled/Veteran (M/F/D/V), and Drug Free Workplace (DFW). As the Assistant Plaza Director, you will assist the Plaza Director in managing the overall day-to-day operations and long-term profitability of a multi-million-dollar travel plaza located along a major highway.
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drug job Title: director in Monmouth Junction, NJ
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