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The successful candidate will lead and oversee formulation-drug product process development, tech transfer, and manufacturing with external development and manufacturing partners; in addition to leveraging Cerevel's internal formulation development capabilities as well as a growing array of analytical and physical characterization instruments.
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Deep understanding of the pre-clinical, translational, and clinical stages of drug development. Extensive working knowledge of biomarker and bioanalytical assay development and cutting-edge Omics methodologies in the clinic.
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Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
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Knowledge of drug development process, pharmacovigilance databases and MedDRA coding. Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 10-12+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.
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Characterization and development of stable solid-state and/or suspension drug products, preferably protein therapeutics. Strong grasp of pharmacological concepts and a fundamental understanding of drug product development.
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Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace.
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Broad and deep understanding of the drug development process and associated operational experience, advanced knowledge of regulatory and business requirements. Ideally additional experience in a regulatory, translational medicine, clinical science, DMPK or other drug discovery roles.
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International Oncology Medical Affairs, Pfizer Research & Development (PRD) cross-TA global Medical platforms, Worldwide Medical, Drug Safety Research and Development and Safety in order to drive TA Medical Strategy across the organization.
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Synthetic Molecule Design and Development (SMDD) has an exciting opportunity for a synthetic research scientist to join our interdisciplinary team of analytical chemists, engineers, pharmaceutical scientists, and process chemists with primary focus on emerging novel modalities including oligonucleotide drug substance process chemistry.
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Our client offers preclinical services for drug discovery, focused on the use of nonhuman primates to determine pharmacokinetics, pharmacology and toxicology of small molecules and biologics. Job Title: Business Development Director.
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This role is responsible for identifying, developing, and implementing global and regional neuromuscular and disease-specific market access initiatives aligned with Dyne’s drug development objectives.
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Has managed drug safety through all Phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds' and product recalls/withdrawals, and safety-related label changes.
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Keep abreast of emerging developments regarding research and development in the fields of muscle diseases and oligonucleotide drug discovery and development. Experience in Phase 1-3 drug development is required; product launch/early commercialization experience a strong plus.
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PhD or equivalent in biological sciences with significant experience advancing gene therapy-focused drug discovery projects into development in a pharmaceutical or biotech environment. Provide scientific leadership, expertise, and management from discovery through translational activities with a focus onidentifying drug targets and high-priority disease indications,progressing assets into the clinic, interrogating and elucidating mechanism of action, identifying appropriate disease models, conducting pharmacology studies, and rapidly progressing therapeutic programs forward through R&D.
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Strong knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China.
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drug development jobs in Cambridge, MA
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