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Strong subject matter expertise in immune-oncology, cell therapy drug discovery and development including CMC considerations, CAR design, engineering and armoring strategies, innate immune cells such as NK and gamma delta for the purposes of leading drug development projects from start to the clinic.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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Responsibilities Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material. Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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Working knowledge of Drug Safety/Pharmacovigilance processes (Intake, Safety Case Processing, Expedited Reporting, Periodic Reports, and Document Management, Report Writing/Analytics) by leveraging any related software.
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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Drive cross-functional collaboration across our data science, machine learning, lab informatics, and medicinal chemistry teams to advance our computational infrastructure for our drug discovery and development mission.
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This position offers a unique opportunity to work in a dynamic and innovative environment developing your career at the interface of mechanistic research, drug discovery, and preclinical drug development.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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PhD in Toxicology, Biology, Pharmacology, or other relevant field with minimum 12 years of professional/industry experience in toxicology–related research and/or drug discovery and development.
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Experience in cancer biology, working in oncology drug discovery project teams, cancer cell-based assay design, assay development and drug testing. Contribute to target validation to ensure the development of a robust preclinical pipeline of impactful drug discovery programs.
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The Development Associate will support the fundraising and development operations of NEMPAC, including working in our donation client relationship management system, performing basic administrative duties, coordination and planning of corporate giving, and event fundraiser support and execution of online auction.
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This individual will have the opportunity to join a dynamic interdisciplinary team and also be part of the Flagship ecosystem of companies, providing unique networking benefits through regular meetups, collaboration, and an environment of development and discussion around new ideas shaping the fields of computational biology, ML/AI and data-driven drug discovery.
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Direct and working knowledge of Mobile Device Management (MDM) platforms (i.e., MaaS360, AirWatch/Workspace One, MobileIron, Meraki, Jamf, Intune/MSEM). Interface with the Microsoft Office 365 cloud with ActiveSync in the current AirWatch cloud and support the development of new MDM non AirWatch solutions.
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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As an Information Architect, you will deliver innovative data management, integration, and streaming platforms to underpin cutting-edge drug discovery processes. Your solutions will enable data analysis, machine learning and data driven decision-making by therapeutic project teams throughout the drug discovery and early development pipeline.
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management drug development jobs Title: vice president in Cambridge, MA
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