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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes.
$145,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Participate in senior level scientific, strategic, and operational aspects of drug development within the pharmacology, toxicology, and early stage clinical drug development process.
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Director for Downstream Process Development, you will develop, design and transfer downstream processes for a variety of product candidates spanning early and late stage development and multiple modalities (including complex Fc fusion proteins, mAbs and mRNA) at Shattuck Labs. You will lead the downstream process development team and coordinate efforts with multiple teams across R&D and Technical Operations to deliver downstream processes for our pipeline of drug candidates.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience working with other functions including preclinical and late-stage clinical development and external collaborators. Experience in oncology drug development and regulatory sciences with early clinical programs through regulatory interactions, including FIH studies and IND.
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This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.
$160,000 - $210,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Our client is a clinical-stage biopharma company developing precision oncology medicines using its proprietary proteomics platform to develop drug-specific companion diagnostics. Responsible for training activities (including curriculum development) and SOP generation.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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They will also be a member of the Pivotal/Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Sciences, MSAT, and Materials Sciences.
$274,635 - $355,410 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Strong background in strategy development Background in tumor genomics and/or single cell analysis Understanding of late-stage drug and translational development process Proven ability to work with global disease teams to develop strategies to support life cycle management efforts tailored to regional markets (i.
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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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Participate in process development activities for commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and ongoing commercial manufacturing.
$124,000 - $138,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Strong background mid- and late-stage drug development that includes familiarity with multiple therapeutic areas, regulatory operations, observational studies, biostatistics and medical operations.
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In this highly matrixed role, they will independently design, develop, communicate at senior levels and oversee implementation of clinical biomarker strategies to support key programs in early and late stage drug development.
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Key Qualifications Experience leading clinical trial operations as an Associate Director, Director or Senior Director level role including multinational/multisite clinical studies with experience in rare diseases, immunology, neurology, and/or ophthalmology drug development.
ExpandApply NowActive JobUpdated 8 days ago
drug development stage jobs
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