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Our Client's global life sciences practice, one of the largest in the U.S., is seeking a regulatory counsel with at least 10+ years of industry experience in drug/biologics development to join our FDA regulatory group.
$150ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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Strengthen internal gene therapy CMC capability and serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at Adverum for its development programs.
$250Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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As a DMPK project representative a candidate will lead the DMPK strategy for programs at various stages of drug discovery/development in collaboration with an inter-disciplinary team.
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We seek an individual with strong leadership skills, expert therapeutic area knowledge, advanced understanding of the regulations governing drug development and the application of Quality Risk Management principles.
$237,660 - $307,560ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Direct experience with immuno-oncology drug development and checkpoint inhibitors highly preferred. Direct experience with oncology drug development highly preferred. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.
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Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
$175,000 - $230,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The ideal individual for this role should have established relationships with federal officials, legislators, and regulators who make public policy decisions so that BridgeBio can have a voice in important policy discussions and decisions that impact drug development, innovation, and access to treatments.
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Partner with cross-functional program team members and key R&D stakeholders to contribute to the clinical strategy and creation of clinical development plans for one or more candidate clinical drug products.
$190,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Per the integrated CMC strategy, the candidate will represent Process Development in support of regulatory filing, clinical manufacturing, raw materials and logistics, and interface with ClinOps for drug product administration conditions.
$150Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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This role requires collaboration with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle.
$115,260 - $149,160 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Support the development of global brand strategy, identifying opportunities and critical issues that can impact pipeline assets. Understanding of the drug development process, especially regarding opportunities for differentiation and value demonstration.
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A minimum of 8 years in roles of increasingly responsible in regulatory affairs or related areas in pharmaceutical drug development. An Associate Director, Regulatory Affairs within the Regulatory Strategy group will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products.
$152,000 - $228,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Seeking an entrepreneurial, strategic, driven, and visionary scientific leader to join our team as VP, Biology and Translational Research reporting to EVP, Chief Drug Discovery and Pre-clinical Development Officer.
$310,000 - $335,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate. Works collaboratively with Clinical Operation, Data Management,Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
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drug development strategy jobs in Palo Alto, CA
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