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The RWE, Patient Advocacy and External Collaboration team fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed market (IDM) and emerging markets (EM) into one team to drive efficiency through internalized work while building processes to insure representation from multiple stakeholders, particularly patients.
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The incumbent will be responsible for establishing and maintaining a solid understanding of current industry trends with ADC payload linker and conjugation technologies, support due diligence projects for antibody-drug conjugates (ADCs) assets, interacting with internal and/or external research and development groups to support pre-clinical study material generation, and support clinical phase conjugation process development and technology transfer activities as needed.
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Knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of regulations, ICH/GCP, adverse event management.
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Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required. Provides regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.
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Leads design, implementation and interpretation of the global clinical program for a drug candidate to deliver a successful regulatory submission worldwide through regulatory submission and approval (i.e., Phase 2, 3, pediatric and interventional Phase 4 studies)Works closely with early development to ensure alignment between early and late stage development strategy.
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Create clinical development strategies and delivery plans for investigational and marketed products according to the Therapeutic Area- and global Product strategy. Could you be our next Senior Director of Clinical Research and Development.
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Experience in one or more of these areas: market access, pricing/reimbursement, health policy and/or health economics, sales, and marketing (or equivalent roles), market research.
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Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
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The Associate Director, Regulatory Affairs will be responsible for the development, implementation, and maintenance of North America regulatory strategies for compounds in the Immunology Therapeutic Area.
Full-timeExpandApply NowActive JobUpdated 18 days ago
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