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The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development.
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As an Analytical Development Scientist, you will play a critical role in supporting the development and transfer of analytical methods for biologic drugs, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs.
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This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.
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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
$114,375 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements. Familiarity with EMA and FDA regulatory requirements for process development submissions. This position involves close collaboration within MST, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups.
$157,100 - $217,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management.
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The Pharmacokinetics, Dynamics, and Metabolism (PKDM) department at Sanofi contributes to the safe and effective therapeutic treatment of each patient by applying appropriate pharmacokinetic (PK) and pharmacodynamic (PD) principles to drug development and accelerating the process, where possible.
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Qualifications & Experience:MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Perform routine analytical tests (e.g., SEC, CE, ICIEF, Protein A) to support the upstream and downstream process development. Proficient in analytical chemistry or biology background, skilled in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) analysis methods, including but not limited to HPLC, UPLC, CE, Elisa.
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MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly desired. Minimum of 10 years drug development/FDA/regulatory related industry experience required.
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Proficiency in analytical chemistry or biology with a strong background in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) using techniques such as HPLC, UPLC, CE, and Elisa.
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Job Title: Analyst, Analytical Development. Department: Analytical Development. Support the development and transfer of analytical methods of biologics drugs (including monoclonal antibodies, bispecific antibodies, Client.
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Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
$186,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Targeting 10 years of experience as lead statistician on clinical trials in the pharmaceutical industry with significant experience in rare disease drug development. Maintain thorough understanding of current regulatory guidelines and requirements relevant to rare disease drug development.
$200Full-timeExpandApply NowActive JobUpdated 2 days ago
drug development jobs Title: director safety in Montgomery, NJ
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