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Design, develop, and execute complex in vitro experiments to identify and characterize small molecule antiviral inhibitors Form detailed observations, analyze data, and interpret results independently Participate in cross functional drug discovery teams by presenting and discussing experimental results Collaborate with colleagues in other functional groups to support all stages of drug discovery a
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Design and implement innovative solutions for development of complement factor proteins to address key challenges and support project deliverables on accelerated timelines Create, oversee, interpret, and present results from studies that influence the direction of CMC development strategies and activities Collaborate with internal/external stakeholders to develop and implement CMC plans, support p
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Manage relationships with Drug Substance CMOs, CROs, and key suppliers including coordination, communication, technical oversight, and ensuring timely delivery of cGMP products to support clinical trials Serve as primary technical and operational point of contact to support batch manufacture and testing, deviation investigation, batch review, and release of GMP material Collaborate with internal/e
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Conduct biological research to identify and develop new small molecule drugs for the treatment of infectious diseases Participate and contribute to the research strategy on target selection, validation, and screening approaches Provide strategic leadership and technical expertise in the functional area of biology and virology Lead and participate in cross functional drug discovery teams Support al
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Implement and oversee biological research to drive the discovery of new small molecule drugs Aid in research strategies on target selection, validation, and screening approaches Participate in and/or lead cross functional drug discovery teams Manage junior Biologists and provide guidance/training across the department Interpret and present complex data sets Support all stages of drug discovery and
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Execute virology and cell based assays to evaluate therapeutic agents Support the development of methods in anti viral research Troubleshoot challenging methodologies with minimal supervision Provide cross functional support to other projects, as needed Perform routine laboratory maintenance operations Communicate scientific data within the team EXPERIENCE Minimum of 2 years of relevant industry e
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Partner with the Senior Vice President, Pharmaceutical Development and Manufacturing to plan and prioritize CMC activities across the clinical portfolio Develop and maintain integrated CMC project plans and timelines for all clinical assets Verify that plans incorporate cross functional input Lead CMC cross functional and department team meetings to develop strategy and monitor progress Create age
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Interface by phone and in person with children and families Express sensitivity to patients and family members Ensure subject study records and site regulatory records are up to date, complete, and accurate EXPERIENCE Minimum of 5 years of clinically related experience required Minimum of 2 years of conducting clinical research for a commercially sponsored clinical trial Minimum of 2 years of expe
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Author updates and/or new departmental SOPs and Work Instructions Perform review of cross functional SOPs and Work Instructions on behalf of Clinical Operations Support inspection readiness Engage with a variety of cross departmental staff to conduct Gap analysis Ensure appropriate compliance with plans and procedures Lead and track Quarterly Operational Reviews Identify and mitigate risk through
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Determine necessary project resources Track and monitor progress and key metrics Communicate progress reports and results to stakeholders Collaborate with Executive team to clarify specific project requirements and goals Define scope of projects and establish realistic long and short term objectives aligned with company goals Establish, manage, and adjust detailed project schedule EXPERIENCE Minim
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Exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results Organize (sometimes independently or collaboratively) the relevant safety data analysis for Safety Review meetings Verify adequate documentation of meeting minutes Create and maintain an effective signal tracking process that fully documents signal evaluation activities and can be used for regulator
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Required Education, Experience and Certifications Be a key contributor to DMPK strategy by acting as a Subject Matter Expert on interdisciplinary project teams. Identify critical ADME/PK related issues; align and collaborate with cross functional drug discovery teams to support lead optimization and development candidate selection. Collaborate with preclinical pharmacology and toxicology functions
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Design clinical strategy and clinical trial design Collaborate with our multi disciplinary Development Teams, consultants, and external advisors to deploy novel series of drugs that will have the maximum impact for patients Generate clinical and regulatory documents required for the initiation and conduct of clinical trials, particularly Phase 1b and 2 trials in oncology Interpret and report clini
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Represent Regulatory Affairs in cross functional meetings and initiatives for assigned Participate on core projects and/or provide RA guidance/strategy Develop regulatory strategic plans to execute strategies for regulatory submission Collaborate with team members to ensure agreed timelines and milestones are met Review critical documents to ensure compliance with relevant regulations/guidance pri
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Perform product investigations for the complaints received including the diagnosis, failure analysis, root cause determination, and the completion of the complaint investigation report Oversee the Complaint Management process by providing direction for the Complaint Team and technical support Coordinate the actions of the Complaint Review Committee (CRC) to ensure that adverse events involving the
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