Director/sr Director Clinical Research Scientist Iai jobs at Incyte in United States, Wilmington
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Company (1)
Job type
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Job title (1)
United States
State
Wilmington
20 jobs found
11.07.2025
I
Incyte Associate Director/ Director Global Regulatory Affairs Label... United States, Delaware, Wilmington
Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards. Author new and/or revised CCDS, USPI and...
Design and perform experiments for therapeutic proteins using high resolution LC-MS (Qtof and/or Orbitrap) including intact/reduced intact protein mass spec, reduced and non-reduced peptide mapping for characterizing protein primary structure,...
Collaborate with Executive Director IAI and Global Product Team to refine clinical development and commercialization strategies. Evaluate and advance innovative formulations, combination products, and delivery mechanisms for dermatology. Guide late-stage...
Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents...
Governance and Maintenance of all Templates and Clause Library configured into CLM. Govern and maintain contract templates. Collaborate with Legal Counsel and other relevant functional area stakeholders, as it relates...
Maintaining primary and secondary cell lines for further work in assays and biology experiments. Able to conduct assays semi independently and make sound judgements about selecting technical approaches but requires...
Conduct search and evaluation activities to identify pharmaceutical licensing opportunities and strategic collaborations in key therapeutic areas of strategic interest, including immunology and auto-immunity, oncology and dermatology. Lead the assessments...
Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards. Author new and/or revised CCDS, USPI and...
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