Jobs in All Categories (11) Healthcare (4) Human Resources & Legal (1) Science & Education (5) Technology (1)
Lead analytical team to develop physiochemical and functional assays to support process development, formulation development, characterization and release of therapeutic candidates at all stages development.
Directs the development and maintenance of Case Report Form (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans.
Proactively develop regulatory strategies for optimal product development under proclaim with an eye towards successful product launch.
Providing technical/scientific leadership for protein mass spectrometry method development, as well as the execution of activities internally and externally at CROs, if needed.
Collaborate with team leaders in discovery, protein engineering and pharmacology to manage supply of therapeutic protein candidates of appropriate quality for use in in vitro and in vivo studies.
Serve as pharmacology/toxicology representative on cross-functional project teams with accountability for developing and implementing nonclinical safety strategy.
Interpret and analyze data, contribute to bioanalytical reports, and communicate the findings to project teams.
Provide strategic input to the Clinical Development team and investigate new indications for molecules in development.
Provide medical monitoring for clinical stage programs and function as the clinical representative on the cross-functional project teams.
Support multiple quantitative clinical pharmacology deliverables, both with hands-on contributions and via oversight of work conducted by external vendors.