- Regeneron Pharmaceuticals (Warren, NJ)
- …for the study + Oversees/conducts site evaluation and selection + Leads investigator meeting preparation and execution + Monitors progress for site activation and ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation + Escalates issues… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (eg, Development Safety ... Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). + Leads cross-functional teams...or more Gilead therapeutic areas and varying stages of drug development is strongly preferred. + Demonstrated ability to… more
- Norstella (Trenton, NJ)
- …strategic and commercial decision making. Together we help our clients: + Accelerate the drug development cycle + Bring the right drugs to market + Identify barriers ... development planning and forecasting + Protocol Design, Country, Site and Investigator Feasibility + Clinical trials operations, cost benchmarking & landscapes +… more
- Taiho Oncology (Princeton, NJ)
- …of our team, you'll have the opportunity to shape the future of drug safety, contribute to groundbreaking research, and advance patient care worldwide. With ... in the review of protocols, informed consents, Company Core Data Sheets, + Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... of product, product environment, and recent literature + Maintain expertise in drug safety and PV, and understanding of international safety regulations and… more
- Bristol Myers Squibb (Madison, NJ)
- …Collaborations (CRCs), Medical Affairs Sponsored Studies (MAST), and Investigator -Sponsored Research Studies (ISRs), ensuring alignment with internal strategies ... + Should have experience in clinical concept development and partnering across the drug development continuum. + Be accountable for delivering CRCs, ISRs, and MASTs… more
- Bristol Myers Squibb (Princeton, NJ)
- …Medical Evidence Generation (MEG) to oversee the execution of the Investigator -Sponsored Research (ISR) programs from concept through full execution, including ... verbal and written + He or she should understand pharmaceutical drug development including clinical development, regulatory, life cycle management of pharmaceutical… more
- Bristol Myers Squibb (Princeton, NJ)
- …Medical Evidence Generation (MEG) to review and oversee execution of the Investigator Sponsored Research (ISR) programs + Provide strategic input in Phase IIIb/IV ... the ability to speak English + Must be familiar with all phases of drug development + Healthcare landscape knowledge & insight + Proven impact and influence with… more
- Bristol Myers Squibb (Madison, NJ)
- …Develop site and CRA training materials and present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data for specific trends ... (5 to 10 years). **Experience Requirements** + Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Ability to… more
- Bristol Myers Squibb (Princeton, NJ)
- …of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (eg, DMC) activities + Drafting/review ... science, clinical research, or equivalent + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Proficient… more