- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker , PK / PD ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Bristol Myers Squibb (Summit, NJ)
- …the late stage TM group. The individual will be responsible for TM and clinical biomarker activities to support drug development programs in multiple diseases in ... and validation partnering with Translational Sciences colleagues when applicable + Manages clinical biomarker data delivery and analysis and associated timelines… more
- Bristol Myers Squibb (Summit, NJ)
- …manage multiple complex high-profile portfolio assets and facilitate broad, integrated biomarker plans to enable the delivery of our translational medicine ... integrating scientific and operational expertise to deliver on translational biomarker strategies. Oversee key activities, including data delivery, contracting, data… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads ... and Regulatory Liaisons to ensure successful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally + For… more
- Hackensack Meridian Health (Nutley, NJ)
- **Overview** The ** Director , Research CDI** will serve as the Deputy Chief Scientific Officer (CSO) of the HMH Center for Discovery and Innovation (CDI) as a senior ... assume adherence to the highest ethical standards of research, and facilitate clinical translation of research efforts. This role will work to operationalize the… more