- Novo Nordisk Inc. (Plainsboro, NJ)
- …and is able to provide clear direction on Medical Affiars engagement needs to the clinical data science & evidence team and other relevant functions As a senior ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...investigators and provides feedback to sites to other groups Lead a strategic leadership team , poactively assesses… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …company's autologous and allogeneic cell therapy portfolio. Key Responsibilities Build and lead a talented team to develop novel technology and platforms for ... myeloma. Legend Biotech is seeking a (Sr.) Director, Cell Therapy as part of the US R&D team...to solve problems. Proven leadership skills to build and lead a research team to advance company… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and Delivery (OED).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the US. Within the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ ... accountable for resourcing, development, training and management of a highly performing Clinical Operations team . The position will provide strategic direction… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Investigations Lead has the responsibilities for providing quality oversight over...quality oversight over the production of a personalized cell therapy to support both clinical and commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a ... treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the...QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Shop Floor Lead is an exempt level position with responsibilities for...quality oversight over the production of a personalized cell therapy to support both clinical and commercial… more
- Eisai, Inc (Nutley, NJ)
- …impairment due to Alzheimer's disease (AD) or mild AD. The Area Business Leader (ABL) will lead a team of Neurology Account Specialists (NAS) that are part of a ... diverse team of professionals supporting this important launch and will...sales objectives. This will be accomplished by conveying complex clinical information to customers and key stakeholders regarding FDA-approved… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner ... Biotech is seeking a Technical Trainer as part of the Technical Operations team based in Raritan, New Jersey. Role Overview Technical Trainer will be responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training team who lead training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. ... Biotech is seeking a Training Supervisor - Operations as part of the Training team based in Raritan, NJ. Role Overview The position will be responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The Quality Systems Lead role ... for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical ...portfolio of ongoing projects. Ability to work with and lead others in a team environment. Experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … team , responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP ... is seeking an Operations Supervisor (2nd shift) as part of the Technical Operations team based in Raritan, NJ. Role Overview The Operations Supervisor is an exempt… more
- Aequor (Thousand Oaks, CA)
- …of regulatory submission documents that comply with global regulatory standards. Write or lead all aspects of the writing of clinical study reports and ... Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a ... Lead the daily touch point meetings with the team and monitor workload. Lead the daily...aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy . A… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role Overview This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner ... with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP… more
- Novo Nordisk Inc. (Chicago, IL)
- …competency of the medical team and supports strategic projects aligned to the Therapy Area (TA) priorities. The SD works closely with the TA Leadership Team ... the SD serves as a key member of the Clinical Trial Strategy Team , provides additional analytic...the region to enhance territory management of field teams Lead project teams to manage and support various projects… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will ... seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the Technical Operations team based in Raritan, NJ. Role Overview This position… more
- BioAgilytix (Boston, MA)
- …novel therapeuticsPlan and direct experimental design and executionDrive pre- clinical and clinical trial projects with study team to align with client ... and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored...the patients who need them.In this role, you will lead the development and validation of Biomarker assays to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives ... is seeking a Sr. Associate OpEx Engineer as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing… more
- Kolmac (Columbia, MD)
- …of choice Will provide weekly updates to the Regional DirectorResponsible for leading Clinical Treatment Team meetings and ensuring best clinical practices ... history reportEnsures completion of the Discharge Cleanup ReportAny new operational or clinical incentives or reportsMay carry a group therapy or individual… more
