- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be...with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site -Launch activities and associated teams ... or gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...build connections, and work across boundaries. Proven ability to lead the planning and execution of cross-functional strategic change… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be ... Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA by overseeing… more
- Merck & Co. (Rahway, NJ)
- …Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, ... enabled combination products to achieve safe and effective delivery to their intended site of action.- The DD Team manages the development of the device constituent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Merck & Co. (Rahway, NJ)
- …and digital solutions are implemented, and sponsor technology adoption across site operations to ensure value delivery on agreed business outcomes. Provide ... product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations Technology… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets… more
- Merck & Co. (Rahway, NJ)
- …Business Development opportunities. Leverage scientific acumen to partner with discovery and clinical colleagues in shaping research programs. Lead team analysis ... area capabilities. Partnering with key stakeholders, individual will benchmark competitor clinical data, business models and capabilities to develop insights and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and ... plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of ... clinical development at our company's Research laboratories. TMB laboratories...that support our pipeline.The individual will have the following responsibilities: Lead in the transition of biomarker flow cytometry assays… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Operations ... serve as a primary operations specialist within in the FLEx Sterile GMP Clinical Manufacturing facility.To enable our Company's ever evolving pipeline the new FLEx… more
- Merck & Co. (Rahway, NJ)
- …and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to ... plan for the statistical analysis and reporting of clinical drug and vaccine projects.Set direction for the analysis and reporting deliverables.Negotiate and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Lead the CAPA program for the CAR-T manufacturing site . Oversee metrics, trending, and reporting of relevant quality systems records. Implement ... within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment....and lead CAPA site governance program. Drive continuous… more
- Insmed Incorporated (Edison, NJ)
- …mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along ... a field-based role and can be located in or around: Edison, NJResponsibilities Develop, lead , and execute a sales plan with specific goals and targets to maximize… more
