- Insmed Incorporated (Trenton, 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 ... role and can be located in or around: Trenton, New JerseyResponsibilities Develop, lead , and execute a sales plan with specific goals and targets to maximize… 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)
- …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)
- …opportunity employer including veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the ... at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be...with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and ... a library of educational slides to be used for Investigator Meetings, Site Initiation Visits (SIVs) and other educational needs across assetsPartners with IT… 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. (North Wales, PA)
- …trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck & Co. (North Wales, PA)
- …globe. Working with the Asset Development Team (ADT's), early- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific ... clinical biomarker strategy by incorporating critical insight from discovery...author protocol-specific biomarker plans and ensure their efficient implementation.- Co- lead a regularly scheduled biomarker meeting for the development… more
- Merck & Co. (North Wales, PA)
- …of study start up by reducing the time from study initiation to first site ready.Remove obstacles and enable the Global Clinical Trial Organization to focus ... relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) 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. (North Wales, PA)
- …aggregating individual program information to a portfolio viewEstablish robust CMC and clinical stakeholder interfaces to maintain a pulse on all programs within the ... appropriate tools, dashboards, and business systems.Manage cross divisional workstreams and lead or input into improvements to processes / templates that support… 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
- Insmed Incorporated (Bridgewater, NJ)
- …at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Merck & Co. (North Wales, PA)
- …is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer: ... Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator's brochures, clinical sections of… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes managing ... Quality Leaders and approving critical site nonconformance investigations, owning projects related to Quality, and...to the Quality Leaders about handling the various nonconformances. Lead the daily touch point meetings with the team… more
- Lundbeck (Philadelphia, PA)
- …may include organizationalleadershipC-Suite roles (CEO, CFO, CBO), VP Finance, VP Clinical Ops, Specialty Pharmacy, Outreach Coordinator, Infusion Site Directors ... the Reimbursement Teams.ESSENTIAL FUNCTIONS:Customer Engagement Strategy, Execution and Pull-Through Lead development of and execution of account-specific strategies that… more
