- 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)
- … 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... initiative to make decisions for QADC collectively with the QADC team.Act as site subject matter expert for "Good Manufacturing Practices" and SOPs related to batch… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... partner to support the Supply Chain and Operations department. Act as site subject matter expert for "Good Manufacturing Practices" and "Good Distribution… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes ... Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers. Harmonize with Environmental,… more
- Insmed Incorporated (Bridgewater, NJ)
- …responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or ... Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line. This role leads the protocol… more
- Insmed Incorporated (Bridgewater, NJ)
- …The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums.ResponsibilitiesField Medical Strategy - Develop ... Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop consistent… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission documents (eg, IBs,… more
