- 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,… more
- Merck & Co. (Rahway, NJ)
- …Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies: ... of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.Accountable for performance… 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
- 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. (Rahway, NJ)
- …your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, develops,… more
- Merck & Co. (Rahway, NJ)
- …vendors.Drive and influence the technology and innovation strategic roadmap for the clinical end to end data flow in partnership with functional stakeholders, ... capture appropriate KPIs.Provide leadership and subject matter expertise to the clinical platform by enabling new capabilities of the assigned business area.Become… 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
- 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
- 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
- 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
