- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and resources for the assigned GMA plan activities, in collaboration with Sr Director . Support medical readiness activities for market launches and life cycle ... and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project manager this ... Team and Global Clinical leader to ensure effective team operations through meeting management, development plan/timeline management, scope management, stakeholder… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Job Summary:The Associate Director of Digital and Omnichannel Analytics Technology is responsible for leading ... cross-functional teams, including Omnichannel Center of Excellence, marketing, business operations and market access to implement data collection methodologies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will also serve as the Clinical Science… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Operations and other cross-functional and regional stakeholders. Provides support in review of investigator-initiated studies (IIS) and may serve as ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …integrated summary of safety (ISS) and integrated summary of efficacy (ISE)- Direct Project Support : Providing direct support to key studies in order to ensure ... other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etcQualifications: Successful candidates will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational processes and identifying the latest digital tools and technologies to support MCT activities. The Director serves as primary functional partner ... other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... CROs and External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , People Analytics will execute and drive the strategic vision for People ... identify and prioritize analytics initiatives that drive business outcomes and support HR strategies. Utilize advanced analytics techniques to identify trends,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. ... closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure sucessful implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support : Providing direct support to key studies in order to ensure ... other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. ... closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure successful implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will play a key role in managing QA ... & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure they are...Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).Responsible for QA… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical/commercial manufacturing,… more
