- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional training strategies Strategic roadmap including , infrastructure, programs , and document/record management principlesResponsible for the development ... GQAResponsible for development, oversight, and maintenance of GQA training programs to ensure cross-functional transparency and consistencyEnsure necessary support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders, innovative solutions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations for both in-house and outsourced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards. This position reports to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety issues including but not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, leadership,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the global data management strategy across regions and across studies/ programs . Lead DM resource model internalization for both strategy and implementation ... Plans are consistent and regulatory compliant across studies and programs .Promotes Risk Based approaches to data cleaning and reviewProactively collaborates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... with other departments, and coordinating and prioritizing CoE resources for key programs . The role will also provide senior safety leadership and guidance on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due ... diligence activitiesQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university):Master's Degree or equivalent preferred… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team and in driving strategy, management and facilitation of key programs and initiatives, ensuring alignment of strategic priorities, resources allocation and ... In the addition, the individual will help plan the transition of asset programs from early to late-stage development in coordination with the Early-Stage Oncology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the ... launch. May act as CDx representative to GPT for early-stage programs .Assists CDx GPT representative by collaborating cross-functionally to ensure successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as required.Responsibilities- Lead the Global Finance and Procurement Capability Building Program - Design a comprehensive training program for Global Functional ... team. The objective is to design and manage sustainable global train-the-trainer program - Perform periodic skills gap analysis to identify areas of focus across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by ... develop, implement, and maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key global oncology congress-related activities across multi-disciplinary teams (eg Corporate Programs and Events, RD, Medical, Marketing and global colleagues) to ... ManagementCo-lead association relationship with Global Medical Affairs- Support all Programs Grants Committee (PGC) sponsorship submission approvals.- Oversee charitable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …work environment. This pivotal position will report directly to the Senior Director of Operations.Key Responsibilities Champion and lead the employee engagement ... program to cultivate a vibrant culture that empowers and...commitment to the company's shared vision.Craft and execute inspiring programs that empower our pursuit of Strengthening Leadership Capabilities,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:Supports positions from Director through Vice President, as needed, and in so doing will ... meetings with KOLs in conjunction with meeting & events group. Manage the Programs & Grants Committee (PGC) approval process; establish KOL contracts and keep… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
