- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... data acquisition and validation, and tools to support project portfolio across drug programs . This role is responsible for ensuring the quality and timely delivery… more
- 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)
- …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)
- …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 , 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)
- …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 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)
- …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)
- …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)
- …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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- … program support projects, working collaboratively with the Senior Director , Directors, Associate Directors, and cross-functional teams.- Ensure in-line teams are ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...and partners.Enhancing portfolio management and oversight to ensure strong program plans, identifying key risks, and ensuring proactive postures… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the ... skills in SAS systems and application development and experience. The Associate Director must be a highly specialized individual contributor or functional manager… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... in given geography.Activities of all cluster/country level GCTO team & all programs and studies.Approved administrative budget to support GCTO team (eg, salaries &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is ... seeking a Global Director of Platform Innovation within our Global MSAT organization...advancements and commercial process platform for our Cell Therapy programs . Based in Somerset, NJ, this critical leadership role… more
- Merck & Co. (Rahway, NJ)
- …Operations, Innovation & Technology team's responsibilities include financial management, program law firm management, legal records and information management, ... increasing overall operational effectiveness.We are seeking a dynamic and experienced Associate Director of Outside Counsel and Vendor Management to join our Legal… more
