- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Sr Director GPM&L is accountable for delivering an integrated drug development strategy and ... help improve or optimize organizational efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams ... for partnering with the Global Team leader as the Project Management lead on drug development projects. This position...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The Global Oncology Medical Affairs (GOMA) Director , Program Management & Operational Excellence provides strategic planning and ... operational management oversight of GOMA projects, activities, and budgets.The Director , Program Management & Operational Excellence is responsible for supporting… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing ... executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a ... Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically… more
- 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 visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and ... Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements.Expertise in Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or ... cold chain qualifications is strong preferred.Previous management experience preferred TravelMust have the ability to travel up to 30% domestic and internationalDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the ... needs and the respective development stage of the project . The CMC Lead will support the Sr. CMC...support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC Lead of an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to ... Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Continuous Improvement professionals to drive excellence in project execution. Foster an environment of collaboration, innovation, and accountability. ... Build organizational capability by delivering training programs that enhance Lean and Six Sigma skills across the workforce.Innovation and Best Practices Stay current on industry best practices, emerging trends, and innovations in continuous improvement.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …solid foundation of generally accepted BD practices. preferredDemonstrated project management/leadership skills to lead/manage cross-functional teams in evaluating ... target opportunities partnering opportunities and producing high quality assessments of scientific and therapeutic hypotheses, as well as preclinical and clinical data. preferredAbility to drive projects to deliver timely results and follow through on internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Commercial & Strategy, Global Forecasting & Insights and Global Project Management. Successful execution will involve working cross-functionally to gather ... including managing the interface with global/regional teams and ensuring alignment with project assumptions.- Collaborate and set stage with the wider GBD team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are met. Provides information to other internal departments where deemed appropriate.Develop project plans and manages the Year-End payroll project activities ... and approves the payment processing for each payroll. Establishes project plans and calendars for the payroll activities and...and maintain the PTO time interface to the RD Project Time system. Works closely with IT, HR, Equity,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project (s). Strategize and plan for FDA meetings.Serve as the primary ... breakthrough therapy designation requests, orphan drug applications.Participate in global project team meetings (development and/or marketed products); provide regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project . Lead and prepare FDA submissions, including but not limited ... to briefing documents, breakthrough therapy designation requests, orphan drug applications and BLA annual reports. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supported by regular audits, data maintenance and continuous improvement processes. Project Management: Effective management of timelines and deliverables, along with ... experience in Agile and Waterfall methodologies, is essential. Preferred SkillsPractical experience in SuccessFactors as a functional consultant or configurator or SuccessFactors Certification would be highly regarded preferredStrong people leadership skills… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …define problem statements and provide efficient solutions required- Demonstrated project /program management experience required- Certification in one or more ... SuccessFactors modules including Employee Central, Onboarding, Recruiting, Performance, or Compensation preferred- Hands-on experience implementing a global HRIS solution preferred- Solid influence and negotiation skills. Strong vendor management skills… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
