- Merck & Co. (North Wales, PA)
- …work experience.- Required Skills and Experience : Prior supervisory and project management experiences are necessary.Solid knowledge of statistical analysis ... human health. Responsibilities : Supervises a group of statisticians in Late Development Statistics.Provides biostatistical and operational leadership to a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product, and/or analytical development activities and ... will support the Sr. CMC Lead on complex and/or late -stage project or act as main CMC...to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess … more
- Merck & Co. (Rahway, NJ)
- …is responsible for providing strategic program leadership, technical expertise, and project management in the scale-up, development, commercialization, and ... and regulatory compliance.-Essential Duties and Responsibilities:Program Leadership and Technical Project Management :Provide program leadership in the development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development. We are building for the future, creating a distinct ... develop and lead an engaged and skilled team of Global Clinical Project Managers and Clinical Trial Administrators responsible for planning and conducting clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and may collaborate with team on CAPAs, including CAPA responses and approvals Project Management :Collaborates with the PSL(s) to proactively plan and prioritize ... to efficiently evaluate safety is desirable.Microsoft Word, Excel, PowerPoint skills, and Project management skillsAble to work independently with minimal direct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental ... as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision. Prepares… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Cambridge and Seattle reflect the full R&D continuum, from early research through late -stage clinical development. Here, we are building for the future, creating a ... and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and translational scientists and clinical operations. The candidate must have effective project management skills and communicate progress and risks toward the ... of clinical biomarker assays and vendor selection for early and late -stage Daiichi Sankyo projects. Effectively identify, manage, and communicate risks to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead. This position leads labeling meetings for preparation of responses to comments… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development. We are building for the future, creating a distinct ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development. We are building for the future, creating a distinct ... stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East Coast Development… more
- Bristol Myers Squibb (Princeton, NJ)
- …and cross-functional subject matter experts. In addition to direct project management responsibilities of assigned projects, the Director , PM will work ... , PM ( Late Development)** + At the director level, the Project Manager (PM) is...development and monitoring. **Reporting Relationship** + Reports into Senior Director , Project Management (also known… more
- Takeda Pharmaceuticals (Lexington, MA)
- …senior management to develop and set vision for departmental activities and management of resources. + Ownership of Bioanalytics late stage area, responsible ... of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual will… more
- Merck (Rahway, NJ)
- …work experience. **Required Skills and Experience** **:** + Prior supervisory and project management experiences are necessary. + Solid knowledge of statistical ... health. **Responsibilities** **:** + Supervises a group of statisticians in Late Development Statistics. + Provides biostatistical and operational leadership to a… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients worldwide. Join Takeda as a Scientist - Analytical Development (AD) - Late Stage Development where you will independently lead efforts in development of ... part of the Analytical Development team, you will report to Associate Director , Analytical Development. **How you will contribute:** + Develop and leverage strategic… more
- Bristol Myers Squibb (Princeton, NJ)
- …biospecimen information-driven by end-to-end visibility and best in class logistics. Reports to Director in Biospecimen Management - Late Oncology . ... + Scientific degree (Associates, Bachelors, Masters, or higher) or project management or equivalent experience. **Travel:** + Minimal… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Late -Stage Clinical Scientist (non-MD, Director ) is responsible for scientific oversight, data integrity and quality of clinical trial(s) in ... support of the development strategy for programs within the Late -Stage Oncology portfolio. The successful candidate may have managerial responsibility for one or… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Associate Director , Project Management is an integral member of the Product ... Integrated Development Strategy. As a senior, highly experienced team member, the Associate Director , Project Management is responsible for monitoring the… more
