- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the project management information systems and communicates risks/issues to GPM senior management in a timely manner. Prepares scope change proposals and ... drafts stage gate proposals for formal presentation to senior management .Generates and maintains high quality risk management and communication plans.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timelines, milestones and goals to the project team, department leadership, and senior management .Ensure project documents are complete, current, and available ... modifying them as appropriate to meet changing needs and requirements of each program .Track program scope, costs, expenses, and budgets against defined metrics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs...and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... immune disorders. Summary Oversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical trials;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program . Evaluates CMC changes for portfolio biologics and ... areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... Group Lead will be responsible for overseeing multiple program -level CS Asset Leads who are managing a team...to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations, BDM and DLT membersHe/she will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), ... is responsible for assisting with defining compound/ program medical strategies and for leading select Medical Affairs projects within gynecological oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and ... with strong interpersonal skills to influence cross-functional and cross-regional senior leaders with collaborative mindset required- Prior experience in project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and ... senior leaders with collaborative mindsetPREFERREDPrior experience in project management or leading change management initiatives.Prior experience in… more
- Insmed Incorporated (Bridgewater, NJ)
- …required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program ... and associated functional plans. As a leader, the Sr. Director of Program Management will...and recommendation through proactive communication to the teams and Senior Leaders. Drive teams to meet or exceed goals… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Medical Process Excellence will be responsible to develop and evolve ... Strategy, Field Medical, HEOR, Medical Information, Medical Excellence). The Director of Medical Process Excellence will also work closely cross-functionally… more
- Insmed Incorporated (Bridgewater, NJ)
- …matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and ... outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact of toxicology results… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the Brand team for… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Manager, Commercial Analytics, Respiratory will be a key member of the ... an objective and proactive view of product and market performanceSupport the Director of Commercial Analytics with adhoc requests to prepare for launchPartner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and related materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the ... be part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible for… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …differentiation, and prepares for new indication/label approvals. The Senior Director , CDMA leads a multi-disciplinary program team effectively and ... Job Title Senior Director , Clinical Development & Medical.../critical care required. + 10+ years' pharmaceutical experience in Program Management , Clinical Development and/or Medical Affairs.… more
