- Insmed Incorporated (Bridgewater, NJ)
- …for the successful and timely completion of cross-functional plans. The Sr . Director of Program Management will utilize best-in-class program ... 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... they follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a non-project initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head ... scope change proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a matrix environment and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for ... for the assigned GMA plan activities, in collaboration with Sr Director .Leads medical readiness activities for market...and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on ... 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)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... agreed strategy; Coordinates clinical activities across the project; Represents IPT to Sr . ManagementPeople Management : Leads large study or project teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant...global line management expertise; experience of performance management and development of Director + level staff… 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 ... of these objectives. This position will report to the Sr . Director , Group Leader, GPM&L. Responsibilities Project...drafts stage gate proposals for formal presentation to senior management .Generates and maintains high quality risk… 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...for the assigned GMA plan activities, in collaboration with Sr Director .- Leads medical readiness activities for… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and… 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)
- …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)
- …a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people management , and ... StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for...on plans for successful implementation of studies. Responsible for management of compounds at the program and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leading projects with high impact. preferredAbility to effectively interact with and present to senior management at all levels, as well as to external audiences ... assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and...point person for all GxP matters for the Global Program Head and the Global Program Team.… 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
