- 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 ... Plan and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional operational and program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... Global Clinical leader to ensure effective team operations through meeting management , development plan/timeline management , scope management , stakeholder… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …modifying them as appropriate to meet changing needs and requirements of each program .Track program scope, costs, expenses, and budgets against defined metrics ... Communicate and monitor budgets in partnership with the Finance Lead for each program .Provide complete tracking of all program phases and activities, including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… 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 ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… 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 ... a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for...global line management expertise; experience of performance management and development of Director + level staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …before the IST for the creation and execution of development strategy for a program .People Management : Direct reports management - Hire and retain high ... pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the ... Senior Director , GMA Oncology (Global Medical Affairs team lead for...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data driven, and learner-obsessed with experience in developing and managing a learning program from content to delivery. ** Prior to applying, review the Education ... technical learning solutions and other performance enhancement solutions (eg, management reinforcement, rewards, role clarity, job aids).- Facilitates scientific and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level for a larger number of projects/studies with greater complexity.Ensures data management deliverables for all studies within the project/ program level meets ... immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical ... perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior… 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 mindset required- Prior experience in project management or leading change management initiatives preferred- Prior experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; ... CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material… 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 ... cross-regional senior leaders with collaborative mindsetPREFERREDPrior experience in project management or leading change management initiatives.Prior experience… 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)
- …immune disorders. Summary Oversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical trials; ... perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior… 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 ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Insmed Incorporated (Bridgewater, NJ)
- …with Regulatory project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for creating (and/or updating) labeling content, ... computer skills including high proficiency in MS Office and labeling management applications Excellent verbal and written communications skills Detail oriented… more
