- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with relevant DS stakeholders (e. g. corporate tax team). Performance Management , Quality Oversight Provide effective CRO performance management ... of questions exist.Participate and provide input at appropriate functional oversight bodies.Support and drive relationship management and optimization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic ... management experience required.Proven strategic and innovative thinking required.Functional management experience, managing resourcing and budget planning/ oversight … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 - Phase ... 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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This 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 members. He/she… more
- Merck & Co. (North Wales, PA)
- …of the role may include but are not limited to: Provide Account Management oversight and leadership within the Marketing Operations domain. Establish and ... everyone to be more productive and enable innovation.The Associate Director - IT Account Management role is responsible... Management role is responsible for providing Account Management support and IT program leadership across… 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 ... support to provide end-to-end oversight of the program strategy and management for initiating, planning,...and associated functional plans. As a leader, the Sr. Director of Program Management will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? ... activities for the portfolio of mature brands. Relationships Reports to Executive Director , Mature Business Unit - Head. Interacts frequently in collaboration with… 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 ... leadership and overall strategic oversight of study management and delivery for all therapeutic areas. The role...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
- Eisai, Inc (Nutley, NJ)
- …components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… 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 ... on plans for successful implementation of studies. Responsible for management of compounds at the program and...Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in… more
- Insmed Incorporated (Bridgewater, NJ)
- …which include oversight of raw material qualification, lab investigations, stability program , etcProvide oversight of QC equipment program , which ... and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality...play a key role in managing QA and QC oversight activities for Insmed. He/she will be responsible for… 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 ... (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ensure compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The ... position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance &...that the E&CDepartment takes a holistic view of risk management , considering broad organizational priorities as well as external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission ... point person for all GxP matters for the Global Program Head and the Global Program Team....operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight of information included in ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working with the… 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
- Merck & Co. (Rahway, NJ)
- …- Ops and Reference Data Management is responsible for the day-to-day oversight of the Program Managers and their deliverables. This includes responsibility ... closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management ...selection of new hires.The Manager will mentor and guide Program Managers and ensure they work in a consistent… 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 ... a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This...Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight : Responsible for the … more
- George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) ... Protection Program (HRPP), animal care and use program , and oversight committees for the use...research involving human embryonic and/or pluripotent stem cells. The Director is also responsible for administrative oversight … more
