- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study(ies);… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... and people with disabilities. SummaryReporting to the Disease Area Strategy Team (DAST) Lead for Lung Cancer [Breast Cancer], this position is an integral part of… 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 ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the...including time in role such as a Global Project Leader at Sr. Director level or equivalent… more
- Merck & Co. (North Wales, PA)
- …execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead , you will collaborate with global, cross- functional team-members including ... trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... veterans and people with disabilities. SummaryReporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is an integral part of R&D and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on ... on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program medical ... well as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking an exceptional scientific leader for the role of Distinguished Scientist which is an Executive Director level reporting to an ... Associate Vice President in Development Sciences & Clinical Supply . The Distinguished Scientist will provide scientific direction and partner with the Development… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... senior management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory… 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 R&D ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for… more
- Merck & Co. (Rahway, NJ)
- …upper management and other disciplines to drive enterprise decisions.May serve as a program lead on programs that carry significant technical and/or operational ... process development, and/or engineering and regulatory science.Proven ability to lead program development teams using project management skills.Preferred… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development… more
- Novo Nordisk Inc. (Chicago, IL)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities for the portfolio of mature brands. Relationships Reports to Executive Director , Mature Business Unit - Head. Interacts frequently in collaboration with ... initiatives including but not limited to KOL development, advisory boards, clinical communications and medical education programs Responsible for the development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... operations with a focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare Disease patient HUB… 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 & Privacy Department's Government Accountability … more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... senior management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and subsequent manufacturing campaignsMaintain… more
