- 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 ... resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration 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 ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for...a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for… 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) ... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she...disease area and compound/Drug. May serve as speaker for program / franchise medical/scientific training - Guide the Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Insmed Incorporated (Bridgewater, NJ)
- …limited to, the following:Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important...This opportunity will require a focus on all the clinical aspects of the upcoming HS program .… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing,… 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 ... resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure...relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships… more
- Merck & Co. (Rahway, NJ)
- …Standards Working closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data ... Job DescriptionPosition Description: Manager, Operations and Reference Data Management, Global Clinical...into implementation of strategic direction.In support of the Senior Director , Operations and Reference Data Management, ensures… more
- Merck & Co. (North Wales, PA)
- …in organization development and building a new team.Reporting to the Executive Director of CMC Integrated Project Management, the core responsibility of this ... to manage the Vaccines portfolio of products within CIPM. In addition, the Director will be expected to mentor/coach Project Managers (PMs) (through direct and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, develops, and ... technical device development team(s) supporting individual drug assets currently in clinical development with line of sight to commercial filing and launch.… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... 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
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians. The Director , Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating one or more of the following… more
- Merck & Co. (Rahway, NJ)
- …at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including, but… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay… more
