- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities...Sr . CSM may act as the Study Team Leader for the assigned clinical study and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...quality metrics and share with study team, Operations Program Lead , and Sr . Director for the compound,… more
- Merck & Co. (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head...and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). Contribute to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution:...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO...including time in role such as a Global Project Leader at Sr . Director level or equivalent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be...the Disease Area Strategy Team (DAST), the CS Group Leader will collaborate closely with other members of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ... Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses.-Perform clinical trial simulations to inform dose selection ... the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for working with key… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... or related field and at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal skills and ability to… more
- Eisai, Inc (Nutley, NJ)
- …Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... the therapeutic area. Communicate and represent these plans to upper management/ senior leadership within ESI. Continuously update plans and inform stakeholders of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... rare diseases and immune disorders. Summary The Global Team Leader , is a senior , cross-functional leader...In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He ... difference. If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that Payer and KOL reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act as an ambassador to drive ... functions including but not limited to Commercial, Marketing, Medical, & Clinical Development,ResponsibilitiesGlobal Market Access Strategy- Lead the development… more
- Merck & Co. (Boston, MA)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct… more
- Merck & Co. (Rahway, NJ)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early … more
- Lundbeck (Miami, FL)
- …trials (IIT) aligned with Lundbeck's medical strategies Upon request, assists in clinical trial and research efforts by recommending qualified investigators and ... major airport. Territory consists of Florida, Georgia and Puerto RicoSUMMARY: The Senior MSL, Neurology will apply advanced field based medical and scientific… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums.ResponsibilitiesField Medical Strategy - Develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
