- 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
- Merck & Co. (Rahway, NJ)
- …forecasting in conjunction with Sr .COM /other roles.Executes and oversees clinical trial country submissions and approvals for assigned protocols.Develops ... produce safe, effective, innovative medicine.Under the oversight of the Sr . COM, Head COMs or CRD, the person is...responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … drug development across projects Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators In ... Development organization this is a key new role to lead the Clinical Operations function across our...Clinical Operations line management experience Domestic and international clinical trial execution experience required Post-approval … 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
- Merck & Co. (Rahway, NJ)
- …functional areas and GDMS on cross-functional trial teams and in other trial -level development forums.Under the guidance of more senior staff, may serve as ... Defines trial -level requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol from a clinical … more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results in ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… more
- Merck & Co. (North Wales, PA)
- …Operations Managers (CQOMs), GDMS, BARDS Statisticians and rest of members of the Clinical Trial Teams (including Country roles) to ensure that systems and ... Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the... clinical quality framework.Profound knowledge and understanding of clinical development programs, clinical trial … 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …with a minimum of five (5) years SAS programming experience in a clinical trial environment.Required Experience and Skills: Experience with study data standards ... Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and… more
- Lundbeck (Miami, FL)
- …investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request of Clinical Affairs, assists in clinical trial support by ... airport. Territory consists of Florida, Georgia and Puerto Rico POSITION SUMMARY:The Senior MSL, Neurology will apply advanced field based medical and scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... technologies. Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness… 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
- 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
- Merck & Co. (Rahway, NJ)
- …leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in ... conjunction with functional and clinical development leadership. Responsible for...the integration of internal subject matter expert input and senior management review and approval. Work closely with search… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
