- Merck & Co. (Rahway, NJ)
- …following responsibilities: Design and implement biomarker strategies for early and late-stage clinical programs. - Lead clinical biomarker sub-teams as part ... Job DescriptionAssociate Principal Scientist, General Medicine Therapeutic Areas Biomarker Lead Job DescriptionTranslational Biomarkers (TB) is responsible for the… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory,… more
- Merck & Co. (Rahway, NJ)
- …global lawmakers on industry best practices and requirements for effective global clinical research.Co- lead our network of 250+ Global Privacy Stewards who ... -The primary responsibility of the Deputy Chief Privacy Officer is to lead the team responsible for internal and external stakeholder engagement, working in… more
- Merck & Co. (Rahway, NJ)
- …results aligned with enterprise goalsDevelop an incoming and release testing strategy, lead siting discussions for clinical and commercial testing, and develop ... Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at various… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will ... collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis ... The Executive Director will manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase V, including development of program strategy… more
- Merck & Co. (Rahway, NJ)
- …individuals who lead multi-tumor asset teams (asset team leads). Any clinical development staff reporting to the ATL will be indirect reports.Education:M.D or ... corporate goals and providing critical therapeutic area insightsManagement experience in a clinical development settingProven ability to lead a high performance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUS Lead , Medical Modernization - V&IReporting to the Head of Strategy Realization, Medical Modernization, the US Leader for Medical Modernization (MM) ... new content, tools and scientific engagement capabilities for the V&I organization.-- The US lead will work directly with the Global and US TAs to assess and… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical ... is your profile, we want to hear from you.The Clinical Trial Assistant will support all phases of ...the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials.… more
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... is your profile, we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of… more
- Merck & Co. (Rahway, NJ)
- …Skills:Adaptability, Adaptability, Analytical Chemistry, Branding, Brand Management, Clinical Data Interpretation, Communication, Corporate Branding, Data Analysis, ... Data Science, Experimentation, Financial Management, Financial Performance Management, Global Sourcing, GMP Compliance, Internal Communications, Lab Equipment Maintenance, Laboratory Management, Management Process, Personal Initiative, Pipeline Management,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution o Establish product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... as we embark on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic direction and initiatives within… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of ... clinical development at our company's Research Laboratories. Translational Molecular...of scientific contributions to the scientific community.Demonstrated ability to lead and manage projects in a fast-paced environment.Ability to… more
- Formation Bio (New York, NY)
- … and regulatory documents to support drug development programs. Experience as lead writer for key clinical and regulatory documents required. Experience ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Merck & Co. (Rahway, NJ)
- …submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory single point-of-contact for ... products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist (Senior Director)… more
- Merck & Co. (Rahway, NJ)
- …Manager to join the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will ... with external vendors of predictive and modeling and simulation tools supporting pre- clinical and non- clinical development, and data to assess opportunities and… more
- Merck & Co. (Rahway, NJ)
- …continuity of supply, and commercial outcomes.The VCM Product Manager will help lead the cross-functional Supply Chain Working Group (SCWG) for pipeline products or ... or Value Chain Management Team (VCMT) for commercial productsSupport and/ or lead commercial siting selection, supply chain design, and value stream mappingAssist in… more
- Merck & Co. (Rahway, NJ)
- …models to extract meaningful insights and outcome research evidence. Unstructured Clinical Data: Utilize transfer learning, fine tuning, GAN, transformer, attention, ... to provide data-driven insights and solutions. Project Management: Independently lead Real-World Evidence outcome research or advanced AI/machine learning research… more
- Merck & Co. (Rahway, NJ)
- …achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a ... challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for… more
