- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers into clinical development across all therapeutic areas and all phases of ... clinical development at our Research & Development Division ....our Company. Key responsibilities: Serve as a subject matter expert in Genomics assay development and fit-for-purpose analytical validation… more
- Sanofi (Cambridge, MA)
- …research. Experience in the conduct of late phase clinical trials. Education and Training : Mandatory Qualifications: Advanced degree: MD or MD/Ph.D ... Job Title: Clinical Lead, Early Clinical and Experimental...Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaises… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and from different disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. ... understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards,… more
- Eisai, Inc (San Diego, CA)
- …we want to hear from you. Eisai is looking for a scientifically driven imaging expert with deep knowledge of Oncology clinical trials to shape the future of ... candidate will spearhead the development of imaging acquisition strategies, biomarkers, and advanced analytics to support translational and clinical goals. At… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Insmed Incorporated (Minneapolis, MN)
- …Engages appropriately in scientific exchanges around product information, disease education , and research ideas/activities with physicians and ancillary healthcare ... in appropriate prescribing and improved patient outcomes.Field therapeutic area expert demonstrating high scientific knowledge and competency of Insmed therapeutic… more
- Lundbeck (Boston, MA)
- …responsibilities Ensures compliance with all FDA and Lundbeck requirements Required Education , Experience, and Skills: Accredited advanced degree in a ... KOLs and external stakeholders internally to serve as advisors, investigators, expert consultants, authors, or evidence generation partners Executes on MSL goals… more
- Insmed Incorporated (St. Louis, MO)
- …engage appropriately in scientific exchanges around product information, disease education , and research ideas/activities with physicians and ancillary healthcare ... in appropriate prescribing and improved patient outcomes.Field therapeutic area expert demonstrating high scientific knowledge and competency of Insmed therapeutic… more
- Merck & Co. (Rahway, NJ)
- …assays. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of ... authoring and reviewing regulatory submissions and interacting with Health Authorities. Education , Qualifications, and Skills: Ph.D. in cell biology, immunology,… more
- Eisai, Inc (Nutley, NJ)
- …development within the Medical Affairs department for assigned product(s). Utilize expert medical, clinical and scientific knowledge in assigned therapeutic ... medical affairs plan, including post-marketing research, congress management, medical education , research grants, medical advisory boards, and scientific communication/publication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA, Development QA, and PVQA) to address GxP-related issues impacting clinical /medical access programs. Drive necessary change and efficiency through provision of ... data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation… more
- Merck & Co. (Rahway, NJ)
- …and technically focused individual to serve as crystallization subject matter expert . The incumbent will develop isolation processes that deliver desired solid-state ... properties, purity, and yield for clinical programs across our diverse pipeline. This role involves the development of new technologies focused on improving the… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization to serve as a senior technical subject matter- expert and advisor for our Autoinjector platform. This role's scope and accountability ... challenges related to design, manufacturing, and scale-up processes, employing advanced material science principles to resolve issues effectively.- Additionally,… more
- Sanofi (Cambridge, MA)
- …Management skills: Intermediate Scientific Background: Intermediate Business Acumen: Advanced Clinical Development Knowledge: Intermediate Problem Solving ... progress. We are at the forefront of digital transformation in clinical operations, leveraging cutting-edge AI technologies to revolutionize how we prepare… more
- Sanofi (Morristown, NJ)
- … studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of ... to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives,… more
- Sanofi (Waltham, MA)
- …Senior Biostatistics Expert at vaccine project level: Develop with other clinical /medical and global project team members the end-to-end clinical development ... for medium complexity vaccine project (one or several indications) in clinical development and/or post-marketing stage. The incumbent is accountable for all… more
- Sanofi (Cambridge, MA)
- …subject matter expert to provide input in various commercial, medical, clinical market access teams, and strategy development both from Global and US ... such as the integrated evidence generation plan (IEGP) Provide expert reviews to the HEOR research in the forms...demonstrated integrity on work-related compliance considerations and solid ethics. Education : Advanced degree (PhD, MD, MS,… more
- Sanofi (Cambridge, MA)
- …collaboration and teamwork Highest ethical, regulatory and scientific standards Technical skills: Education : Advanced degree in a scientific discipline (MD, PhD ... to be the leaders in patient and scientific knowledge and insights to improve clinical care. We do this by generating and curating the most critical patient and… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- Job Details Job Location Irvine, CA Position Type Full Time Education Level 4 Year Degree Salary Range $120000.00 - $130000.00 Salary Description Job Title : ... Manager, Clinical Affairs (Case...as the primary point of contact and subject matter expert for patient screening process during study start-up Maintain and… more
