- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug ... effectively across all departments, such as Quality Assurance/ Control, Chemical Development , Program Management, Regulatory, Analytical Development ,… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a team ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...and Responsibilities: Program Leadership and Technical Project Management:Provide program leadership in the development , commercialization, and… more
- Merck & Co. (Rahway, NJ)
- …seeking an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and ... late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics… more
- Insmed Incorporated (NJ)
- …with FDA, EMA, and other global regulatory agenciesDeep understanding of the drug development processHighly organized with strong attention to detail, accuracy, ... global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to… more
- Merck & Co. (Rahway, NJ)
- …Change Management, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Drug Development , Logistics, Multiple Therapeutic Areas, Process ... to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and… more
- Insmed Incorporated (NJ)
- …a broad understanding of pharmaceutical development !Expert knowledge of all phases of drug development , of the functions and processes relevant to drug ... and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning… more
- Genmab (NJ)
- …performance in the modern sales environmentPartner and pull through training and development to create a modern learning program which provides employees ... like a fit? Then we would love to have you join us!The Regional Business Director will help recruit, hire, develop, and lead his/her sales team in hematology for… more
- Insmed Incorporated (NJ)
- …of relevant guidelines including, but not limited to medical and regulatory affairs, drug development , FDA and regulatory guidelines (ie, PhRMA guidelines, OIG, ... the future of science, we're in. Are you?About the Role:The Senior Director , Medical Services will provide strategic leadership to Insmed's independent medical… more
- Insmed Incorporated (NJ)
- …of R or other statistical software packages Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory ... Sets tasks, prioritization, and resources within assigned compound(s) Provides program -level programming leadership and support to clinical development … more
- Insmed Incorporated (NJ)
- …is preferred.Knowledgeable in all aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems ... 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of operational… more
- Merck & Co. (Rahway, NJ)
- …of relevant experience. Required Experience and Skills: Experience with small molecule drug substance and/or biologics process development and scale-up, moving ... Customer-Focused, Data-Driven Decision Making, Deviation Investigations, Driving Continuous Improvement, Drug Product Development , Estimation and Planning, Fast-Paced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …processing activities such as data acquisition, collection, seriousness and coding ( drug /event), narrative development , and case assessment Ensure alignment with ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers… more
- Merck & Co. (Rahway, NJ)
- …Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Device Development , Diversity Awareness, Drug Development , Human Factor ... Development (DPPD) Team, which focuses on the design, development , and commercialization of novel biologic/ drug /vaccine-device combination products for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance considerations into research planning and execution across all phases of drug development Develop and maintain Patient Safety onboarding and ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an ... and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US...providing the HEOLs with an individualized view of their development plans and ongoing performance. This is a remote… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …leads to ensure harmonization and alignment across all functions and sites.Support the development of the GMP Compliance program related to clinical/ commercial ... will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role OverviewWe are seeking a ... highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical...from early research through IND-enabling studies and into clinical development , ensuring regulatory compliance and scientific rigor in support… more
- Merck & Co. (North Wales, PA)
- …assessment of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise ... role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the… more
- Eisai, Inc (Nutley, NJ)
- …and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads the ... requirements on the Clinical Pharmacology and Translational Medicine aspects of drug development .A thorough understanding of standard Clinical Pharmacology… more
