- Insmed Incorporated (San Diego, CA)
- …experiencePreferred: A PhD in addition to the above10+ years of management experience in ophthalmology clinical development.Pediatric experience preferred.Gene ... and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical trial diversity to drive informed decision-making with management Experience in ICH-GCP principles, regulatory requirements, and compliance requirements ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...NAO, and NN. Essential Functions Oversight of trial- or program -level diversity plan development within one or more of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety… more
- Genmab (Plainsboro, NJ)
- …position may serve in a lead or co-lead role in the implementation of a clinical trial(s) within a program in alignment with the global development strategy. ... to provide high-quality and timely deliverables.ResponsibilitiesLead or co-lead a less-complex clinical trial(s) within a program .Works in collaboration with a… more
- Merck & Co. (Rahway, NJ)
- …apply his/her knowledge of product development, design control principles and risk management techniques to positively support and influence clinical and ... / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety… more
- Merck & Co. (Rahway, NJ)
- …will support one or more V&I, Outcomes Research teams across the Oncology program . Support value evidence teams in Oncology and contribute to value evidence ... strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research leadership on… more
- Merck & Co. (North Wales, PA)
- …able to convert complex ideas and information into simple readable form.Strong project management skills; Manage at a program level; influences approach/s and ... assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and Skills:… more
- Novo Nordisk Inc. (Boulder, CO)
- …departments, such as Quality Assurance/ Control, Chemical Development, Program Management , Regulatory, Quality Control, Supply Chain, and Clinical Write, ... CMC regulatory activities. The Manager of Drug Product Manufacturing is accountable for clinical phase 1 and 2 drug product manufacturing and will have thorough… more
