- Insmed Incorporated (NJ)
- …each other, 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 ... budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics operations across...IXRS/IRT vendors and other third-party providers in alignment with clinical development and Clinical Operations … more
- Formation Bio (Boston, MA)
- …milestone treatment Partners with Director of Accounting, R&D, FP&A, and clinical operations to ensure accurate financial treatment of scientific and ... 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
- Eisai, Inc (Nutley, NJ)
- …leader with deep expertise in strategic sourcing, vendor governance, and clinical operations within a pharmaceutical environment. Strong communication skills, ... profile, we want to hear from you. The Senior Director of Clinical Outsourcing provides strategic leadership...to resolve operational issues.Routinely collaborates with the Head of Operations to assure outsourcing needs are met and interfaces… more
- Eisai, Inc (NJ)
- …a difference. If this is your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the development and execution of ... systems and a deep understanding of ICH/GCP guidelines and pharmaceutical operations are essential for success.Essential Functions Clinical Outsourcing Develops… more
- Insmed Incorporated (NJ)
- … clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical ... Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help...Investigator Alert letters and SAE reports in collaboration with Clinical Operations .Ensure the medical integrity of … more
- Insmed Incorporated (San Diego, CA)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team ... for patients with serious diseases. Reporting to the Executive Director , Clinical Development, you will support and...will provide clinical and scientific support to clinical development and operations , regulatory, medical affairs,… more
- Formation Bio (New York, NY)
- …life sciences, nursing, pharmacy, or a related field. Minimum of 10 years of clinical project management/ clinical operations experience, including at least 5 ... to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and… more
- Formation Bio (New York, NY)
- …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 ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for patient support field teams. This role will oversee program operations , compliance, vendor contracts and relationship management. AD will drive collaboration ... privacy, compliance and legal. Relationships The position reports to the Director , Patient Solutions and Field Reimbursement. Closely partners closely with MAPA,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides ... research areas centered around rare diseases and immune disorders. SummaryThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
- Merck & Co. (Rahway, NJ)
- …most value to the business area scientists across initial market applications, clinical submissions, and post approval supplements.- In addition, the applicant will ... with the business areas, and project deliverables into a roadmap spanning clinical , first market, and post approval submissions across the pipeline.- The applicant… more
- Merck & Co. (Rahway, NJ)
- …in policy, communications, medical affairs, and PI&ELead the team's engagement with Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to ... Job DescriptionThe Executive Director and Global Lead, Patient Advocacy & Strategic...health organizations and their leadersRequired Skills: Advisory Board Development, Clinical Affairs, Clinical Development, Clinical … more
- Merck & Co. (Rahway, NJ)
- …Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the Business System ... Job Description Associate Director , Regulatory Submissions Archive Operations - Location: Rahway, NJ (Hybrid role - onsite 3 days per week required) - Functional… more
- Genmab (NJ)
- …and operational risk analysis.Serve as a senior strategic partner to Development Operations (DevOps), Clinical Strategy and external partners to inform study ... a fit? Then we would love to have you join us!Overview:The Director , Feasibility Lead, will drive the implementation of strategic, data-driven feasibility practices… more
- Merck & Co. (North Wales, PA)
- …and communicating regulatory strategy as needed to colleagues in Regulatory Operations , Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and ... Job DescriptionThe Associate Director , Regulatory Affairs, supports products in the Oncology...Control (CMC) as well as other functional areas (eg, clinical research, non- clinical safety assessment).Support maintenance (eg,… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Supplies and Development Batches to meet Clinical Development Program requirements.-Partners with Quality, Operations , Technology, and ... Logic ControllersSupervisory Control And Data Acquisition systemsDistributed Control SystemsBatch Operations (S88/S95)Manufacturing Execution SystemsInformation TechnologyOEM equipment.Preferred Experience and Skills:-The… more
- Formation Bio (New York, NY)
- …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 ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Insmed Incorporated (St. Louis, MO)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Collect, synthesize and deliver HCP derived scientific… more
- Insmed Incorporated (NJ)
- … clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations , Regulatory, and Clinical Development, as well ... future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for… more
