- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... hybrid position. Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior … more
- Merck & Co. (North Wales, PA)
- …Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively ... team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular will be responsible for overseeing and facilitating research in cardiovascular disease with an emphasis on ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Aequor (Waltham, MA)
- Job description Job title - Director , IT Operations, and Infrastructure Location - Waltham, MA 02451 Permanent fulltime role Hybrid role - 3 days onsite, 2 days ... remote Position Summary: The IT Operations Director will oversee the operation of server systems, networking equipment, cloud platforms, and GxP environments,… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... focus on uncovering novel biology in immuno-metabolism to deliver a high- quality drug discovery pipeline.We are a research-driven biopharmaceutical company. -Our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products within responsible therapeutic / franchise area(s). Relationships Reports to Senior Director , Value Communication and Contracting Strategy. Interacts ... frequently in collaboration with internal management and senior level managed markets customer representatives. Interacts internally with team representatives from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical Study Reports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for developing and continually growing strong relationships with DS internal senior stakeholders to assess, develop, implement and drive execution of Strategic ... responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research...plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research… more
- Merck & Co. (North Wales, PA)
- …company's innovations and improve patient health outcomes. Under the guidance of a senior leader, this individual will serve as an Oncology, V&I, Outcomes Research ... to value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
