- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical… more
- Insmed Incorporated (Bridgewater, NJ)
- …activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable for all ... for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program management support to… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and a working knowledge of global regulations and guidelines regarding drug development (incl. CMC), regulatory submissions and corresponding regulatory agency ... interactions globally4 or More Years Experience in coordinating Regulatory Intelligence & Policy activities in one or more regions (USA required), incl. maintaining a database of regulatory intelligence and coordinating engagement with industry trade… more
- Merck & Co. (Rahway, NJ)
- …in developing and coordinating statistical activities supporting drug /vaccine projects.Interacts with Clinical, Regulatory, Statistical Programming, Data ... guidance to others in the statistical support for clinical drug /vaccine projects.-Interacts with Academic Research Organization (ARO), Contract Research Organization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... drug portfolio from the Research stage to post marketing/lifecycle...a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety… more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... developing, and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice… more
- Merck & Co. (Rahway, NJ)
- …of other scientists and a portfolio of projects and leading pharmacometrics efforts on drug development programs. Senior Directors are expected to have or be ... chemical entities and biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... and Controls) activities of the portfolio small molecule and biological drug products consistent with the company goals; specifically, for the life-cycle… more
- Merck & Co. (Rahway, NJ)
- …scientific leader for the role of Distinguished Scientist which is an Executive Director level reporting to an Associate Vice President in Development Sciences & ... data science and analytics. Experience in one or more of the areas of Drug Substance development, Drug Product development or Analytical Research is critical for… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Director , Business Development - Enabling Technologies Search and Evaluation Job The Search and Evaluation (S&E) team is a core ... in-depth understanding of the underlying science behind each opportunity. The Director , Business Development & Licensing - Enabling Technologies Search and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, ... and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …requirements for transfers of value, price reporting, disclosure requirements, sharp/ drug takebacks), Representative and Organizational licensure (eg, OR rep ... Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities.Summary: The Director , GPM&L drives development and execution of programs, projects, and ... strategic initiatives for Daiichi Sankyo global R&D function. The Director will be able to independently define and execute...our strategic initiatives, work across the organization and with senior leaders to ensure input and collaboration to meet… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting ... to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this...contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact of toxicology results… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as...quality oversight of manufacturing operations and the release of drug substance and/or final drug product to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... team with strong interpersonal skills to influence cross-functional and cross-regional senior leaders with collaborative mindset required - Prior experience in… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will… more
