- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support ... activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs)...development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams… more
- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry ... consumer and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support...to support regulatory strategy for product development and manufacturing activities for the Cell & Gene Therapy sites to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... Responsible for managing budgets and resources for the assigned GMA plan activities , in collaboration with Sr Director .Support medical readiness activities… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is ... development and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's… more
- Merck & Co. (Rahway, NJ)
- …Device Working Group to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and… more
- Merck & Co. (Rahway, NJ)
- …representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus ... experience in medical device and/or combination products would be preferred.- Key activities that this position would be responsible for include: leading internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Merck & Co. (North Wales, PA)
- …with marketed compounds.-In executing these duties, the Director may: Supervise the activities of Clinical Scientists in the execution of clinical ... and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in ensuring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …budget and/or resource prioritization process and serve as global coordinator with activities with Japan (forecast updates, special projects, etc.). The person will ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...Clinical Project Budget in support of Phase I-III clinical studies. Partner with Project Management, Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as appropriate to mitigate risks or gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from ... standard processes to facilitate alignment of technology transfer and validation activities across the projects for (mAb, Drug Substance, Drug Product, or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... real-word evidence (RWE), supporting senior management in various epidemiological activities .This position independently carries out various functions (eg, literature… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including, but… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision. By ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... and projects. Provides guidance to study team on all aspects of statistical activities ; collaborates closely with data manager to ensure high quality data.- Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position ... and guidance to the project team regarding the data management DM activities and deliverablesEstablishes Data Management strategy at the project and/or study level… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/ Associate Director , External Manufacture as part of the Global Manufacturing ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
