- Merck & Co. (Rahway, NJ)
- …involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the entire cycle of ... research project teams relevant to the development of new compounds The Senior Clinical Director may: Oversee the Clinical Directors and supervise… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with ... strategies for that therapeutic area.She/He will strategize and execute Phase IV clinical development programs for assigned products.Design and review IIS… more
- Eisai, Inc (Nutley, NJ)
- …studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for ... for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be...development , planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for… more
- Eisai, Inc (Nutley, NJ)
- …Studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Merck & Co. (Rahway, NJ)
- … trial operations to achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in collaboration with the ... Clinical Research Director (s), the Sr CCQM Lead...Clinical Research Director (s), the Sr CCQM...Clinical Quality Managers (ACCQMs) as well as talent development in collaboration with RCQM. -The role requires the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... will be responsible for resourcing planning, risk assessment strategies, talent development , and partnering to build a culture of innovation and inclusion.-The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, BDM… more
- Merck & Co. (Rahway, NJ)
- …recommendations regarding commercialization strategies, portfolio prioritization and sourcing, clinical development /research strategies, and Business ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for… more
- Merck & Co. (Rahway, NJ)
- … Senior Principal Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling Technologies, ... includes direct project support of the current our Company's clinical pipeline and prospective technology development that...and Scope of Position: This role reports to the Senior Director of Chemical Biotechnologies within Enabling… 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 ... a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety...safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Qualifications- Minimum 9 years experience in the pharmaceutical industry in Clinical Drug Development supporting multiple functional stakeholder groups ... out from associate to leadership levels preferred.- Experience within or supporting Clinical Drug Development processes, roles, data and systems is required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic ...or regional project or be partnered with a more senior project manager in support of a larger, more… more
