- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA ... in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission ... Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... cross-functional Device Working Group to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and… 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
- Merck & Co. (Rahway, NJ)
- …medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...study level time, cost and quality deliverables. Lead the development of the clinical study plan including… 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 ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… 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
- Merck & Co. (Rahway, NJ)
- …healthcare market dynamics across the value chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, ... Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for...areas across the team - related to engagement in clinical , business development and omnichannel and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... management, clinical operation and other functions) to implement clinical development plan: study ideation, protocol development , review case report… more
