- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… 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
- Tris Pharma (Monmouth Junction, NJ)
- …for an experienced MD to serve as Senior Director or Director , Clinical Development . Title and salary commensurate with experience. The position ... is a core member of the Clinical Development management team responsible for developing and implementing, in alignment with corporate strategy, the clinical … 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
- Novo Nordisk Inc. (New York, NY)
- …educational workshops, round tables, medical forums, etc. May explore and identify sites for clinical trials in all stages of development . Incumbents have a deep ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...scientific role tasked with working closely with the group Director to define group strategy and to lead a… 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)
- …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
- 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)
- …(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
