- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...area of responsibility. To accomplish these goals, the Senior Clinical Director may: Author detailed development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune 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. (Bernards, NJ)
- …immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Genmab (Plainsboro, NJ)
- …RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of ... areas centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction,… more
- Merck & Co. (Rahway, NJ)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... writing, and presentation skills.Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development , project management, and/or medical… more
- Merck & Co. (Rahway, NJ)
- …interpretation of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct and indirect ... Job DescriptionPosition Description: Associate Director , Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision ... the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as CDx representative to GPT for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) ... disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate...to the disease strategy and the strategic choices for clinical development and data generation- Develop and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based ... of analytical methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product for our small… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …compliance oversight is in place and all regulations being adhered to.Ensure that Clinical Development activities (ie , protocols) are aligned with GLP/GCLP, ... quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point ... centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights and direction on… more
- Merck & Co. (Rahway, NJ)
- …out R&D activities partnering across the network to enable process and formulation development .- In this position the SMAR&D Director will set guidance, lead ... development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients,… more
