- 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)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the...and guide their direct reports in support of their development needs, ensure individual development plans are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … 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
- 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)
- …- The Senior Director will manage the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, ... and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical ...and translational work for the purpose of generating early clinical development plan and Investigational new drug… more
- Merck & Co. (Rahway, NJ)
- …Company's cardiovascular and respiratory medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, and publication.Key Functions: Specific… 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 ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Merck & Co. (Rahway, NJ)
- …help people with cancer across the globe.Working with ADT's, early- & late-stage clinical development teams, the BMx leads will develop asset-specific ... biomarker strategy by incorporating critical insight from discovery biology, clinical development , diagnostics, bioinformatics, molecular assay experts, QP2 and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Merck & Co. (Rahway, NJ)
- …degree (eg, MS, MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the different phases of ... Job Description Job Description: - The drug development Project Manager is part of Global Project...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Merck & Co. (Rahway, NJ)
- …requiring an understanding of biology and high-level scientific concepts and approaches, clinical research and drug discovery and development . Furthermore, this ... Job Description Overview: The Director , Global Media Relations, is responsible for developing and executing a global media strategy that showcases our Company's… more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Merck & Co. (Rahway, NJ)
- …country teams to ensure patient access objectives and strategy are linked to clinical development , commercial and value evidence plans.In partnership with global ... the AVP Global Market Access, Global Pharma, the Executive Director , Global Market Access, Infectious Disease & Ophthalmology will...with the cross functional team including marketing and Product Development Teams (PDTs), (ex. clinical , OR and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and ... external development project meetings. Conduct completeness, scientific accuracy, and ease...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and… more
- Merck & Co. (Rahway, NJ)
- …making and increase commercial rigor through all phases of alliance asset development .Reporting to the Director of Global Commercial Pipeline Analytics, the ... Job DescriptionAssociate Director , Global Oncology Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) organization is charged… more
