- 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)
- …Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Senior/Executive Director /AVP in ensuring… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Clinical Director will manage the entire ... and joint internal/external research project teams relevant to the development of new compoundsThe Clinical Director...relevant to the development of new compoundsThe Clinical Director may:Supervise the activities of … 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
- Merck & Co. (Rahway, NJ)
- …clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity, ... Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting… 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
- 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)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Clinical Safety global business processes. This includes defining and...as our company's QA, GCD Standards, and Learning & Development . This collaboration is essential in developing and executing… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex ... areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically… 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
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development , ... Job DescriptionOur Clinical Development teams manage studies to...will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT lead may be responsible for:-Evaluating pre- clinical… 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)
- … Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...least 5 years global or US medical affairs or clinical development experience with proven track record… 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … more
