- Merck & Co. (Rahway, NJ)
- …of clinical data/ medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct and indirect team ... : Education Minimum Requirement: Bachelor's Degree +9 years of pharmaceutical, clinical drug development , project management, and/or- medical field… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product ... pipeline.The Director will report to the Executive Director of Sterile Product Development - Mixed... with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Method Development & Testing is responsible for leading a Center of Excellence (CoE) focused on developing and ... and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and… more
- Merck & Co. (Rahway, NJ)
- …EDSA leads a large investigator-initiated studies program in partnership with late-stage development teams in Medical Affairs while also supporting early-stage ... Job DescriptionThe Executive Director , Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific...development teams. The role also partners with Medical Affairs leadership to develop the global Value Evidence… more
- Merck & Co. (Rahway, NJ)
- …access and reimbursement. The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, ... Company's products. -Develop a strong matrix relationship with clinical development , BARDS (Biostatistics and Research Decision Sciences), medical affairs,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This ... of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure… more
- Merck & Co. (New York, NY)
- …study sites and identifies potential investigators to participate in phase II-IV- clinical development programs, conducts Site Initiation Visits (SIVs), and ... Job DescriptionRole SummaryThe Cardiovascular & Metabolism Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and… more
- 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 ... AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science 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, ... possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/ medical contributor; For large or complex… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, ... Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... 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… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… 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, ... AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with...from a medical strategy standpoint to the development of clinical sections of study-level documents… 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, ... AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project management or leading change management initiatives preferred- Prior experience in clinical development , Medical Affairs, or Global Marketing ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets)… 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, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more