- Daiichi Sankyo, Inc. (Bernards, NJ)
- …transparent communication.Member of the Clinical Operational leadership team and global clinical operations committee enabling cross functional and regional ... other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations… more
- Merck & Co. (Upper Gwynedd, PA)
- … Clinical Trial Development, Communication, Data Analysis, Decision Making, Drug Development, Ethical Standards, Evidence-Based Medicine, Global Health, ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication;… more
- Eisai, Inc (Nutley, NJ)
- …(QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection ... potential. Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country/region in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... our therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively...for any projects that definitively require a CDx for drug registration or for any project with CDPs containing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of ... individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management,… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...and translational work for the purpose of generating early clinical development plan and Investigational New Drug … more
- Merck & Co. (South San Francisco, CA)
- …of complex therapeutics. - Preferred: Knowledge in cardiometabolic and/or ophthalmology clinical drug development programs Expert skills in experimental design, ... non-traditional therapeutics like peptides, novel biological constructs, and others. The Associate Director is a skilled quantitative drug developer, with a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships with ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development required- Deep ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Advisory Panels at certain scientific conferences. Lead the Translational Subteam within the Global Project Team for the drug program. Present as needed at ... and ability to define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development.- Deep knowledge… more
- Merck & Co. (Rahway, NJ)
- …(BPR&D). The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next ... of 3-4 exempt and non-exempt employees to support bulk clinical manufacturing of biologic drug substances, and...coordination efforts with colleagues across the local site and global our company network in shaping and implementing next… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Durham, NC)
- …Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate will ... is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and… more
- Merck & Co. (Rahway, NJ)
- …product development teams and internal partner groups (quality, analytical,- procurement, and global clinical supply). Projects may include solid oral dosage ... Business, Business Management, Cross-Functional Teamwork, Decision Making, Dosage Forms, Drug Delivery, Feasibility Studies, Financial Management, Global … more
- Eisai, Inc (Nutley, NJ)
- …from you. The Oncology US Medical Excellence and Training role will work closely with Global & US Medical Education and Training colleagues and with the Global & ... judgment; b) effectively communicate relevant and fair balanced scientific and clinical information about Eisai's products; seek feedback from MSLs, MSL Management… more
- Insmed Incorporated (San Diego, CA)
- … development experienceKnowledge or experience of neurology and/or ophthalmology drug developmentExperience with IND/CTA submissions and global registration ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader… more
- Merck & Co. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure).The Senior Director will manage the entire cycle of ... monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and translational… more
- Genmab (NJ)
- …approve the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review, and approval of ... us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible ... Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be... regulations and guidance, especially as they relate to global labelingUnderstanding of clinical development of novel… more
