- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to implement new innovative manufacturing technologies.Key Responsibilities This individual with provide direct support to the Director of Manufacturing ... process capability to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings ... direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support; meet aggressive deadlines to ensure that FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas for improvement. Develop and perform assessments when necessary to evaluate the data collected and provide meaningful insights to the deployment of future ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a ... including conduct of impact assessments and implementation of changes as required. Lead development and maintenance of RBQM standards such as guiding principles,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incorporating CI and Market Research insights.- Integrate with the Global Marketing teams and provide a data driven point of view for inline and pipeline asset ... centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting will drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contributes to the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design, participate in ... Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan...any time during the conduct of the study to provide medical inputProvides medical guidance for coding of AEs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring ... with our corporate business development strategy. This position may lead a small team and will report to the...potential impact. Deal Valuation NPV Modeling Financial Support: - Provide independent and high-quality financial support to all BDL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunities in cancer and specialty medicine.In close partnership with RD, provide expertise in the scientific assessment, therapeutic evaluation and feasibility ... the status of key opportunities and seek approval for advancing projects. Provide clear, concise assessments and recommendations for future reference. Fully leverage… more
- Genmab (Plainsboro, NJ)
- …like a fit? Then we would love to have you join us!The Role:The Director acts as a statistical expert supporting the clinical development of compounds as compound ... and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Director … more
- Genmab (Plainsboro, NJ)
- …our direct commercialization efforts, we are seeking a Global Physical Security Director to develop and implement a comprehensive security strategy that protects our ... travel security.Ensure compliance with local, national, and international security regulations. Lead crisis management planning and emergency response strategies, ensuring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …most diverse and collaborative groups within the organization. From health-care- provider interactions and developing and implementing regulatory strategies with the ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR...Are you ready to make a difference? The Position Lead the Medical Promotional Review staff and direct their… more
- Merck & Co. (Rahway, NJ)
- …to become the premier " Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA ... Commercial Data Solutions team and lead Digital Product...have been designated as "remote".The Company is required to provide a reasonable estimate of the salary range for… more
- Merck & Co. (Rahway, NJ)
- …products, as well as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...and enhanced robustness, regulatory, and compliance requirements of the company. Provide executive leadership and direction for the technical transfer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Scientific Global Medical Director will provide leadership, direction, and guidance for the development and ... execute global meetings plus support speakers in preparation for presentation of NN data at conferences and symposia Co- lead landscape assessment(s) to plan for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical Trials ... cluster representative for initiatives at all levels of the organization.Build and lead the team to effectively manage resources ensuring appropriately skilled and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn this Principal Scientist/ Director position within Translational Oncology, this team member will provide leadership for aligned and integrated ... Teams (ADTs) and our diagnostic partners.-Position reports to Executive Director , CDx. Primary Responsibilities : Direct CDx/IVD development projects, including… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Director , Medical Communication and Publications will be an essential leader and responsible ... strategy and activities across the Hematology portfolio. The individual will lead the Hematology medical communications and publications team and play an… more
