- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including study design,… more
- Merck & Co. (Rahway, NJ)
- …Critically, the Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have GMP facility operations ... skills.The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply.- Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, ... person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... as well as alliance partners, promoting a cohesive team approach.Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …improvement of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing ... and beyond in post approval setting.Responsible for the execution of key safety initiatives aimed at preventing, mitigating, and addressing critical safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management.Develop a strong, positive strategic business partnership with the global R&D business functions of Daiichi Sankyo. As a trusted partner, provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a trusted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers.- CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study… more
- Merck & Co. (Rahway, NJ)
- …talented and dedicated colleagues while developing and expanding your career.--The Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
