- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for ... areas for global teams as part of the Corporate Headquarters.- The Rahway EHS Director is a member of the Rahway Site Coordination team and collaborates with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or ... safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... new group within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage ... programs, in order to proactively perform safety surveillance and risk management in partnership... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical development plans, and addressing all regulatory, drug and patient safety , data, CMC, IP, patient selection, market access and and other relevant ... functions in support of the asset. Design, maintenance and update of the compound's Integrated Product Development Plans, Target Product Profiles and Target Product Claims, and presentation of product development plans and budget to internal review Boards.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports ... (AESI) educational materials. This role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Oncology Medical Affairs, Medical Intelligence is responsible for ... and portfolio level decision making eg provide intelligence on SOC evolution, safety and efficacy bars for practice changing treatments, information on novel/early… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …(CSL)- Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project ... statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions and… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST ... leader on study team; Responsible before senior management for the creation and execution of development strategies for program/s under IST; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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)
- Job DescriptionDirector, Chemical Biotechnologies Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in ... development of the scientists on their team to support these efforts.This Director drives scientific excellence and innovation to establish and maintain a… more
