- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to ... for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... and execution through RBQM activities. Accountable for the management, performance, and development , both technical and career, of direct reports, and mentors or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development ... patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads ... submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …governance modelLead training related risk analyses and escalate them to senior leadership in GQAResponsible for development , oversight, and maintenance ... cross functional GxP areas in the DS groupResponsible for the development of cross-functional training strategies Strategic roadmap including , infrastructure,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …evolution and implementation of training curriculum and workshops. In addition, the Associate Director will be involved in the development /training of field ... areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scope. This role will be supporting some functions within Research & Development .ResponsibilitiesResponsible for HRBP support for one or more sub-groups of the DSI ... with R&D leaders and HR center of excellence teams.In partnership with senior leaders, accountable for building a diverse talent pipeline for critical rolesProvides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance ... the value of our oncology pharmaceutical products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... to the highest quality standards. This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSI CSPV HR-related matters, including performance reviews and departmental talent development .Line management and senior leadership accountabilities in CoELead ... research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic… more
- Merck & Co. (Rahway, NJ)
- …medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical ... compounds.Support of business development assessments of external opportunitiesThe Senior Director May: Supervise the activities of Clinical Scientists… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... Implementation Services Lead plays a key role in overseeing the development , validation, implementation, and integration of GxP-regulated systems across the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productive work environment. This pivotal position will report directly to the Senior Director of Operations.Key Responsibilities Champion and lead the employee ... Strengthening Leadership Capabilities, celebrating Rewards and Recognition, fostering Employee Development , and enhancing Communications.Drive and transform the operations of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …support and alignment, to focus and lead cross-functional teams toward development and execution of cross-organizational strategic choices that optimize USO ... clear ambition and cultivates a culture of empowerment and accountability Lead development , implementation and assessment of USO Strategy Leads the 3-5-year USO… more
- Merck & Co. (Rahway, NJ)
- …other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive Director may supervise the activities of ... in their area of responsibility.To accomplish these goals, the Executive Director may:Author and/or oversee detailed development documents, presentations,… more
- Merck & Co. (Rahway, NJ)
- …a broad, comprehensive knowledge of statistics and its applications in clinical drug development . Primary Activities :Report to the Executive Director and Head ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs… more
