At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Senior Director, Clinical Safety Science is a key leadership role responsible for shaping and advancing global safety strategy across the product lifecycle-from early development through post-marketing. This position oversees a team of Safety Scientists who partner with Safety Physicians and cross-functional stakeholders to ensure proactive safety surveillance, benefit-risk assessment, and risk mitigation planning for a group of assets. The Senior Director plays a pivotal role in influencing safety governance, driving innovation in safety science, and ensuring regulatory and compliance excellence. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise. Job Description Responsibilities <ul><li>Strategic Safety Leadership: Provide scientific and strategic leadership for safety surveillance and risk management for a group of assets. Lead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries.</li><li>Team and Talent Development: Lead, mentor, and develop a high-performing team of safety scientists supporting a group of assets. Champion a culture of scientific rigor, continuous learning, and collaboration. Ensure strategic alignment of talent to pipeline priorities, provide performance feedback, and guide professional growth to build future leadership.</li><li>Innovation and Process Excellence: Maintain strong knowledge of the evolving safety science and regulatory landscape. Drive initiatives to enhance scientific methods, tools, and systems supporting safety surveillance and signal detection. Lead cross-functional and global projects to evolve safety science capabilities. Contribute to strategic planning and operating model design for CSPV.</li><li>Compliance and Quality Oversight: Ensure all safety deliverables by the scientist team meet internal quality standards and are compliant with GCP/GVP and relevant global regulations. Support audits and inspections, contribute to CAPA development, and foster a culture of quality and accountability. </li><li>Resource Planning: Partner with CSPV portfolio management and product leads to forecast resource needs for a group of assets and align capacity with business priorities. Leverage metrics to inform decision-making and improve operational efficiency.</li></ul> Qualifications Education Qualifications<ul><li>PharmD or PhD degree in relevant discipline required </li></ul>Experience Qualifications<ul><li>At least 10 years of experience in clinical development, medical affairs or clinical safety/post marketing safety in the pharmaceutical industry required</li><li>At least 5 years of experience in clinical safety/post marketing safety in the pharmaceutical industry preferred</li><li>At least 5 years of people management experience required</li><li>Experience in leading safety scientist teams in clinical studies, regulatory submissions, aggregate reports and post-marketing surveillance and risk management</li><li>Excellent communication, project management, writing and analytic skills</li><li>Demonstrated strong organizational leadership skills</li><li>Extensive knowledge of the latest technical and regulatory development </li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$242,700.00 - USD$404,500.00 Download Our Benefits Summary PDF

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Senior Director, Clinical Safety Scientist

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Senior Robotics Automation Engineer is a highly experienced technical leader responsible for advancing the design, integration, optimization, and long-term operational strategy of robotic and automated laboratory systems within the Smart Research Laboratory.<ul><li>This role requires deep expertise in laboratory automation, engineering principles, scientific workflows, and biopharma research operations, combined with the ability to influence technical direction, guide cross-functional decision-making, and mentor less experienced engineers and scientists.</li><li>This individual will play a critical role in shaping automation strategy, evaluating emerging technologies, translating scientific needs into scalable automation solutions, and ensuring that robotic systems deliver reliable, precise, and high-quality performance in support of advanced drug discovery and research innovation.</li><li>In addition to hands-on technical execution, the Senior Robotics Automation Engineer will provide strategic guidance on system architecture, workflow design, vendor selection, platform sustainability, risk mitigation, and continuous improvement of automated laboratory capabilities.</li><li>The role requires regular on-site presence due to the highly integrated, hands-on nature of laboratory robotics, instrumentation, scientific equipment, and automation workcell operations.</li></ul> Job Description Responsibilities <ul> <li>Lead the design, implementation, testing, optimization, and lifecycle management of complex robotic and automated laboratory workcells, including integrated hardware, software, instrumentation, scheduling, and control systems.</li> <li>Serve as a senior technical authority for laboratory automation platforms, providing expert guidance on system architecture, workflow design, equipment selection, integration strategy, operational scalability, and long-term platform reliability.</li> <li>Partner with scientific, engineering, informatics, facilities, IT, and operational stakeholders to translate complex research needs into robust, scalable, and sustainable automated solutions that improve laboratory productivity, data quality, reproducibility, and research throughput.</li> <li>Evaluate, integrate, configure, troubleshoot, and maintain advanced laboratory automation systems, including liquid handlers, dispensers, pipettors, plate movers, robotic arms, plate sealers and desealers, acoustic transfer devices, multimodal assay readers, incubators, storage systems, and related scientific instrumentation.</li> </ul> <ul> <li>Develop, review, and optimize automation methods using orchestration and instrument-control platforms such as Momentum, Venus, InstinctS, and related automation APIs, ensuring methods are reliable, maintainable, validated, and aligned with scientific requirements.</li> <li>Provide senior-level oversight for method development, hardware integration testing, system validation, risk assessment, troubleshooting, and performance optimization across automated laboratory workflows.</li> <li>Lead or significantly contribute to automation roadmap planning, technology assessments, vendor evaluations, equipment acquisition decisions, and strategic recommendations that shape the future capabilities of the Smart Research Laboratory.</li> <li>Collaborate with external vendors and internal stakeholders to implement advanced robotics capabilities, including motion planning, multi-axis actuation, control systems, autonomous mobile robotics, device communication, and integration of novel automation technologies.</li> </ul> <ul> <li>Guide the validation, deployment, and continuous improvement of Autonomous Mobile Robot systems and other emerging automation platforms, ensuring safe, reliable, and effective operation within a research laboratory environment.</li> <li>Mentor junior automation engineers, scientists, and cross-functional users by providing technical coaching, training, design review, troubleshooting support, and best-practice guidance for automated workflows and robotic systems.</li> <li>Establish and maintain high-quality technical documentation, including system designs, integration plans, validation records, risk assessments, maintenance procedures, troubleshooting guides, and workflow specifications.</li> <li>Lead complex problem-solving efforts in a fast-paced research environment, balancing immediate operational needs with long-term platform strategy, system sustainability, safety, and scientific impact.</li> <li>Drive continuous improvement initiatives that increase automation reliability, reduce operational bottlenecks, improve assay execution quality, and expand the organization's ability to adopt advanced automated research capabilities.</li> </ul> Qualifications Education Qualifications<ul><li>Bachelor&apos;s Degree in science, engineering, robotics, automation, computer science, life sciences or a related field required</li><li>Advanced degree (M.S. or Ph.D.) is preferred</li></ul>Experience Qualifications<ul><li>Requires 5-7 years of hands-on experience designing, integrating, programming, validating, maintaining, and optimizing automated laboratory equipment, robotic systems, or complex scientific instrumentation in a research or biopharma environment</li><li>Prior experience in biopharma, pharmaceutical, biotechnology, drug discovery, translational research, or advanced laboratory automation environment is required </li><li>Demonstrated ability to lead technically complex automation projects from concept through implementation, including requirements gathering, design evaluation, vendor coordination, installation, integration, testing, validation, documentation, user training, and operational handoff. </li><li>Advanced experience with laboratory automation platforms and orchestration software such as Hamilton Venus, Thermo Scientific Momentum, InstinctS, or comparable automation-control environments.</li><li>Strong working knowledge of laboratory robotics, instrument communication, scheduling systems, device APIs, mechanical and electrical integration, liquid handling principles, assay workflow automation, and system-level troubleshooting.</li><li>Experience developing or supporting software tools, scripts, APIs, or applications using modern programming languages such as Python, Java, C#, or comparable languages to improve automation performance, data handling, system monitoring, or workflow control.</li><li>Proven ability to partner with scientific teams to identify high-value automation opportunities, evaluate technical feasibility, define requirements, and deliver solutions that support research quality, throughput, reproducibility, and innovation.</li><li>Experience influencing technical decisions, guiding platform strategy, mentoring colleagues, and providing senior-level recommendations to scientific, operational, and leadership stakeholders. </li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$136,080.00 - USD$204,120.00 Download Our Benefits Summary PDF

Senior Robotics Automation Engineer

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). Job Description Responsibilities Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan. Distribute key study documents to the CRO and vendors as appropriate. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Support Fair Market Value process in evaluating study budgets Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov). Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor. Compile and maintain a monitoring review spreadsheet. Compile and maintain CRO Oversight Monitoring (CROOM) visit output Analyze study site metrics reports to identify potential areas of concern and bring to supervisor's attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices). Works with Insurance Brokers to obtain study site Insurance Provide tracking and oversight to the Vendor handling lab logistics and any other vendors deemed appropriate. Participate in training; make recommendations for areas of improvement and innovation (study, or departmental level). Work with supervisor to provide input into individual career development plan. Responsibilities Continued Qualifications Education Qualifications Bachelor&apos;s Degree (preferred in Life Sciences) with relevant clinical development experience required Experience Qualifications 2 or more years work experience with Bachelors degree required Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience preferred Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred Travel Requirements Ability to travel up to 5% of the time. In-house office position that may require occasional travel. Additional Information Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$100,960.00 - USD$151,440.00 Download Our Benefits Summary PDF

Sr Clinical Study Assoc CO

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