Research Scientist

• Set technical direction for core replenishment R&amp;D.
• Model complex problems such as inventory decay, promotions, price elasticity, and inventory uncertainty.
• Drive fundamental changes to our core system from research through production.
• Lead research and development for new product and business challenges.
• Mentor scientists and engineers, set standards for experimental rigor.

Staff Applied Scientist

• developing, maintaining, and implementing Core Labeling and target labeling for assigned products in line with internal standards and guidelines
• Developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
• Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
• Providing labeling expertise and guidance to teams, assimilating labeling precedence and competitor labeling, while ensuring compliance with applicable regulatory requirements
• Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products
• Leading (both direct reports and cross-functional teams) to develop, review and approve Core and Local Labeling documents
• Independently recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority
• Providing information to Global Labeling Compliance, as required, to support internal and external (i.e., Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
• Evaluating risks associated with Core or Local Labeling content, developing mitigation strategies, and appropriately escalating issues to Global Labeling management and the Global Regulatory team
• Proficiency in crucial labeling requirements worldwide
• Contributing to the continuous improvements to the end-to-end labeling process, including labeling policies, procedures, quality, and system tools
• Providing guidance, coaching, training and may provide management support to other Global Labeling Leads

Principal Scientist – Global Labeling Lead

• Lead a team in the development and execution of health economic and modeling strategies to support the value of the Company’s oncology portfolio
• Provide leadership, mentorship, and strategic direction to a team of 3–4 health economists
• Oversee the prioritization and development of high-quality global health economic models and tools to support market access, pricing, reimbursement, HTA submissions, and formulary decision-making across U.S. and international markets
• Collaborate with key countries and the regional team to adapt global models for local HTA, reimbursement, and formulary submissions
• Generate and communicate early health economic insights to inform development and commercialization strategies
• Build strong partnerships with internal stakeholders to ensure modeling strategies align and support the overall product development and value evidence strategy and implementation
• Develop and maintain relationships with external thought leaders in health economics, decision sciences, and health policy to enhance scientific credibility, inform strategy, and position our company as a leader in the field

Senior Principal Scientist, Outcomes Research

• Independently build, align, and execute technical plans to achieve objectives across multiple programs
• Timely delivery of hands-on data analysis, visualization, and interpretation for Discovery portfolio decision-making
• Substantially impact Discovery programs through direct technical execution and indirect contribution as a member of Discovery project teams
• Collaborate with cross-functional teams to drive computational insights for Discovery programs

Principal Scientist, Computational-Immunology Discovery

• Leading the development, optimization, and validation of spatial genomics and molecular profiling assays to support neuroscience, oncology, and immunology programs.
• Designing and executing experimental workflows involving tissue processing, immunohistochemistry, in situ hybridization, microscopy, high‑resolution slide imaging and sequencing.
• Establishing and refining new molecular assays, including troubleshooting, workflow development, and technical feasibility assessments.
• Building and scaling laboratory infrastructure, including lab setup, instrumentation planning, and operational readiness.
• Managing CROs and external partners, ensuring high‑quality data generation, timeline alignment, and technical deliverables.
• Collaborating closely with therapeutic area teams to translate multiomics and spatial readouts into actionable biological insights.
• Contributing to data workflows by supporting early-stage data mapping, QC frameworks, and analytical handoffs to computational teams.

Principal Scientist, Spatial Omics

• Under the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for planning/managing real world and economic evidence activities for in-line and pipeline products to meet the value evidence needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally.
• Types of studies executed include prospective and retrospective observational studies.
• Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions.
• The incumbent is expected to work cross-functionally with clinical development, medical affairs, biostatistics, market access, commercial and country affiliates.
• The incumbent may supervise external vendors or partners to execute these activities.

Associate Principal Scientist – Outcomes Research

• Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes
• Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization
• Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution
• Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements
• Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation
• Author regulatory and technical documentation, ensuring all processes align with our company’s expectations
• Manage a small team of junior staff, guiding them in their professional development

Associate Principal Scientist, Biologics Drug Substance Commercialization – Associate Director

• Assist a Medical Ethics and Health Policy Professor and his Research team with development of AI tools
• Testing AI protocols
• Preparing materials for meetings
• Organizing and synthesizing data
• Supporting project coordination activities

Temporary Research Assistant

• support statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects
• development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures)
• design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
• key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables
• statistical programming point of contact and knowledge holder through the entire product lifecycle
• assurance of deliverable quality and process compliance
• effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model
• coordinating the activities of a global programming team that includes outsource provider staff.

Associate Principal Scientist, Statistical Programming, Late-Stage

• Develop and maintain high-quality global health economic models and tools, either in-house or in collaboration with external partners, to generate business insights and demonstrate product value.
• Provide insights into the development and refinement of the integrated value evidence strategy from a health economics perspective.
• Collaborate with internal and external stakeholders to generate and synthesise evidence that informs economic models and value strategy.
• Support the adaptation and/or training of global health economic resources for HEDS Regional and local HEOR teams to enable HTA submissions and market access activities.
• Disseminate health economic evidence through presentations at national and international congresses and publications in peer-reviewed journals.

Associate Principal Scientist, Health Economics

• supports statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects
• development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures)
• design and maintenance of statistical databases that support multiple stakeholder groups
• assurance of deliverable quality and process compliance
• development utilizing global and TA standards that optimize analysis and reporting
• coordinating the activities of a global programming team
• membership on departmental strategic initiative project teams

Assoc. Principal Scientist, Statistical Programming – Late-Stage, Infectious Disease

• Lead in value evidence teams in Women’s Cancer and contribute to value evidence strategies.
• Obtain senior management approval of evidence generation plans.
• Provide outcomes research leadership on cross-functional regional and global teams.
• Critically assess drivers and barriers to reimbursement and market access, and provide input into clinical, regulatory, payer/access, marketing and evidence generation strategies and programs.
• In collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.
• Responsible for study-related contracting, and budgets.
• Develop supplementary clinical data package in close partnership with markets and HTA statistics group for submission to HTA agencies.
• Support country affiliates to understand local evidence generation needs, adapt health economic evaluations, customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements.
• Work closely with cross functional teams to effectively communicate outcomes research and health economic modelling data internally and to external stakeholders.
• Maintain awareness of new scientific and methodological developments within therapeutic area.
• Build relationships with scientific experts worldwide.
• Present outcomes research data at national and international congresses and publish articles in scientific journals.

Principal Scientist – Outcomes Research

• Provide strategic and scientific leadership in the design, execution, analysis, and communication of clinical biomarker strategies across immune-mediated therapeutic portfolio
• Drive decision-centric biomarker strategies that connect drug mechanism, disease biology, precision medicine
• Lead and shape integrated biomarker strategies across discovery, early- and late-stage clinical programs
• Serve as the biomarker strategy lead within cross-functional program teams
• Inform portfolio strategy by advancing biomarker-driven insights
• Translate disease biology into clinically actionable biomarker strategies
• Drive selection and application of innovative biomarker approaches
• Collaborate effectively across disciplines to integrate scientific perspectives into cohesive strategies
• Champion biomarker analysis plans and provide critical scientific input to interpretation of complex datasets

Senior Principal Scientist, Translational Clinical Biomarkers

• Lead Human Factors Project Work (Execution and Strategy), including, but not limited to: Establish and own HF strategy from early concept through validation and post-market for devices and combination products
• Build HF plans and study roadmaps; select methods (user research, task/use-error analysis, risk mitigation, formative/summative usability testing)
• Turn user insights into design inputs for device UI, packaging, labeling, and IFU; guide intuitive, safe designs
• Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF and manage risk
• Lead regulatory deliverables: HF protocols/reports, linkage to risk management (ISO 14971), hazard/use-related risk analyses, and submission materials (FDA, EU MDR)
• Maintain and manage compliant HF documentation and traceability; ensure audit readiness
• Monitor post-market use-related issues and drive corrective actions and training
• Define and continuously improve HF process, standards, and templates per IEC 62366-1 and FDA guidance
• Create reusable platform methods for needs discovery, user profiling, task analysis, and use-related risk assessment
• Provide portfolio-level guidance for UI, labeling, and IFU to reduce use-related risk
• Train cross-functional teams on HF practices and compliant documentation
• Establish metrics and feedback loops (study quality, defects, post-market signals) to prioritize improvements
• Maintain centralized HF libraries and tools to enable reuse and speed development
• Stay up-to-date with the latest advancements in human factors within the regulatory and industry landscape, and have the ability to represent our company in external communities and exert influence

Associate Principal Scientist, Human Factors

• Develop and apply state‑of‑the‑art AI/ML, statistical, and computational frameworks to analyze genomics, transcriptomics, proteomics, metabolomics, single‑cell, and multi‑omics datasets.
• Lead the design and execution of spatial omics analyses at massive scale, integrating imaging‑based, sequencing‑based, and multiplexed spatial platforms to uncover tissue architecture, cellular neighborhoods, and microenvironmental dynamics.
• Build scalable pipelines to preprocess, QC, harmonize, and integrate terabyte‑ to petabyte‑scale spatial omics datasets, enabling discovery‑ready data layers and advanced modeling.
• Deploy, adapt and develop agent‑based models (ABM) to simulate cellular interactions, tissue‑level organization, and dynamic biological processes, incorporating outputs from multimodal omics and spatial measurements.
• Fuse mechanistic models with ML/AI frameworks to generate hybrid predictive systems for target discovery, perturbation response, and disease progression modeling.
• Deploy and create novel ML architectures, including deep learning, generative models, graph neural networks, and causal inference frameworks that are tailored for biological complexity.
• Design and implement scalable algorithms for high‑dimensional, multimodal integration of spatial, molecular, and phenotypic data.
• Prototype and benchmark cutting‑edge computational approaches, pushing the frontier of in silico biological inference.
• Map, influence, and guide the development of computational and data architecture needed to support next‑generation omics and ML workloads.
• Partner with data engineering and platform teams to define standards for data ingestion, modeling workflows, metadata management, and reproducible research ecosystems.
• Ensure infrastructure supports large‑scale distributed training, complex spatial analytics, cloud‑native computation, and long‑term model governance.
• Act as a senior scientific authority, shaping strategy and guiding decision‑making across discovery and platform innovation, without direct people management.
• Provide high‑level technical mentorship, scientific critique, and modeling guidance to colleagues and collaborators.
• Drive cross‑disciplinary project teams by defining computational strategy, interpreting results, and ensuring scientific rigor.
• Deliver insights that advance target identification, mechanism‑of‑action exploration, pathway modeling, biomarker discovery, and patient stratification.
• Translate computational discoveries into actionable biological hypotheses, experimental designs, and portfolio‑impacting recommendations.
• Communicate findings effectively to scientific and strategic stakeholders.

Senior Principal Scientist, Spatial Omics

• Support the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas.
• Adheres to standard operating procedures and guidelines established by the department.
• Drives data structures that include analysis and reporting data standards and submission standards.
• Actively leads and contributes to the department's strategic initiatives.
• Key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.
• Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.
• Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.
• Facilitate global adoption of standards and programming best practices.
• Provide technical consultation and analytical support to statistical programmers and statisticians.
• Lead and actively contribute to departmental strategic initiative project teams.

Principal Scientist, Statistical Programming – A&R Standards, Innovation

• Work with APLs to develop and implement the commercialization analytical strategy across testing nodes.
• Participate in significant investigations across the viral vaccines franchise.
• Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
• In partnership with the AWG and network QC labs, support definition of the opportunities for improvement/investment in equipment and technology required to drive assay modernization and implement harmonized network solutions.
• This includes working with our Digital manufacturing Division and LMAS team for assay digitization with harmonized data capture.
• In partnership with the BCR hub, develop short and mid-term strategy for sustainability in BCR inventory and antisera generation needed to support all testing laboratories in the network and connect BCR performance with assay performance as noted above.
• Provide SME support to APLC gap assessments of key methods to drive improved and sustainable robustness.
• Ensure method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate.
• Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply
• Escalate key assay challenges to management in a timely and concise manner.
• Support RTQs, PAI readiness and audit observations

Associate Principal Scientist, Analytical R&D

• Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products.
• This includes preparation of applicable IND/CTA’s, Agency Background Packages, Worldwide Marketing Applications (including Most of World applications), and transfer strategy to post-approval grp. for further submissions occurring within several years post-launch in the major markets.
• This role may also directly support a project in a similar capacity; however, the primary focus of the position is providing direction to the team members that are responsible for developing and overseeing implementation of regulatory strategies, and making decisions that ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions.
• This includes assessing CMC changes during development, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment.
• Be responsible for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.
• Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges.
• Drive the application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Senior Leadership in these areas.
• Embody our Company's Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.
• Continuously evaluate and develop talent within the team and prepare a succession plan.
• Use recognition and rewards to promote team and organizational collaboration.
• Set a vision for the team and hold employees accountable for the execution of departmental policies and procedures.
• Manage resources and prioritization within assigned areas.
• Actively sponsor employees who lead and participate in our Company's initiatives.
• Develop strong collaborative relationships with stakeholders and partners across the organization.
• Represent the department’s needs and positions in senior leadership forums.
• Develop and maintain expert knowledge of current global regulatory CMC requirements for IND/CTA submissions, and original registrations.
• Identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making; collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills.

Principal Scientist – Regulatory Affairs, CMC

• support statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects
• development and execution of statistical analysis and reporting deliverables
• design and maintenance of statistical databases
• key collaborator with statistics and other project stakeholders
• assure deliverable quality and process compliance
• maintain and manage a project plan including resource forecasting
• coordinate activities of a global programming team
• membership on departmental strategic initiative project teams

See all jobs on JobTailor

Staff Applied Scientist

Principal Scientist – Global Labeling Lead

Senior Principal Scientist, Outcomes Research

Principal Scientist, Computational-Immunology Discovery

Principal Scientist, Computational-Immunology Discovery

Principal Scientist, Spatial Omics

Associate Principal Scientist – Outcomes Research

Associate Principal Scientist, Biologics Drug Substance Commercialization – Associate Director

Temporary Research Assistant

Associate Principal Scientist, Statistical Programming, Late-Stage

Associate Principal Scientist, Health Economics

Assoc. Principal Scientist, Statistical Programming – Late-Stage, Infectious Disease

Principal Scientist – Outcomes Research

Senior Principal Scientist, Translational Clinical Biomarkers

Associate Principal Scientist, Human Factors

Senior Principal Scientist, Spatial Omics

Principal Scientist, Statistical Programming – A&R Standards, Innovation

Associate Principal Scientist, Analytical R&D

Principal Scientist – Regulatory Affairs, CMC

Associate Principal Scientist, Statistical Programming, Late-Stage