Research Scientist

• Provide high-quality clinical care and accurate record keeping for all laboratory animals, including clinical assessment and diagnoses, treatment planning, management of disease outbreaks, and performance of surgery and anesthesia
• Serve as a clinical veterinarian at the LVL site, with cross-coverage responsibilities at the NBR site as needed, including veterinary oversight for GLP studies and ensuring compliance with applicable GLP regulations and standards
• Direct and evaluate animal health surveillance programs; interpret and apply microbiological, serological, and parasitological data to prevent, diagnose, and treat laboratory animal disease
• Collaborate with scientific staff on experimental protocol design and animal model development, building expertise in translational research models
• Partner with the VS Global Training Team to implement and deliver training programs for VS staff and research personnel, supporting compliance with all applicable regulations and standards
• Support the IACUC through rotational veterinary pre-review of all activities involving animals, post-approval monitoring (PAM), and assessment of research personnel technical competencies
• Contribute to internal projects and cross-site committees, with opportunities to take on increasing responsibility over time
• Supervise VS staff as assigned, with mentorship provided
• Provide veterinary care and oversight for a diverse range of species, including, but not limited to, rodents, canines, rabbits, swine, and nonhuman primates (NHP).

Principal Scientist, Staff Veterinarian

• The Senior Principal Scientist will serve as a CMC Analytical Lead (CMC-AL) for drug candidates across all stages of development, as well as within the commercial product portfolio as needed.
• Collaborate across functions to identify critical quality attributes (CQAs) for drug substance and drug product and establish control strategies to ensure product quality.
• Drive analytical controls in alignment with ICH guidelines and global regulatory requirements.
• Lead analytical strategy development as a core member of cross-functional CMC teams.
• Define product critical quality attributes and establish methods, specifications, and analytical control strategies.
• Collaborate across Analytical, Drug Substance, Drug Product, Quality, and Regulatory functions.
• Review, interpret, and communicate analytical results and conclusions.
• Author, review, and approve technical reports to support regulatory submissions.
• Respond to regulatory authority questions related to analytical strategy and data.
• Provide leadership, coaching, and mentoring to scientific staff within matrix teams.

Senior Principal Scientist, Analytical Chemistry

• Partner cross-functionally with the Value Chain Team (VCT) and manufacturing sites owning the coordination of technical activities to ensure manufacturing and supply demands are met
• Lead and Execution of technical projects that will enhance manufacturing output through optimization and harmonization across production sites
• Your efforts will have a direct impact on patient supply!
• Lead improvement and innovation initiatives includes building project business case; partner with R&Dsite functions and finance to identify COGS improvement opportunities (COGS optimization process)
• Author, review and approval of product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.)
• Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans
• Act as Process SME: proactively monitor technical process and product performance to detect trends and develop mitigation plans
• Maintain a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management and tech transfers for product

MSAT Principal Scientist

• Collaborate with passionate problem solvers
• Innovate as a team to help customers achieve their goals
• Provide valuable benefits and a quality-of-life balance
• Recognize our people by providing valuable benefits

Principal Research Scientist

• Set technical direction for core replenishment R&D — define the modeling roadmap across demand forecasting, inventory optimization, and decision-making policy, and align it with product and business strategy.
• Model complex problems such as inventory decay, promotions, price elasticity, and inventory uncertainty, and implement solutions to multi-stage and multi-echelon inventory optimization problems.
• Drive fundamental changes to our core system from research through production, writing rigorously tested and scalable code.
• Lead research and development for new product and business challenges.
• Raise the technical bar across the Intelligence team: mentor scientists and engineers, set standards for experimental rigor, and review designs and results.
• Push the boundaries of AI capabilities in both products and scientist workflows.

Staff Applied Scientist – Distribution Center

• Lead end-to-end AI applications on trial imaging data (CT, MRI, PET) for quantitative imaging measures and AI-derived endpoints
• Collaborate internally and externally to drive scientific innovation in foundational imaging AI that are relevant to oncology drug development — including automated segmentation, radiomics, and multimodal predictive modeling through hands-on research
• Translate imaging-derived evidence into actionable insights by converting complex quantitative findings into clear scientific narratives and engaging cross-functional stakeholders
• Provide scientific leadership to external partnerships — including imaging AI vendors, CROs, biomarker companies, academic centers, and imaging OEMs — to accelerate model development, validation, and deployment
• Publish and present scientific innovation at top scientific and clinical conferences (e.g., MICCAI, AACR, RSNA, etc.)

Principal Scientist, Imaging Analytics

• Lead end-to-end AI applications on trial imaging data (CT, MRI, PET) for quantitative imaging measures and AI-derived endpoints.
• Collaborate internally and externally to drive scientific innovation in foundational imaging AI that are relevant to oncology drug development — including automated segmentation, radiomics, and multimodal predictive modeling through hands-on research.
• Translate imaging-derived evidence into actionable insights by converting complex quantitative findings into clear scientific narratives and engaging cross-functional stakeholders.
• Provide scientific leadership to external partnerships — including imaging AI vendors, CROs, biomarker companies, academic centers, and imaging OEMs — to accelerate model development, validation, and deployment.
• Publish and present scientific innovation at top scientific and clinical conferences (e.g., MICCAI, AACR, RSNA, etc.)

• Leads value evidence teams and develops value evidence strategies for in-line and pipeline products.
• Obtains senior management approval of evidence generation plans.
• Provides outcomes research leadership on cross-functional regional and global teams.
• Critically assesses drivers and barriers to reimbursement and market access, and provides input into clinical, regulatory, payer/access, marketing and evidence generation strategies and programs.
• In collaboration with internal teams and external partners, designs studies, authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.
• Responsible for study-related contracting, budgets, and vendor/partner management and to ensure study conduct is aligned with company Policies and SOPs and world-wide regulations and standards, including Good Pharmacoepidemiology Practice (GPP) for applicable work.
• Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their local HTA submissions.
• Develops supplementary clinical data package in close partnership with markets and HTA statistics group for submission to HTA agencies.
• Supports country affiliates to understand local evidence generation needs, adapts health economic evaluations, customizes outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements.
• Works closely with cross-functional teams to effectively communicate outcomes research and health economic modelling data internally and to external stakeholders.
• Maintains awareness of new scientific and methodological developments within therapeutic area.
• Builds relationships with scientific experts worldwide.
• Presents outcomes research data at national and international congresses and publishes articles in scientific journals.

Principal Scientist – Rheumatology Outcomes Research

• Support local adaptation of global Health Economics Models in Asia-Pacific, Eastern Europe, Middle East, Africa, Latin America, and Mid-Europe Region.
• Collaborate with internal and external partners to enable patient access and quantify the value of products.
• Conduct or supervise health economic model adaptations ensuring quality and alignment with market needs.
• Provide input to stakeholders on health economic modeling activities and share learnings across regions.
• Coordinate activities between regions and communicate impact to senior management.

Associate Principal Scientist, Health Economic and Decision Sciences

• Design and execute mixed-method research studies (surveys, interviews, usability testing, field observations, diary studies, etc.) that adhere to best practices
• Conduct foundational research to understand user behaviors, needs, and motivations
• Lead the recruiting of diverse, representative participant samples
• Select and manage research vendors to ensure study outputs meet team and stakeholder expectations
• Analyze research data to identify patterns and actionable insights; synthesize findings into clear, decision-ready reports and presentations
• Create customer journey maps, personas, use scenarios, and other synthetic frameworks that enable team members to understand customer needs, behaviors, and wants
• Scope experience opportunities, conduct benchmarking, and frame CX/UX problems to inform digital experience strategies
• Support strategy activation by defining MVP experiences and prioritizing initiatives for implementation
• Present findings and strategic recommendations in a compelling, storytelling manner to internal audiences, including senior leadership
• Facilitate workshops, ideation sessions, and empathy exercises to build group consensus and enable evidence-based decision making
• Collaborate cross-functionally with designers, product owners, and other internal stakeholders to integrate research findings into product and experience decisions

Senior Digital Consumer Experience Researcher

• 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

• 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

• Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement.
• Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable
• Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
• Prepares and delivers internal and external translational/biomarker presentations
• Maintains timelines for biomarker data related publication through interaction with Medical Communications and Publication team as needed
• Keeps up-to-date on relevant scientific/technical literature in order to applying external knowledge to internal research programs as appropriate and acts as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
• Works with TM laboratory scientists and academic TLs to address nonclinical translational questions
• Participates in post-hoc biomarker analysis and publication efforts
• Supports regulatory submissions and regulatory interactions as needed

Senior Principal Scientist, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine

• Lead the development of amorphous solid dispersions (ASD) and solubility-enhanced oral dosage forms using hot melt extrusion (HME) and spray drying as the primary technology platforms, from preclinical concept through clinical and commercial formulation.
• Apply expertise in solid oral dosage form development — encompassing formulation design, process development, scale-up, and technology transfer — across preclinical, clinical, and commercial stages.
• Define pilot plant batch manufacturing requirements, oversee study execution, and provide technical consultation during clinical and commercial batch manufacture.
• Collaborate with the preformulation team to characterize materials using DSC, TGA, XRPD, SEM, and hot-stage microscopy; interpret data and apply findings to formulation strategy.
• Author high-quality GDP-compliant technical documents including development reports, technical specifications, project risk assessments, and regulatory CMC submissions in accordance with applicable guidance and site SOPs.
• Design and interpret experiments using statistical analysis, design of experiments (DoE), and data visualization tools to support robust development decisions.
• Plan and organize assigned work across multiple concurrent projects, prioritizing effectively to meet scientific, regulatory, and client timelines.
• Develop formulation strategies and lifecycle plans that align with regulatory requirements and client objectives.
• Proactively acquire and apply new scientific principles and technologies with minimal direction.
• Ensure compliance with Health, Safety, and Environmental requirements; maintain current training records for all required procedures.
• Contribute to the training and mentoring of junior R&D personnel as required.
• Communicate scientific findings clearly and persuasively in written and verbal formats to both internal teams and external clients.
• Manage difficult client discussions constructively, guiding conversations toward acceptable resolutions.
• Enhance Ardena’s scientific visibility through publications, webinars, conference presentations, and symposia.
• Support departmental goals by delivering high-quality technical work and maintaining strong client relationships.
• Identify and recommend emerging technologies with potential application to Ardena’s solubility enhancement service offerings.
• Understand the structure and content requirements of CMC regulatory filing packages; author and review formulation and analytical sections of regulatory submissions.
• Publish or present research findings internally and externally to advance scientific knowledge and Ardena’s profile.

Principal Scientist – Solubility Enhancement Technologies

• 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

• 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.

Research Scientist jobs in New Jersey

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Principal Scientist, Staff Veterinarian

Senior Principal Scientist, Analytical Chemistry

MSAT Principal Scientist

Principal Research Scientist

Staff Applied Scientist – Distribution Center

Principal Scientist, Imaging Analytics

Principal Scientist, Imaging Analytics

Principal Scientist – Rheumatology Outcomes Research

Associate Principal Scientist, Health Economic and Decision Sciences

Senior Digital Consumer Experience Researcher

Staff Applied Scientist

Principal Scientist – Global Labeling Lead

Senior Principal Scientist, Outcomes Research

Associate Principal Scientist – Outcomes Research

Associate Principal Scientist, Biologics Drug Substance Commercialization – Associate Director

Senior Principal Scientist, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine

Principal Scientist – Solubility Enhancement Technologies

Associate Principal Scientist, Statistical Programming, Late-Stage

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

Principal Scientist – Outcomes Research