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

• 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.

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

• 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

• 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

• Provide strategic leadership for CDx development and commercialization
• Oversee execution of strategies in collaboration with cross-functional teams
• Develop and direct CDx/IVD strategic approaches
• Lead cross-functional CDx Teams for various assets/biomarkers
• Partner with internal stakeholders to develop CDx strategies
• Drive CDx partner/platform assessment and selection
• Serve as a subject matter expert within the company
• Participate in meetings with global regulatory agencies to provide CDx expertise
• Oversee transfer of assays from in-house efforts to Dx companies
• Evaluate relevant new technologies

Senior Principal Scientist – Senior Director, Companion Diagnostics

• 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 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
• serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Associate Principal Scientist, Statistical Programming – Late-Stage, Infectious Disease

• Provide technical support to the External Manufacturing Organization and (ExM) Contract Manufacturing Organizations (CMOs) as a team leader or individual contributor.
• Ensure the transfer of robust manufacturing processes to internal site and/ or CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO.
• Ensure robust process performance at CMO during commercial manufacture by using continuous process verification, Operational Excellence (OPEX), etc. to reduce supply risks.
• Support CMO/vendor selection process and/or internal site selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Requests for Information (RFIs) and Request for Proposal (RFPs).
• Accountable for technology transfer to contract manufacturing organizations.
• Support regulatory activities associated with changes to assigned products.
• Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply – metrics review, investigation close-out, change control review, Annual Product Quality Review (APQR) review, process improvement.
• Implement / OPEX initiatives as necessary.
• Communicating output of product performance reviews with VPT and other groups as required.

Principal Scientist, Drug Product Development – Pharma MS&T

• This position has primary responsibility for planning/managing a comprehensive program of real-world evidence and non-interventional research activities for in-line and pipeline products for lung cancers to meet the value evidence needs of clinicians, payers, policymakers, health technology assessment (HTA)/reimbursement agencies, and health systems globally.
• Critically assess drivers and barriers to reimbursement and market access in collaboration with internal teams, and provide input into clinical, payer/access, marketing and value evidence generation strategies and programs.
• In collaboration with internal teams and external partners, design non-interventional and data synthesis 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, budgets, and vendor/partner management.
• Develop American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.
• Develop supplementary clinical data package for submission to Health Technology Assessment (HTA) agencies in close partnership with country affiliates and HTA statistics group.
• 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 partnerships with scientific experts worldwide.
• Present outcomes research data at national and international congresses and publish articles in scientific journals.

• Serve as a primary technical resource for glass and related critical components, applying deep materials science knowledge to characterize component performance and failure modes
• Lead root-cause investigations into glass breakage, handling, and other component-related events; develop evidence-based corrective and preventive actions
• Define material and component specifications, acceptance criteria, and test strategies aligned to product use and regulatory expectations
• Lead and execute qualification packages for new components, including feasibility studies, performance testing, compatibility considerations, and documentation to demonstrate fitness for use
• Develop process control strategies and acceptance criteria for suppliers and manufacturing, using data-driven methods (DOE, SPC, capability studies) to characterize risk and variation
• Collaborate with suppliers to assess technical capability, resolve quality or performance issues, review supplier change controls, and implement supplier improvement plans
• Work closely with Quality and Regulatory Affairs to ensure component specifications, testing strategies, and documentation meet applicable standards and guidance (e.g., USP, ISO, FDA)

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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

Senior Principal Scientist, Translational Clinical Biomarkers

Associate Principal Scientist, Human Factors

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

Principal Scientist – Regulatory Affairs, CMC

Associate Principal Scientist, Statistical Programming, Late-Stage

Senior Principal Scientist – Senior Director, Companion Diagnostics

Associate Principal Scientist, Statistical Programming – Late-Stage, Infectious Disease

Principal Scientist, Drug Product Development – Pharma MS&T

Principal Scientist – Outcomes Research

Associate Principal Scientist, Glass & Critical Components, Device Development and Technology