Clinical Operations

• Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s)
• Serving as the lead clinical scientist on the clinical trial team
• Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director
• Collaborating cross-functionally in the development of Protocol and related study materials
• Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Providing tactical/scientific mentorship to other clinical scientists

Senior Scientist, Clinical Operations

Research Scientist

• 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.
• Critically assesses drivers and barriers to reimbursement and market access, providing input into clinical, regulatory, payer/access, marketing and evidence generation strategy 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.
• Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.
• Works closely with cross-functional teams to effectively communicate outcomes research and health economic modelling data internally and to external customers.

Associate Principal Scientist – Outcomes Research

Sales

• Our Hybrid Sales team supports our customers by providing clinical information about products, educational information, clinical training programs, and resources
• The PVAR is responsible for engaging with assigned customers (i.e., pharmacy, medical groups, physician offices) in a way that supports the local market focus on population health and centers on the highest potential business opportunities with these customers that will improve our impact on public health
• They will work with the local market team to understand and identify customer needs, proactively align products and services, support pull-through activities relative to integrated strategies, and ensure that our Company is viewed as demonstrating value and better health outcomes to healthcare professionals and their patients
• The PVAR is responsible for ensuring all activities adhere to the spirit and letter of all Company Policies and US Laws and Regulations
• The PVAR reports to the Customer Team Leader (CTL), Vaccine Customer Center, and works in close collaboration with broader Vaccine Field Sales team
• This position is a hybrid sales position with ~50% of the engagements with HCPs occurring remotely and ~50% requiring travel for the purpose of live customer engagements, exhibits, internal/external company meetings and relevant vaccine business activities
• Typical hours of operation are 8AM - 5PM EST, Monday - Friday, adjusting hours aligned to the geographical time zone based on residence

Senior Customer Representative, Telesales

Director

• Plans and conducts confidential investigations of potential corporate policy violations; identifies and conducts interviews with all relevant involved parties; gathers and reviews relevant documentation; analyzes all evidence and draws factual findings and conclusions
• Supports triaging of allegations, including assessing allegations at intake to determine whether a potential policy violation exists and/or directing the reporting person to appropriate party (such as HR or management) for follow-up
• Makes recommendations on discipline for individuals and on potential corrective and preventive actions for the organization, and manages the remediation process with stakeholders in Legal, Human Resources, Compliance, and Management
• Drafts detailed case reports summarizing the investigation, factual findings, and remediation
• Assists the Director in identifying and reporting investigation trends to senior leadership
• Works with stakeholders across the organization and geographic locations when required
• Works closely with divisional Compliance to investigate potential compliance-specific policy violations
• Supports divisional Compliance with the identification of investigation trends and with drafting various reports, including but not limited to the Audit Committee Report
• Attends and participates in divisional Compliance meetings

Associate Director, Global Investigations

• Under the guidance of a senior leader, has primary responsibility for developing value evidence strategies
• Planning/managing real world and economic evidence activities
• Types of studies executed include prospective and retrospective observational studies
• Development of American Managed Care Pharmacy (AMCP) dossiers for US payers
• Expected to contribute to product development and marketing strategies throughout the lifecycle
• Works cross-functionally with clinical development, medical affairs, biostatistics, market access, commercial and country affiliates

Principal Scientist – Outcomes Research

Compliance

• In this role, you will have the opportunity to coordinate regulatory activities in the EU, UK, Switzerland, and non-EU SEE countries.
• Responsible for implementing strategies for products in development with guidance and independently developing and executing strategies for registered products.
• Play a crucial role in managing submissions and interactions with the EU regulatory agencies.
• Liaise with HQ US-based cross-functional teams, effectively communicating regional requirements and ensuring compliance with all necessary regulations for assigned projects.
• Coordinate or oversee the preparation of regulatory documentation in a timely manner, aligning with corporate objectives.

Regulatory Liaison Manager

Procurement

• Lead the global category strategy for specialty chemicals, reagents and solvents
• Manage all related contracts for these direct materials
• Identify and deliver savings targets and manage risk to ensure uninterrupted supply of materials
• Collaborate with regional and site category leads to implement strategies at site level
• Lead global sourcing and supplier management
• Manage key supplier relationships, including regular business reviews and strategic meetings
• Oversee the global sourcing process to ensure assurance of supply, cost effectiveness, innovation, sustainability, social responsibility and compliance
• Partner with research and development and other ingredients teams to maintain an end‑to‑end view of the supply base
• Achieve cost control, reduction and containment objectives using a total cost of ownership mindset
• Identify and engage key stakeholders, understand their 1–3–5 year needs and translate these into category strategies
• Work closely with supplier development and performance management teams to monitor and improve supplier delivery and quality
• Support site procurement to ensure compliance with regulatory requirements and Sarbanes Oxley (SOX)

Associate Director – Global Sourcing and Procurement

Project Manager

• Collaborate with team members to design and implement ICT infrastructure solutions aligned with project schedules and budgets.
• Ensure designs adhere to standards, guidelines, and best practices; advocate for digital-enabling ICT infrastructure.
• Collaborate on the development of project cost estimates, schedules, and documentation deliverables.
• Participate in the design and oversee the build-out of technology rooms.
• Participate in the design and oversee the installation of physical networking.
• Lead the development of logical and wireless network designs.
• Coordinate requirements and sizing for virtualized computing clusters and virtual machines.
• Lead selection, configuration, and installation of shop-floor hardware solutions.
• Support requirements definition and implementation for a digital visual factory and video surveillance system.
• Facilitate weekly status and technical meetings; maintain dashboards; present at higher-level meetings.
• Document, track, and escalate actions, risks, issues, and challenges.

Senior Specialist, Technical Project Management

Account Manager

• The U.S. Oncology Key Account Manager is the main point of contact for our Company with large Oncology group practices and integrated delivery networks that have a focus on Oncology.
• They play a crucial role in establishing our Company as an industry leader, supporting healthcare partners and providers, improving patient health outcomes, and becoming a trusted resource.
• This is a field-based key account management role and will have responsibility for accounts in the Mid-South geography.
• Builds and maintains trust with colleagues, stakeholders, and customers through effective communication, integration, and collaboration.
• Ability to lead through challenging and ambiguous situations while ensuring that deadlines and objectives are met, by effectively prioritizing tasks based on urgency, impact, and resource availability.
• Ability to influence others and lead without authority during complex situations, fostering collaborative problem-solving and reaching consensus.
• Experience in navigating diverse teams or stakeholders to achieve common goals.
• Understands applicable product portfolio to provide approved disease and product information to key decision makers and stakeholders within account(s).
• Leads Our Company's efforts to maximize appropriate utilization of its portfolio while bringing resources to customers that contribute to better outcomes for patients.
• Utilizes internal data and data analytics to understand account performance and identify opportunities for appropriate engagement.
• Establishes strategic approach to the account in alignment with approved guidance from the marketing teams.
• Aligns brand strategy and tactics with customer needs and business objectives to improve patient health outcomes.

Oncology Key Account Manager – Mid-South

Data Scientist

• The ACE lead will partner closely with Medical Modernization team members, TAs, Regional and Country leads to understand healthcare data analytics needs aligned to V&I priorities
• Translates the needs and opportunities into an annual Data Analytics Strategy and manages a large budget for necessary data purchases as approved by the Med Mod Leadership Team
• Leads a team of data scientists who operationalize the Healthcare Data Analytics Strategy by translating priority V&I plans questions (for all TAs and regional needs) into executable, concrete plans using sound methodologies and real-world data to deliver accurate, pertinent and actionable information to the stakeholders on a timely basis.
• Ensures that presentations to stakeholders are well prepared and delivered effectively so that they inform strategic choices, enhance field engagement, and optimize medical affairs activities
• Seeks regular feedback from cross functional stakeholders verifying that the data analytics team adequately delivers upon their needs
• Organizes regular management reviews of the team’s activities and progress
• Ensures that the team maintains an entrepreneurial spirit while focusing on organizational priorities, quality and compliance, and has a strong understanding of healthcare data and technology.
• Able to identify and use new healthcare data sources, and effectively inform V&I plans and priority country medical plans
• Identifies opportunities in key growth areas
• Sets high expectations for execution excellence across all healthcare data analytics projects from ideation to data delivery (including recommendations for action)
• Coaches team to transform data into dynamic, resonant stories, visuals, and other innovative, insightful presentation methods for internal decision making by V&I
• Manages career development and performance management activities, including recruiting, career planning, employee development, training, compensation planning, and performance evaluation
• Keeps abreast of the latest trends in the field through continuous learning and proactively championing new methods to help solve critical and emerging medical affairs problems and drive medical affairs activities
• Fosters collaboration with stakeholders (within V&I, R&D Center for Observational and Real-World Evidence (CORE), Digital Human Health (DHH), and other internal working groups) to drive efficiencies, make best use of data, ensure consistent cohort definitions and share methodologies and innovations in a compliant manner.

Senior Director, Head of Analytics Center of Excellence, Medical Modernization

Therapist

• Lead the planning and implementation of cluster-level medical activities in ophthalmology across PASEBA, including development and execution of the Cluster Medical Affairs Plan that reflects local standards of care, reimbursement environments and clinical practice.
• Build and maintain strong scientific engagement with the ophthalmology community in PASEBA, including scientific leaders and key decision makers, through credible, unbiased exchange of scientific information, advisory boards and tailored educational activities.
• Identify clinical care gaps and unmet scientific needs, driving local data generation and other relevant studies (from feasibility to protocol input and implementation) and contributing insights to global medical strategy and publication plans.
• Represent the PASEBA Cluster within Regional Medical Affairs and collaborate closely with clinical operations to support study allocation, site and investigator selection, and feasibility assessments for global and regional ophthalmology studies.
• Partner actively with cross-functional cluster, country and regional teams (e.g. market access, HEOR, commercial) to provide scientific input into access, reimbursement, and broader brand strategies and initiatives in ophthalmology.
• Maintain a high level of expertise in ophthalmology and be recognized internally and externally as the scientific lead for the therapy area within the PASEBA Cluster.

Therapy Area Lead – Ophthalmology

• Serve as a primary point of contact for customers and meet with key stakeholders to understand practice structure, business model, and key influencers
• Use appropriate resources to create a compelling and logical rationale for the value of our Oncology products during informed discussions with customers
• Possess knowledge of cancer staging, possible treatment options, and dosing schedules associated with different tumors/diseases
• Analyze and identify trends in a complex buying environment
• Develop and execute short- and long-term account plans in collaboration with the account team

Oncology Sales Specialist

• The Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, OD, DO, or MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs).
• The role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products.
• The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights.
• RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies.
• The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise.
• Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products.
• Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company.
• Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies.
• Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD’s specific therapeutic area.
• Upon request from Global Center for Scientific Affairs (GCSA), initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial.
• Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research.
• Identifies barriers to patient enrollment and retention efforts to achieve study milestones.
• Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.
• Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies.

Regional Medical Scientific Director – Ophthalmology

Clinical Research

• Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other our Company's Research Laboratories Scientists in analyzing clinical trials, and in coordinating other statistical activities for clinical drug/vaccine projects under supervision
• Shadowing senior statisticians, serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting
• Under supervision of senior statisticians, participates in study design; performs sample size calculations and simulations to support protocol development
• Under supervision develops statistical analysis plans and determines appropriate statistical methodology for data analysis
• Participates in database design meetings and reviews relevant study documents including CRF, Data Validation Plan, and Medical Monitoring plan to ensure that the data evaluated are in high quality and satisfy analysis requirements
• Collaborates with the statistical programming staff to provide definitions, documentations, and reviews derived variables needed for planned analysis; ensures that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol
• Reviews study results to ensure all the deliveries in high quality
• Under supervision of senior statisticians, prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators
• Involved in research activities for innovative statistical methods and applications in clinical trial development

Biostatistician, Late Development Statistics

Manager

• Coordinates all aspects of observational or non-interventional research activities, which includes the implementation of primary-data collection, chart review/survey, and database studies; health economic model development and adaptations; and other activities in support of Health Technology Assessment (HTA).
• Supports scientist(s) by providing overall operational support for research conduct in compliance with Good Pharmacoepidemiology Practice (GPP), company policies, and standard operating procedures (SOPs).
• Provides operational support of observation or non-interventional research activities, including execution and closeout of primary-data collection, chart review, and database studies in addition to other activity types.
• Manages several complex activities and study types.
• Liaises with and provides oversight/direction to supplier and communicates with internal cross-functional teams to share project status and mitigations.
• Tracks timelines/deliverables and follows up on action items (vendor and internal teams/scientists).
• Assists with review and finalization of all supplier documents, such as monitoring, project management, safety management, data management, and validation plans.
• Participates in protocol and interim/final report preparation, shepherds documents through the internal review process for approval, and submits to the internal repository.
• Coordinates internal/external meeting management and drafts/reviews agendas and minutes.
• Ensures that studies follow all non-interventional processes for informed consent, compliance, site contract and budget review/approval, protocol document review, study registration (when applicable), adverse-event reconciliation, publication submission, and closeout.
• Coordinates confidentiality and consultant agreements, as well as external engagement meetings.
• Participates in quality control and integrity of study data and reports for publications.
• Manages publication development, including formatting, figure/data content development, co-author review, internal review process, and journal submissions.
• Collaborates and troubleshoots issues by providing potential resolutions when necessary to ensure timely management and execution of activities.
• Participates in internal process-improvement initiatives with Research Management and mentors other research managers as necessary.