Sumitomo Pharma America, Inc.

Director

• Actively manage and optimize the value of the relationship between Sumitomo Pharma and assigned corporate partners
• Work with SMPA leadership in all functional areas, as well as assigned corporate partners to set the direction and scope for the partnership annually
• Oversee the governance of the partnership agreement, including participating in governance committees, working group meetings and facilitating decision making
• Serve as a central point of contact to streamline communication and meetings between functional areas within SMPA and across assigned corporate partners
• Develop and cultivate strong relationships directly and through Sumitomo leadership with key contacts at assigned corporate partners to create cross-company alignment and resolve disputes
• Monitor adherence to agreement obligations and deliverables and take appropriate action to ensure execution
• Liaise with legal, finance and functions to ensure that key contract milestones, financial transactions, and progress reports are handled appropriately and provide information/updates/reports as needed
• Participate in partner contract negotiations as appropriate and provide input into partnership execution terms of the contract

Director – Alliance Management

Account Manager

• Deliver results by strategically educating key LTC stakeholders including closed door pharmacies, consultant pharmacists, and Tier 1 Nursing Home chains
• Collaborate with the sales team on educating LTC Healthcare Providers on SMPA product clinical attributes for the LTC resident
• Ensure customer satisfaction by understanding their needs, promoting products or services, and driving purchases to meet or exceed regional GPO purchasing targets
• Work with LTC Pharmacy Accounts to strategically develop and implement education plans
• Build business relationships with senior executives at key accounts

Regional Account Manager – LTC

Administrative Assistant

• Provide comprehensive administrative support to assigned leader(s) and/or department(s)
• Prepare, edit, and format documents, presentations, spreadsheets, and reports
• Manage Legal Department vendors and contracts using contract life cycle management software
• Triage incoming correspondence
• Prepare, submit, and track expense reports on behalf of supported leader(s)
• Create and submit purchase orders, requisitions, and invoices as required
• Support coordination across teams and departments as business needs require
• Contribute to shared administrative coverage when needed
• Handle confidential and sensitive information with discretion and professionalism
• Track action items, deadlines, and deliverables on behalf of supported leader(s)
• Maintain accurate calendars, contact lists, and meeting materials
• Coordinate complex calendars as assigned
• Schedule meetings across multiple stakeholders, locations, and time zones
• Reserve meeting space and coordinate required technology or materials
• Prepare agendas, circulate materials in advance, and distribute notes or action items as needed
• Coordinate domestic and international travel for supported leader(s), including flights, hotels, ground transportation, and itineraries
• Proactively manage changes, cancellations, and travel disruptions
• Plan and support internal meetings, offsites, trainings, and events, including:
• Venue coordination
• Catering
• Supplies and materials
• On-site or virtual logistics
• Manage event timelines and ensure smooth execution

Legal Administrative Coordinator

Manager

• Serve as a programming point of contact between SMPA and SMP
• Facilitate communication and collaboration between SMP programming and SMPA programming, biostatistics, data management, clinical research, clinical operations, medical writing and CROs
• Lead and manage the contactor programmers and provide programming support to clinical trials for regulatory submissions and publications, and ad hoc or post hoc analyses
• Generate SDTM/ADaM datasets, listings, tables and figures, as well as supporting documentation (i.e. define.xml) for clinical trials
• Function as lead (or co-lead together with SMP) programmer on single or multi-protocol projects and participate in project team meetings

Senior Manager, Programming

• Provide timely and professional ongoing management of project and clinical trial data.
• Work closely with outsourced clinical data management (CDM) activities with various Contract Research Organizations (CROs).
• Ensure study team expectations are clearly communicated to the CRO.
• Provide comprehensive data management expertise to deliver efficient data management products.
• Serve as the Lead Data Manager on studies.
• Understand and comply with core standard operating procedures (SOPs).
• Review and approve various CDM documents.
• Communicate ideas for process improvement.
• Provide project updates to management weekly and monthly.

Senior Manager, Clinical Data Management

Vice President

• Lead strategic development, execution and management of medical affairs functions
• Manage field MSL team, HEOR data generation, payer engagement
• Develop medical affairs strategy, scientific and medical information
• Engage with external KOLs and stakeholders
• Plan and oversee all global medical affairs activities
• Build effective medical education and information strategy
• Drive publication strategy and execution
• Develop strategic architecture and manage relationships with KOLs
• Advance data generation aligned with company priorities
• Lead, hire, engage, coach, and develop medical affairs function

Vice President, Medical and Scientific Affairs

• Own the GxP validation lifecycle for all relevant SAP S/4HANA modules and integrated systems
• Lead the execution of all GxP Protocols (IQ, OQ, PQ) and coordinate cross-functional teams
• Serve as the primary SAP GxP subject matter expert during internal and external regulatory inspections and audits
• Lead the analysis, design, configuration, and implementation of complex SAP S/4HANA solutions across various modules
• Manage all aspects of site readiness for SAP deployment
• Develop comprehensive test plans and manage the entire testing phase
• Collaborate with business stakeholders to translate complex business needs into detailed functional specifications

Manager, Enterprise Apps

Operations

• Lead the analysis, design, configuration, and implementation of SAP S/4HANA solutions across the entire value chain
• Own the end-to-end design, configuration, integration, and validation of SAP S/4HANA solutions
• Actively participate in, and often lead, validation activities
• Manage and prioritize project timelines, budgets, and resources for S/4HANA rollouts and enhancement projects
• Provide critical Tier 2/3 operational support, including troubleshooting and complex issue resolution
• Develop and provide ongoing, role-based training and SOPs for end-users

Manager, Enterprise Applications – Tech Ops, SAP

Analyst

• Serve as a liaison between Market Access Commercial Business and IT
• Responsible for delivery and support of technology solutions
• Partner with business stakeholders to support Model N and Anaplan applications
• Oversee end-to-end management of IT projects
• Develop and maintain comprehensive project documentation
• Collaborate with cross-functional IT teams to ensure seamless delivery of services

Senior Analyst, Market Access Applications

• Oversee the strategic and operational management of the company’s vehicle fleet
• Manage all aspects of the company’s fleet program, including vehicle acquisition, inventory, maintenance, fuel programs, and disposal
• Develop and implement fleet policies and procedures to ensure compliance with safety, regulatory, and environmental standards
• Monitor fleet performance metrics and identify opportunities for cost savings and operational improvements
• Coordinate with HR to support onboarding/offboarding of field-based employees
• Ensure accurate and timely reporting of fleet data, including mileage, fuel usage, and incident tracking
• Lead initiatives to improve sustainability and reduce the company’s carbon footprint
• Serve as the primary point of contact for fleet-related inquiries and issue resolution
• Manage the end-of-year driver-tax reporting process for company drivers, ensuring compliance with IRS guidelines

Senior Manager, Fleet

Risk

• Provide study-level leadership for risk-based quality management across Phase 1–4 oncology clinical trials
• Drive data-driven quality oversight, ensuring clinical trial risks are proactively identified, monitored, and mitigated
• Facilitate understanding of the SMPA RBQM Strategy within Clinical Project Teams by providing targeted training sessions
• Lead and facilitate cross-functional risk assessment meetings
• Maintain comprehensive and traceable documentation of all risk assessment activities
• Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and Quality Risk Management Plans (QRMP)
• Ensure alignment of study risks with Critical to Quality (CtQ) factors, protocol requirements, and data quality objectives
• Partner closely with Data Management and Biostatistics to define, implement, and monitor KRIs and QTLs
• Lead the execution of centralized monitoring strategies, including ongoing data review, signal detection, and trend analysis
• Provide expert guidance on targeted SDV and targeted SDR approaches based on evolving risk profiles
• Develop and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership
• Act as the RBQM subject matter expert within Data Management, providing consultation and guidance to cross-functional stakeholders
• Support inspection readiness by ensuring RBQM rationale, documentation, and decisions are inspection-ready and defensible
• Contribute to the continuous improvement of RBQM processes, tools, and standards across Data Management
• Maintain high proficiency in systems and technology as applicable to RBQM monitoring analytics and data access
• Manage direct line reports, providing guidance, mentorship, and performance feedback

Associate Director, Risk Based Quality Management, Oncology

Outside Sales

• Achieve and exceed sales objectives and grow market share
• Manage the assigned territory
• Establish deep and meaningful business relationships
• Increase market share by closing new business in both new and existing accounts
• Support sales results with clinical expertise and understanding of the evolving healthcare landscape
• Collaborate and provide constructive communication with team members
• Travel is required throughout the territory, including overnight stays and potential weekend work

Territory Sales Manager – Specialty

• Provide portfolio-level oversight of RTSM/IRT deployments
• Act as primary vendor manager for IRT providers
• Plan, execute, and deliver RTSM/IRT projects
• Lead design and development of User Requirement Specification (URS)
• Track operational health and manage the full RTSM/IRT lifecycle
• Partner with Data Management analytics platforms
• Provide guidance on system design alternatives
• Serve as the main contact for regulatory inspection activities

IRT Manager

Compliance

• Lead IT compliance and governance programs in a regulated pharmaceutical environment
• Ensure adherence to global regulations (GxP, FDA, EMA)
• Manage IT risk and oversee Business Continuity and Disaster Recovery
• Partner with QA, Regulatory, and IT teams to maintain secure, compliant, audit-ready systems
• Ensure IT systems support GxP processes and comply with relevant regulations
• Maintain IT compliance documentation and oversee periodic assessments
• Develop IT governance frameworks aligned with industry standards
• Conduct IT risk assessments and implement mitigation strategies
• Own and manage the enterprise BC/DR program for IT systems
• Serve as primary IT contact for audits, inspections, and assessments
• Establish IT policies and standards for data integrity and cybersecurity
• Develop and deliver IT compliance and BC/DR training programs

Associate Director, IT Compliance, Governance

• Develop, implement, and maintain DLP policies and controls to safeguard sensitive information from unauthorized access, misuse, or leakage
• Monitor network, endpoints, and cloud environments for potential data breaches and respond to DLP alerts
• Collaborate with IT and Legal teams to configure, test, and optimize DLP solutions
• Conduct risk assessments and vulnerability analyses related to data protection
• Provide training and awareness programs for employees on DLP best practices
• Manage the identification, preservation, collection, and processing of electronically stored information (ESI) for legal and regulatory matters
• Coordinate with Legal, Compliance, and IT teams to execute discovery plans and ensure defensibility of collected data
• Administer litigation hold processes, including issuing, tracking, and releasing holds in collaboration with Legal and Compliance
• Develop and enforce records retention schedules and policies in accordance with regulatory and business requirements