Asahi Kasei

Manager

• Serve as the MS&T Product Lead for the commercial small molecule product throughout its lifecycle
• Develop and execute manufacturing science strategies supporting a high-volume commercial program
• Provide advanced technical leadership supporting commercial manufacturing campaigns
• Drive continuous improvement initiatives focused on process capability, manufacturing reliability, product quality, and operational efficiency
• Lead execution of process validation and PPQ studies for new scales and suites
• Own CPV strategy, execution, and data trending across the commercial program
• Lead manufacturing investigations, deviations, CAPAs, and change controls
• Collaborate with Quality Assurance and Quality Control to ensure compliance and performance
• Manage supplier technical performance through governance meetings and business reviews
• Author technical content of regulatory submissions supporting global filings

Senior Manager, Manufacturing Sciences – Technology

Medical Director

• Leads the development of the annual medical strategic plan together with Medical Affair leadership team.
• Contributes to the medical evidence generation strategy, including real-world evidence (RWE), investigator-sponsored studies (IIS), and collaborative research efforts.
• Provides medical input into clinical development plans, target product profiles, and lifecycle management strategies across pipeline and marketed products.
• Builds and maintains trusted partnerships with key opinion leaders, academic experts, and healthcare providers.
• Serves as an internal medical advisor and point of contact for key cross-functional teams and committees.
• Contributes to publication strategy development in partnership with cross-functional colleagues.
• Supports pipeline planning and early-phase development efforts, providing medical input.

Medical Director, Infectious Diseases

Medical Science Liaison

• Identifies and conducts outreach to key HCPs within the assigned territory to build and strengthen relationships
• Conducts scientific exchange through one-to-one HCP meetings and small group discussions on disease state and treatment options
• Leads and facilitates advisory boards and other activities that inform strategic directions
• Collaborates with commercial counterparts in a professional and compliant manner
• Communicates appropriately with internal stakeholders on relevant clinical information and practice trends
• Responds appropriately to unsolicited questions from HCPs following the Company’s SOPs
• Responds timely to HCP requests for medical information with complete documentation of information exchanged
• Communicates timely HCP interest in lifecycle studies to internal stakeholders, as well as identifies potential study sites
• Identifies opportunities for data generation activities through investigator-initiated research
• Participates in, and successfully completes, all assigned education / training on the Company’s SOPs
• Maintains clinical and technical expertise in relevant therapeutic areas by reviewing scientific journals and participating in educational / training programs

• Provide management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence
• Serve as a safety liaison with the Company’s cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance
• Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to: Oversight of US AE call center; Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs; Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter; Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners; Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP); Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF); Provision of vendor project specific training; Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates; Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; and Maintaining knowledge of safety systems (Argus experience preferred);
• Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines
• Support internal / external audits and regulatory inspections
• Assist in management of pharmacovigilance vendor contracts and forecasting activities
• Assist in management of license partner safety data exchange agreements (SDEA)
• Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company’s policies and procedures
• Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports
• Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization
• Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance
• Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan

Manager, Global Drug Safety – Pharmacovigilance

Business Operations

• Develop and execute the enterprise Business Systems strategy aligned with objectives and digital transformation enablement initiatives.
• Ensure your team is the primary systems business partner to functional business leaders across Finance, Supply Chain, Commercial Operations, Medical, Quality, Clinical, Regulatory Affairs and Corporate Functions.
• Lead cloud-based use of enterprise systems, automation initiatives, analytics capabilities, and digital business processes.
• Identify opportunities to improve operational efficiency, business agility, user experience, and data-driven decision making.
• Build and maintain a multi-year system and transformation enablement roadmap aligned with business priorities.
• Drive organizational change management through your team to ensure successful adoption of new systems and processes.
• Lead, mentor, and develop a high-performing global team supporting business systems.
• Successfully manage virtual and geographically distributed teams across Europe and North America.
• Foster a coaching-based leadership culture focused on accountability, continuous improvement, employee development, and collaboration.
• Promote a culture of business enablement and value creation by efficient use of systems supported by customer service, IT operational excellence, and business partnership.
• Build strong relationships with functional business leadership and business stakeholders across the enterprise.
• Act as a trusted advisor by translating business strategy into system capabilities and solutions.
• Continuously improve our Business IT Operating model to align business priorities, technology investments, and resource allocation.
• Facilitate effective communication between technical and non-technical stakeholders.
• Drive business case development and value realization for system investments.
• Provide leadership and governance for enterprise business systems including but not limited to: ERP platforms Financial systems CRM platforms Commercial applications Data and analytics solutions Integration platforms.
• Manage business system project portfolio covering implementation, optimization, and lifecycle management of enterprise systems.
• Drive standardization and continuous improvement across global business processes.
• Support business growth through scalable and sustainable system solutions.
• Establish and drive data governance, master data management, and information management practices.
• Ensure data quality, integrity, security, and compliance across business systems.
• Promote data-driven decision-making through dashboards, KPIs, and executive reporting.
• Enable advanced analytics and AI-ready data capabilities through strong governance frameworks.
• Define and manage system and service performance metrics.
• Establish KPI frameworks and dashboard reporting that drive accountability and business results.
• Lead system benefits value realization follow-up close partnership with team and business stakeholders.
• Regularly communicate portfolio status, risks, dependencies, and outcomes to IT PMO & CIO.
• Ensure compliance with regulatory, privacy, cybersecurity, and quality requirements.
• Support validation and lifecycle management of regulated systems.
• Partners with IT Compliance leader to maintain appropriate IT governance controls.
• Establish and maintain operating procedures within the team.
• Manage vendor relationships and third-party service providers in accordance with company standards.

Executive Director, IT Business Systems

• Organize bi-weekly meetings with Patient Advocacy Organizations; not limited to managing agendas, maintaining notes, and distributing follow-ups
• May be required to attend workshops and national meetings of organizations; note, weekend travel may be required
• Work with Senior Director to evaluate sponsorship opportunities vs. strategy to determine support level and allocate budget within advocacy designated spend
• Provide brand requests to external organizations as well as develop specific MLR-approved content for sponsorships
• Assist with market research projects to effectively analyze customer insights, brand performance, market trends and competitive response
• Execute select programs; some may be in collaboration with other Marketing team members
• Lead contact of Patient Ambassador program; not limited to recruitment of new patients, working with agency partners to maintain database and support execution of any Ambassador video shoots to gather content
• Cross-functional engagement strategy and collaboration with Operations, Medical, Legal, Sales, Compliance, and Market Access
• Coordinate with Medical team on Clinical Trial initiatives and recruitment
• Coordinate with Corporate Communications on internal patient-focused value initiatives
• Effectively manage agency partners, the budget, and appropriate allocation of resources
• Work closely with the Senior Director, US Patient Marketing and key matrix team members to contribute to the overall strategy for TARPEYO and TARPEYO Touchpoints
• Maintain and update adherence-focused initiatives through TARPEYO Touchpoints program
• Partner with Market Access Team and specialty pharmacy partners to enhance HUB programs

Manager, Patient Relationships – Adherence

• Provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements
• Works directly with the Company’s partners to ensure testing is compliant with Quality, Regulatory, and Company requirements
• Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs
• Oversees CMC method (large molecule) development, validation, qualification, and transfers at CRO/CDO/CMOs
• Oversees CMC stability programs at CRO/CDO/CMOs
• Provides expert review, assessment, and trending of CMC analytical data from CRO/CDO/CMOs
• Oversees characterization, qualification, and life-cycle management of reference materials
• Serves as technical lead for CMC analytical testing
• Manages CMC methods and specifications for release and stability
• Efficiently communicates project tasks, deliverables, and timelines to external partners
• Authors appropriate documentation in a timely manner to support regulatory filings, including but not limited to IND, IMPD, NDA/BLA, and pre- and post-approval changes
• Authors, reviews, and/or approves all technical related protocols, SOPs, change controls, and reports, as needed
• Supports partners in all activities related to CMC analytical development
• Assists in the department’s successful and efficient execution of departmental/area goals
• Supports the Quality Assurance department in auditing activities of CRO/CDO/CMOs
• Prepares for regulatory agency inspections

Senior Manager, CMC Analytical Development

• Prepare clinical development plans according to the nature of the clinical project and its objectives
• Oversee protocol development from concept to final protocol
• Serve as sponsor contact for key study sites on protocol related topics
• Write, edit, and review medical and scientific elements of both internal and external facing documents inclusive of clinical research
• Manage Key Opinion Leader and Medical Advisory Board interactions
• Assist Clinical Operations with supervision of activities of contract research organizations by reviewing key study plans and performance/quality

Senior Director, Clinical Development

Account Manager

• Manage all business with assigned tier 1 and tier 2 automotive customers.
• Grow profitable sales according to plan at current customers and prospects.
• Identify all customer requirements and needs and expand sales according to plan.
• Understanding customer strategy, products, processing and other operational value drivers to ensure APNA products are positioned appropriately.
• Develop contacts with customers at all functions and levels including purchasing, production, logistics, marketing, sales, research and development and technical service.
• Develop full understanding of Asahi Kasei Plastics products.
• Ability to participate and conduct technical and marketing presentations at customers meetings required.
• Balance short-term and long-term objectives effectively within segment to deliver year-over-year growth.
• Responsible for profit and loss of managed accounts.
• Develop and apply a strong understanding of the company's pricing strategy and commercial approach, execute pricing strategies that align with market positioning, customer value and profitability objectives.
• Leveraging pricing as a strategic driver to grow revenue and improve margins within assigned accounts.

Senior Strategic Account Manager

Marketing

• The Director of Market Access Marketing will be responsible for supporting the broad Market Access team in the creation of all strategy and resources for Market Access and field-based access related resources and messaging.
• This individual will also be responsible for helping shape and executing the company’s market access strategy to ensure optimal product positioning, reimbursement, and patient access across key markets.
• This role requires a deep understanding of payer dynamics, and provider marketing needs including value communication, and evidence generation, as well as the ability to align cross-functional teams around access objectives.
• The Director will manage the department and partner closely with internal functions and external partners as well as the US leadership team to build resources that demonstrate and communicate product value and address patient access barriers to payers, providers, and health systems, ultimately contributing to commercial success.

Director, Market Access Marketing

Compliance

• Overseeing day-to-day compliance activities while driving proactive, risk-based approaches that support business objectives and enable compliant growth.
• Serving as a trusted advisor to assigned business functions, providing strategic and operational leadership across core compliance activities, including guidance and advisory support, training, monitoring, policy governance, investigations support, and issue resolution.
• Influencing business decision-making, identifying emerging risks, and implementing practical solutions that support organizational objectives while maintaining compliance with applicable laws, regulations, industry standards, and company policies.
• Partnering closely with stakeholders across the organization and helping ensure Compliance is embedded as a strategic enabler throughout all stages of product development, commercialization, and business growth.

Associate Director, Compliance Business Partner – Pharmaceuticals

Director

• Responsible for leading the Field Access Manager (FAM) Team in its support of patient access in infectious disease
• Educates accounts on effective and efficient processes that maximize patients’ access to prescribed product(s)
• Supports HCPs throughout the enrollment and access process
• Leads the FAM team in building account confidence in patient access through education around the access journey, payer coverage landscape, transitions of care and all appropriate access resources
• Coordinates and collaborates internally with Market Access, Sales, Marketing, and all Patient Support Services
• Builds a FAM Team for the Company’s new brand launch in the infectious disease space
• Partners with Patient Access and Market Access Marketing to ensure appropriate training resources and HCP facing materials are available
• Coaches, motivates, and leads FAMs to achieve goals and objectives with a focus on accountability, results, and collaboration
• Ensures the Field Access team maintains compliant behaviors as related to HIPAA/patient privacy and accurate documentation in the CRM system
• Develops strategies and processes, in partnership with cross-functional teams, to overcome access barriers in a compliant manner
• Evaluates needs and leads development of patient access resources to better educate accounts
• Provides relevant and timely performance updates to senior leadership

Director, Field Access – Infectious Disease

• Lead and manage IT support services (Internal and External)
• Monitor service performance, analyze trends, and implement improvements to enhance service quality and customer satisfaction.
• Facilitate resolution of complex or escalated technical issues, engaging the appropriate internal and external resources.
• Ensure consistent follow-up with internal and external customers to maintain high levels of satisfaction.
• Lead, mentor, and develop IT Service Delivery personnel, including support staff, engineers, and managers.
• Foster a culture of accountability, continuous learning, and high performance across IT teams.
• Recommend and justify investments in technology through cost-benefit analysis and business case development.
• Lead the implementation of a new ITSM platform (HALO)
• Ensure compliance with internal policies and external regulatory requirements through periodic audits and assessments.
• Technical change approver
• Oversee the design, implementation, and maintenance of IT infrastructure, including hardware, software, and network systems.
• Manage relationships with technology vendors, contractors, and service providers to ensure high-quality service delivery.
• Create performance metrics to proactively identify risks and opportunities for improvement.

Director, IT Service Delivery

Sales

• Provides strategic leadership and direction to national team to achieve or exceed area sales targets and business objectives.
• Maintains deep expertise in therapeutic areas, product portfolio, and evolving healthcare landscape to guide decision-making.
• Develops and executes a comprehensive national business plan aligned with the Company’s brand strategies and corporate goals.
• Analyzes market dynamics, competitive landscape, and customer insights to identify opportunities and mitigate risks.
• Drives consistent execution of sales strategies across regions while ensuring adaptability to local market conditions.
• Ensures all business activities comply with applicable laws, regulations, and Company policies.
• Builds, leads, and develops a high-performing leadership team through coaching, mentoring, and talent development initiatives.
• Establishes a culture of accountability, collaboration, and continuous improvement across the assigned area.
• Ensures alignment and strong cross-functional collaboration with the broader sales organization, Marketing, Market Access, Patient Services/Support, Business Intelligence and other key partners.
• Monitors and manages regional-level financial performance, including budget oversight and contribution to P&L objectives.
• Leads national and regional business reviews, planning sessions, and performance management processes.
• Provides actionable insights and feedback to senior sales leadership to inform national strategy and business planning.
• Champions Company values, ethical standards, and a patient-first mindset in all activities.
• Responsible for assigned annual budgets, including scheduled forecast and expenses updates.