Hansa Biopharma

Director

• Lead Hansa Biopharma's US trade and distribution operations
• Drive channel strategy, distribution partnerships, patient access, compliance, and launch readiness
• Channel strategy and design
• Distribution network management
• Gross-to-net and channel economics support
• Chargeback administration
• Government and commercial contract operations
• Demand forecasting & inventory monitoring
• Data analytics and channel insights
• Compliance, including DSCSA, and risk management
• Work cross-functionally with Supply Chain, Finance, Legal, Regulatory, Quality, Commercial Operations, and Market Access
• Provide functional leadership, vendor oversight, and cross-functional coordination

Director, US Trade and Distribution

Medical Director

• Lead and manage a team of Medical Science Liaisons (MSLs)
• Optimize external scientific engagement with KOLs, HCPs, and healthcare entities
• Collaborate with cross-functional teams to generate tactical plans
• Develop and implement the MSL Effectiveness Model
• Ensure adherence to compliance standards
• Communicate strategic value of Field Medical across internal stakeholders
• Drive generation of field insights
• Foster team advancement through individual development plans and educational initiatives

US Field Medical Director – Team Lead

• Lead and manage a team of Medical Science Liaisons (MSLs)
• Optimize external scientific engagement with KOLs, HCPs, and other stakeholders
• Collaborate with cross-functional teams to generate tactical plans
• Develop and implement the MSL Effectiveness Model
• Conduct observations of MSL external scientific engagement
• Develop field medical strategy in alignment with US Med Affairs strategy
• Drive generation of field insights and ensure communication to relevant stakeholders
• Oversee the development of field medical resources and training plans

Field Medical Director

• Contribute to the development and maintenance of the pharmacovigilance system for Hansa Biopharma AB, including the quality system for the performance of pharmacovigilance activities
• Have full knowledge about current regulation and guidelines within pharmacovigilance, however focused on FDA legislation
• Have an overview of the product(s)’s safety profile where Hansa Biopharma AB is the marketing authorisation holder (MAH)
• Review and approve SAE and ICSR reports
• Review and give input to safety sections in protocols and reports for trials
• Write and/or review aggregated safety reports such as the US PADER, DSUR, PSUR/PBRER, as needed
• Give input on safety sections/documents and analysis, e.g. for MAA/BLA, as needed
• Write and/or review the RMP(s) (EU) and REMS(s) (US), as needed
• Contribute to and participate in the monthly meetings with the pharmacovigilance vendor
• Contribute to and participate in the QPPV Oversight Meetings
• Participate in Safety Committee Meetings
• Participate in pharmacovigilance audits and inspections
• Contribute to the writing/update of relevant SOPs for pharmacovigilance
• Support in the pharmacovigilance training for the staff in the US, as needed
• Contribute to the update/maintenance of the Pharmacovigilance System Master File (PSMF)
• Collaborate with and oversee pharmacovigilance vendors and other vendors impacting the pharmacovigilance system
• Provide guidance and pharmacovigilance training to relevant external stakeholders
• Support the Regulatory Affairs department, including providing input on response to authorities and regulatory actions regarding any safety issue
• Work in accordance with Hansa Biopharma’s SOPs and give regulatory/pharmacovigilance comments on other applicable SOPs, as needed
• Some domestic / international travel expected

Senior Manager/Associate Director, Pharmacovigilance

• Analyze the US healthcare policy and external environment to identify opportunities and risks impacting Hansa’s commercial and clinical‑stage programs.
• Develop and execute a US policy and environment‑shaping plan to support commercialization planning and product launches in the US.
• Collaborate closely with cross‑functional teams (Global Corporate Affairs, Market Access, Commercial, Medical Affairs, R&D).
• Build and maintain strategic relationships with policy makers, public health decisionmakers, and patient advocacy groups.
• Clearly and impactfully communicate Hansa’s policy positions to external stakeholders.
• Oversee and track corporate giving and PAG support initiatives.

Director, US Trade and Distribution

US Field Medical Director – Team Lead

Field Medical Director

Senior Manager/Associate Director, Pharmacovigilance

Associate Director – US Policy and Patient Advocacy