Sobi - Swedish Orphan Biovitrum AB (publ)

Director

• As members of the Health Systems Director team, individuals in this position are responsible for the sales and access strategies that underpin SOBI Rare Disease products in and for achievement of assigned objectives for both the region and assigned institutions/hospitals/health systems
• The Health Systems Director (HSD) will be accountable for working cross-functionally to ensure access to therapy for patients in hospitals and other care settings, as per the product label
• This includes appropriate management and coordination of supporting SOBI teams to engage with health system stakeholders including C-Suite leaders, P&T committees, Pharmacy Directors, and external experts
• Health Systems Directors are accountable for coordinating their own account-based activities alongside those in Market Access, Patient Services, and medical teams who have responsibilities in the same accounts
• Strong clinical acumen will be paramount in this role
• The HSD is responsible for effectively sharing on-label scientific information that translates into real world practice
• The HSD will build strong relationships with key decision makers throughout their accounts and will provide customers with product and disease information that helps them develop and implement protocols for optimal patient care
• The Health Systems Director will be responsible for nurturing and channeling advocacy to support patient protocols consistent with the full parameters of the label
• The HSD will develop and execute account plans based on the national and regional strategies

Health Systems Director

Business Development Rep

• Lead U.S. commercial assessments for acquisition, licensing, partnership and strategic business development opportunities
• Evaluate strategic fit, unmet need, treatment paradigms, competitive intensity, market attractiveness and long-term commercial potential
• Support internal portfolio strategy initiatives including new indications, lifecycle management opportunities, reformulations and line extensions
• Develop recommendations regarding commercial viability, launch feasibility, investment requirements, organizational implications and key risks
• Assess alignment with corporate strategy and long-term growth objectives
• Lead commercial due diligence activities
• Assess epidemiology, diagnosed populations, treated populations, addressable patient populations, treatment algorithms and site-of-care dynamics
• Develop market sizing methodologies and opportunity assessments
• Conduct primary and secondary research to validate assumptions
• Partner with Business Analytics to validate epidemiology, patient opportunity and forecast inputs
• Evaluate competitive landscapes, pipeline threats and future market evolution
• Participate actively in diligence meetings with target companies and consultants
• Develop pricing recommendations and commercial pricing frameworks
• Evaluate pricing potential relative to clinical differentiation and payer expectations
• Develop gross-to-net assumptions and reimbursement frameworks
• Assess Medicare, Medicaid, Commercial, Specialty Pharmacy and Buy-and-Bill reimbursement implications
• Evaluate payer management expectations, utilization management risks and access barriers
• Assess coding, payment, contracting, distribution and channel considerations
• Support assessment of evolving healthcare policy initiatives and their potential impact on commercial opportunity, pricing strategy, reimbursement, and long-term asset value
• Partner with Market Access leadership to evaluate policy developments related to GLOBE, GUARD, GENEROUS, MFN initiatives, and other pricing and reimbursement reform efforts
• Develop analyses evaluating policy-related risks and opportunities associated with acquisition, licensing, and portfolio opportunities
• Support scenario planning exercises assessing policy impacts on pricing, reimbursement, access, contracting, and commercialization assumptions
• Collaborate with Market Access subject matter experts to incorporate policy considerations into asset evaluations and strategic recommendations
• Develop commercialization strategies and launch planning recommendations
• Assess launch feasibility and organizational capabilities required for commercialization
• Develop recommendations regarding sales force size, deployment models, targeting strategies and customer engagement approaches
• Assess patient support services, HUB operations, field reimbursement, nurse educator requirements, specialty pharmacy support and distribution strategies
• Partner with Finance to develop commercialization investment assumptions and operating expense estimates
• Develop build-versus-buy recommendations and organizational capability assessments
• Support Market Access integration planning activities for acquired, licensed, or partnered assets
• Serve as the primary Market Access liaison to the central integration management team for assigned opportunities
• Develop recommendations regarding Market Access integration requirements, including pricing, reimbursement, patient support, contracting, distribution, field reimbursement, and access strategy considerations
• Partner with cross-functional stakeholders to identify integration risks, capability gaps, resource requirements, and implementation timelines
• Support development of integration workplans and readiness assessments
• Coordinate Market Access deliverables associated with integration activities and commercialization planning
• Monitor progress against integration milestones and support issue identification and resolution
• Develop recommendations regarding future-state operating models and organizational requirements for integrated assets
• Develop commercial assumptions related to pricing, reimbursement, access, uptake, competitive response and lifecycle opportunities
• Support scenario planning and sensitivity analyses
• Partner with Finance and Business Development to refine revenue assumptions and investment scenarios
• Assess clinical differentiation, value proposition strength and competitive positioning
• Evaluate evidence requirements necessary to support reimbursement and adoption
• Identify evidence gaps impacting commercial success
• Partner across Business Development, Commercial, Market Access, Medical Affairs, Business Analytics, Finance, Regulatory and Legal
• Support leadership decision-making through objective, data-driven recommendations

Director, Commercial Strategy and Business Development

Account Executive

• Act as a single point of contact in the field for the US Market Access Regional Payer team for the defined geographical region
• Support the entire SOBI portfolio and work to ensure optimal market access
• Engage payers and influencers to enhance payer policy
• Insure appropriate product formulary placement and work to increase overall patient access to our products
• Engage with various stakeholders, influencers, and customer types including Payers, PBM’s, Advocacy groups, Hospital Academia, IDNs, ACOs, C-Suite, High-Cost Drug Committees and Community Oncology Accounts
• Develop strategies to meet and exceed goals by facilitating optimal and profitable access in various channels of business
• Advance current policies, protocols, and pathways to assist patients with access to our products
• Facilitate the exchange of clinical / economic evidence to formulary decision makers and C-Level decision makers
• Co-lead contracting and pull-through initiatives partnering with commercial leadership to build and execute pull-through plans
• Lead without authority in a matrix environment
• Communicate critical competitive intelligence and insights within the market access marketplace

Regional Account Director

Supply Chain

• Develop CEERJ Supply Chain Strategy objectives key results
• Analyze, propose and get approval for continues Supply Chain improvement initiatives
• Apply latest digital and data strategic tools to add value for patients, customer and SOBI company
• Apply situational leadership behaviors across the organization
• Unlock potential of diverse teams by effective collaboration and content-based discussion to deliver superior results
• Stay focused on mission critical items among daily routine
• Communicate with impact across the organization of complex situations, decisions and actions taken

Head Supply Chain – CEERJ

Head Supply Chain CEERJ

Product Manager

• Perform and lead safety surveillance and benefit–risk activities for assigned products
• Set the strategy for safety signal detection methodology
• Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented
• Lead and perform assessments for preparation, review and approval of key safety deliverables
• Translate safety data insights into actionable recommendations
• Lead clinical safety science interactions with partner companies
• Act as the Safety Science representative in the Medical Development Team (MDT)
• Provide clinical safety input into study design, conduct, analysis and interpretation
• Chair product-level Benefit Risk Teams (BRTs)
• Represent the BRT at Benefit Risk Council (BRC)
• Mentor colleagues and support capability development within the product safety team

Global Product Safety Science Lead

• Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).
• Set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals for assigned products.
• Drive, perform and document benefit‑risk evaluations and ensure appropriate risk‑management strategies are implemented.
• Lead and perform assessments for the preparation, review and approval of key safety deliverables (e.g. PSURs, DSURs, RMPs, regulatory responses).
• Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions.
• Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of safety into product development and lifecycle decisions.
• Provide clinical safety input into study design, conduct, analysis and interpretation, including study‑level Safety Lead responsibilities where applicable.
• Chair product‑level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs.

Account Manager

• Maximize sales of our brands in the defined territory
• Develop and implement account plans based on customer insights
• Manage relationships with key customers and stakeholders
• Execute and revise account/brand plans as needed
• Analyze sales performances and customer engagement activities

Key Account Manager

Full-stack Engineer

• Subject matter expert (SME) for Small Molecules Drug Substance Manufacturing.
• Process owner of Small Molecules process validation for Sobi products.
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
• Participate in internal activities related to (external) manufacturing, such as process changes, major/critical deviations, risk assessments, and CAPAs.
• Issue, review, and approve applicable internal and external SOP’s and manufacturing instructions.
• Review and supervise the setup, execution, and documentation of technical studies, qualifications, and validations.
• Write and review applicable sections of the APR/PQR.
• Write and review applicable sections in registration files, variations, and market expansion.
• Support in sourcing evaluation of new Small Molecules contract manufacturers and participation in developing supply and quality agreements.
• Lead the technical part of a product transfer, scale-up activities, validations, and oversee manufacturing of Small Molecules processes at external manufacturers for Sobi projects in the clinical and commercial phase.
• Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies, and how they may be applicable to process innovation, cost, or yield improvement.

MSAT Technical Lead – Drug Substance

• Subject matter expert (SME) for Small Molecules Drug Substance Manufacturing.
• Process owner of Small Molecules process validation for Sobi products.
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
• Participate in internal activities related to (external) manufacturing, such as process changes, major/critical deviations, risk assessments, and CAPAs.
• Issue, review, and approve applicable internal and external SOP’s and manufacturing instructions.
• Review and supervise the setup, execution, and documentation of technical studies, qualifications, and validations.
• Write and review applicable sections of the APR/PQR.
• Write and review applicable sections in registration files, variations, and market expansion.
• Support in sourcing evaluation of new Small Molecules contract manufacturers and participation in developing supply and quality agreements.
• Lead the technical part of a product transfer, scale-up activities, validations, and oversee manufacturing of Small Molecules processes at external manufacturers for Sobi projects in the clinical and commercial phase.
• Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies, and how they may be applicable to process innovation, cost, or yield improvement

Communications

• Lead the global brand communications strategy, including launch readiness, data milestone planning, and lifecycle communications
• Maintain the brand narrative consistently across all channels and stakeholders
• Partner with Disease State Awareness lead on product media strategy, including channel selection, prioritization, and media investment (paid, earned, and owned)
• Build and manage relationships with key international and specialty media
• Guide affiliates in local media engagement, ensuring consistency, compliance, and quality
• Lead the brand congress communications roadmap (pre-, during-, and post-congress)
• Oversee development of global congress toolkits and ensure strong local amplification across markets
• Coordinate Support cross-functional alignment (Medical, IR, Compliance) for data communication and own media engagement
• Develop and deploy global communication toolkits, digital assets, and campaign playbooks for affiliate use
• Oversee development of high-quality communication materials, including narratives, Q&As, digital content, and presentations
• Partner closely with country teams to strengthen capabilities and drive high-quality execution
• Lead agency management, ensuring strategic alignment, quality delivery, and efficient execution
• Partner with Medical and Brand teams to ensure scientific integrity and strong educational impact
• Collaborate with Community Engagement to amplify the patient voice and strengthen external partnerships
• Align with Corporate/IR Communications to ensure consistency and clarity of external messaging
• Lead global insight gathering (media landscape, social listening, advisory boards) to inform strategy
• Define and track KPIs to measure communication effectiveness and optimize impact
• Continuously refine communication approaches based on data, insights, and evolving market dynamics
• Drive continuous improvement of communications capabilities across international markets
• Introduce and scale best practices data-driven communications and promote the use of new tools, including AI, to enhance efficiency, personalization, and impact
• Manage the budget for communication programs; forecast, track ROI, and reallocate for impact while operating to SOPs, industry codes, and corporate values

Global Brand Communications Director

• Lead the global brand communications strategy, including launch readiness, data milestone planning, and lifecycle communications.
• Maintain the brand narrative consistently across all channels and stakeholders.
• Partner with Disease State Awareness lead on product media strategy, including channel selection, prioritization, and media investment (paid, earned, and owned).
• Build and manage relationships with key international and specialty media.
• Guide affiliates in local media engagement, ensuring consistency, compliance, and quality.
• Lead the brand congress communications roadmap (pre-, during-, and post-congress).
• Oversee development of global congress toolkits and ensure strong local amplification across markets.
• Coordinate support cross-functional alignment (Medical, IR, Compliance) for data communication and own media engagement.
• Develop and deploy global communication toolkits, digital assets, and campaign playbooks for affiliate use.
• Oversee development of high-quality communication materials, including narratives, Q&As, digital content, and presentations.
• Partner closely with country teams to strengthen capabilities and drive high-quality execution.
• Lead agency management, ensuring strategic alignment, quality delivery, and efficient execution.
• Partner with Medical and Brand teams to ensure scientific integrity and strong educational impact.
• Collaborate with Community Engagement to amplify the patient voice and strengthen external partnerships.
• Align with Corporate/IR Communications to ensure consistency and clarity of external messaging.
• Lead global insight gathering (media landscape, social listening, advisory boards) to inform strategy.
• Define and track KPIs to measure communication effectiveness and optimize impact.
• Continuously refine communication approaches based on data, insights, and evolving market dynamics.
• Drive continuous improvement of communications capabilities across international markets.
• Introduce and scale best practices data-driven communications and promote the use of new tools, including AI, to enhance efficiency, personalization, and impact.
• Manage the budget for communication programs; forecast, track ROI, and reallocate for impact while operating to SOPs, industry codes, and corporate values.