Sobi - Swedish Orphan Biovitrum AB (publ)

Product Lead

• Perform and lead signal detection, evaluation, validation and escalation activities for assigned products
• Set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals
• Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented
• Lead and perform assessments for key safety deliverables, including PSURs, DSURs, RMPs and regulatory responses
• Translate safety data insights into actionable recommendations for product-level benefit-risk discussions and regulatory interactions
• Lead clinical safety science interactions with partner companies and ensure sharing of safety information per the SDEA and collaborative functioning of the JSMT
• Provide safety scientific input to the ISS Evaluation Committee as required
• Work cross-functionally on product quality escalations and, when required, lead preparation of medical impact Health Hazard Assessment statements
• Act as Safety Science representative in the Medical Development Team and integrate 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
• Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile, and maintenance of the RSI, including IB and CDS governance
• Chair product-level Benefit Risk Teams and represent the BRT at Benefit Risk Council
• Serve as primary decision-maker for product-level safety issues, including signal validation and escalation
• Lead interactions with external partners and service providers related to product safety deliverables
• Support product-level regulatory interactions, inspections and audits
• Mentor colleagues and support capability development within the product safety team
• Use and develop safety systems, data visualization tools and AI-enabled analyses to support signal detection, safety assessments and decision-making
• Identify opportunities for process, data and system improvements within Safety Science
• Work independently with accountability for assigned products, escalating complex or cross-product issues as appropriate

Global Product Safety Science Lead

• Perform and lead signal detection, evaluation, validation and escalation for assigned products
• Set strategies for safety signal detection methodology, signal tracking and oversight
• Drive and document benefit-risk evaluations and implement risk-management strategies
• Lead assessments and preparation, review and approval of PSURs, DSURs, RMPs and regulatory responses
• Translate safety data insights into recommendations for product-level benefit-risk discussions and regulatory interactions
• Lead clinical safety science interactions with partner companies and ensure safety-information sharing
• Provide safety scientific input to the ISS Evaluation Committee
• Assess product-quality escalation impacts on patients and lead Health Hazard Assessment statements when required
• Represent Safety Science in the Medical Development Team and integrate safety into development and lifecycle decisions
• Provide clinical safety input into study design, conduct, analysis and interpretation
• Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile, RSI, IB and CDS governance
• Chair product-level Benefit Risk Teams and represent them at the Benefit Risk Council
• Serve as primary decision-maker for product-level safety issues
• Lead interactions with external partners and service providers
• Support product-level regulatory interactions, inspections and audits
• Mentor colleagues and support capability development
• Use and develop safety systems, data visualization tools and AI-enabled analyses for signal detection, safety assessments and decision-making
• Identify process, data and system improvement opportunities within Safety Science
• Work independently with accountability for assigned products and escalate complex issues appropriately

Medical Science Liaison

• Engage healthcare professionals to exchange clinical, scientific, and research knowledge
• Build scientific relationships and collaborations with the medical/scientific community
• Interact with key thought leaders, healthcare professionals, and external parties in an accurate, fair, and balanced manner
• Serve as the primary field contact for Sobi Medical Affairs
• Report field intelligence, competitive information, compound perspectives, disease-state information, and treatment-landscape insights
• Support clinical development and operations through site recommendations, site initiation visits, communication facilitation, and accrual support
• Participate in or lead local, regional, and national advisory board meetings
• Provide internal and external training on preclinical science, clinical data, and outcomes
• Represent Sobi at medical conferences and provide session summaries
• Provide cross-functional scientific support
• Maintain advanced knowledge of relevant studies, compounds, and diseases in immunology
• Manage the assigned territory and contribute to the MSL organization
• Travel throughout Nevada, Arizona, Utah, and Southern California

Medical Science Liaison, Senior

Account Manager

• Act as the primary customer contact for sales demand creation
• Execute marketing strategy and promote Sobi products as directed by the Regional Sales Director
• Provide current and comprehensive clinical knowledge of Sobi products
• Communicate on-label clinical benefits of products
• Achieve territory sales by executing Plan of Action marketing strategies
• Deliver branded sales messages to customers
• Represent Sobi at local meetings
• Achieve or exceed sales targets within the assigned geographic territory
• Represent Sobi products and services to a defined customer base
• Generate and grow sales and promote appropriate use of products to healthcare professionals
• Develop and implement a territory business plan
• Analyze territory sales data weekly to prioritize physician targeting and ensure accurate reporting
• Prepare territory budget plans for customer contacts, local symposia, and external expenditures
• Identify and resolve issues and opportunities and communicate with sales and marketing management
• Report adverse events to Sobi’s Drug Safety department
• Perform administrative functions including reporting call activity and customer information, and submitting expenses
• Travel throughout the assigned territory, including overnight travel

Hematology Clinical Account Manager – Senior

General

• Participate in the development and lead execution of medical pre-launch and launch activities for an Immunology asset
• Adhere to the highest scientific and ethical standards
• Execute global medical strategy and tactical plans for pre-launch and launch
• Manage engagement of global key opinion leaders
• Provide input to clinical development activities
• Develop internal and external medical/scientific communication and education deliverables
• Develop external and internal training and training materials
• Provide scientific input to external and internal scientific publications
• Support cross-functional projects
• Provide scientific input to materials developed by cross-functional teams
• Build and develop relationships with key external stakeholders
• Contribute to cross-functional headquarters teams, local affiliate offices, and collaborative partners

Medical Program Lead

Medical Director

• Lead the medical strategy for the Cutaneous T-Cell Lymphoma disease area within Hematology Medical Affairs
• Drive brand medical strategy and external engagement with opinion leaders, community physicians, medical societies, and top accounts
• Lead launch preparatory efforts for lacutamab, a humanized monoclonal antibody immunotherapy targeting KIR3DL2
• Serve as the lead medical voice for lymphoma and lacutamab
• Conceptualize and implement the US medical strategy for the disease area
• Report to the Vice President, Head of Hematology Medical Affairs
• Partner with Field Medical to engage healthcare professionals, medical organizations, payers, and patient advocacy groups
• Act as the medical lead on the Brand Team
• Provide strategic leadership for medical strategy, brand-aligned tactics, and external clinician engagement
• Own launch readiness, including disease education, unmet need articulation, and evidence generation planning
• Contribute analytic expertise and insights to Medical Affairs deliverables
• Develop and enhance KOL and key institution engagement plans
• Collaborate on field materials and tactics specific to CTCL and lacutamab
• Lead planning and execution of advisory boards and educational activities, including webinars, medical roundtables, symposia, and congress presence
• Generate and share medical insights with the field team and analyze insights to inform strategy and tactical adjustments
• Contribute to evidence generation projects, real-world evidence studies, and publications
• Build collaborative relationships with Market Access, Medical Information, Clinical Development, Sales, and Marketing
• Support cross-functional initiatives across the organization
• Contribute to a strong team culture within Hematology/Oncology Medical Affairs

Senior Medical Director – Hematology, Lymphoma

• Lead the medical strategy for the Cutaneous T-Cell Lymphoma disease area within Hematology Medical Affairs
• Drive brand medical strategy and external engagement with opinion leaders, community physicians, medical societies, and top accounts
• Lead launch preparatory efforts for lacutamab
• Serve as the lead medical voice for lymphoma and lacutamab
• Conceptualize and implement the US medical strategy for the disease area
• Report to the Vice President, Head of Hematology Medical Affairs
• Partner with Field Medical to engage healthcare professionals, medical organizations, payers, and patient advocacy groups
• Act as the medical lead on the Brand Team
• Own launch readiness, including disease education, unmet-need articulation, and evidence-generation planning
• Contribute analytic expertise and insights to Medical Affairs deliverables
• Develop KOL and key-institution engagement plans
• Collaborate on field materials and tactics specific to CTCL and lacutamab
• Plan and execute advisory boards and educational activities, including webinars, medical roundtables, symposia, and congress presence
• Generate and share medical insights with the field team
• Contribute to real-world evidence studies and publications
• Build relationships with Market Access, Medical Information, Clinical Development, Sales, and Marketing
• Support cross-functional initiatives across the organization
• Contribute to team culture within Hematology/Oncology Medical Affairs

Senior Medical Director, Hematology – Lymphoma

• Lead the medical strategy for the Cutaneous T-Cell Lymphoma disease area within Hematology Medical Affairs
• Drive brand medical strategy and external engagement with opinion leaders, community physicians, medical societies, and top accounts
• Lead launch preparatory efforts for lacutamab
• Serve as the lead medical voice for lymphoma and lacutamab
• Conceptualize and implement the US medical strategy for the disease area
• Report to the Vice President, Head of Hematology Medical Affairs
• Partner with Field Medical to engage healthcare professionals, medical organizations, payers, and patient advocacy groups
• Act as the medical lead on the Brand Team
• Provide strategic leadership for medical strategy, brand-aligned tactics, and external clinician engagement
• Own launch readiness for lacutamab, including disease education, unmet need articulation, and evidence generation planning
• Contribute analytic expertise and insights to Medical Affairs deliverables
• Develop and enhance key opinion leader and key institution engagement plans
• Collaborate on field materials and tactics specific to CTCL and lacutamab
• Lead advisory boards and educational activities, including webinars, medical roundtables, symposia, and congress presence
• Generate and share medical insights with the field team
• Contribute to evidence generation projects, real-world evidence studies, and publications
• Build collaborative relationships with Market Access, Medical Information, Clinical Development, Sales, and Marketing
• Support cross-functional initiatives across the organization
• Contribute to team culture within Hematology/Oncology Medical Affairs

• Lead the medical strategy for the Cutaneous T-Cell Lymphoma disease area within Hematology Medical Affairs
• Drive brand medical strategy and external engagement with opinion leaders, community physicians, medical societies, and top accounts
• Lead launch preparatory efforts for lacutamab
• Serve as the lead medical voice for lymphoma and lacutamab
• Conceptualize and implement the US medical strategy for the disease area
• Report to the Vice President, Head of Hematology Medical Affairs
• Partner with Field Medical to engage healthcare professionals, medical organizations, payers, and patient advocacy groups
• Act as the medical lead on the Brand Team
• Own launch readiness, including disease education, unmet need articulation, and evidence generation planning
• Contribute analytic expertise and insights to Medical Affairs deliverables
• Develop KOL and key institution engagement plans
• Collaborate on field materials and tactics specific to CTCL and lacutamab
• Lead advisory boards and educational activities, including webinars, medical roundtables, symposia, and congress presence
• Generate and analyze medical insights to inform strategy and tactical adjustments
• Contribute to evidence generation projects, real-world evidence studies, and publications
• Build relationships with Market Access, Medical Information, Clinical Development, Sales, and Marketing
• Support cross-functional initiatives and contribute to team culture

• Lead the medical strategy for the Cutaneous T-Cell Lymphoma disease area within Hematology Medical Affairs
• Drive brand medical strategy and external engagement with opinion leaders, community physicians, medical societies, and top accounts
• Lead launch preparatory efforts for lacutamab, a humanized monoclonal antibody immunotherapy targeting KIR3DL2
• Serve as the lead medical voice for lymphoma and lacutamab
• Conceptualize and implement the US medical strategy for the disease area
• Report to the Vice President, Head of Hematology Medical Affairs
• Partner with Field Medical to engage healthcare professionals, medical organizations, payers, and patient advocacy groups
• Act as the medical lead on the Brand Team
• Own launch readiness for lacutamab, including disease education, unmet-need articulation, and evidence-generation planning
• Contribute analytic expertise and insights to Medical Affairs deliverables
• Develop and enhance KOL and key-institution engagement plans
• Collaborate on field-resource needs and development of field materials and tactics specific to CTCL and lacutamab
• Lead advisory boards and educational activities, including webinars, medical roundtables, symposia, and congress presence
• Generate, analyze, and share medical insights to inform strategy and tactical adjustments
• Contribute to evidence-generation projects, real-world evidence studies, and publications
• Build collaborative relationships with Market Access, Medical Information, Clinical Development, Sales, and Marketing
• Support cross-functional initiatives across the organization
• Contribute to a strong team culture within Hematology/Oncology Medical Affairs

• Establish and maintain trusted, scientifically driven relationships with KOLs, scientific experts, healthcare professionals and relevant medical societies within the territory
• Engage in high-quality, non-promotional scientific exchange and provide accurate, balanced and up-to-date medical information
• Develop and execute stakeholder engagement plans
• Gather, analyze and communicate relevant scientific and medical insights from the field
• Support planning and execution of advisory boards, investigator-sponsored studies, medical projects and congresses
• Collaborate with Medical Affairs, Clinical Development, Market Access and other cross-functional colleagues
• Represent Sobi at scientific congresses, symposia and external forums
• Maintain and expand knowledge of the therapeutic area

Director

• Develop and execute sales and access strategies for Sobi Rare Disease products
• Achieve assigned objectives for the region and assigned institutions, hospitals, and health systems
• Work cross-functionally to help ensure patient access to therapy in hospitals and other care settings according to product labeling
• Coordinate Sobi teams engaging health system stakeholders, including C-Suite leaders, P&T committees, Pharmacy Directors, and external experts
• Coordinate account-based activities with Market Access, Patient Services, and medical teams
• Share on-label scientific information translating into real-world clinical practice
• Educate clinicians on diagnostic criteria and testing options
• Build relationships with key decision makers and provide product and disease information supporting patient-care protocols
• Nurture and channel rare disease advocacy supporting label-consistent patient protocols
• Navigate Sobi products through influential pathways and engage C- and D-suite stakeholders
• Build relationships with thought leaders and identify next-generation KOLs through residency, fellowship, multidisciplinary-team, in-service, and educational programs
• Target, prioritize, clinically manage, and sell to physician and administration/leadership stakeholders
• Develop and execute business plans with cross-functional team members
• Develop and execute account plans based on national and regional strategies, including priorities, objectives, action plans, targets, network maps, and personnel coordination

Health Systems Director

• Maximize sales and reach sales targets based on customer insights for brands in the defined territory
• Develop and manage relationships with customers and stakeholders
• Develop and implement plans to secure sales targets
• Acquire marketplace knowledge for brands in the territory
• Gather and interpret market data and customer insights through stakeholder interaction and other sources
• Identify and assess market opportunities and decide tactics with the local team
• Share market knowledge and customer insights internally
• Execute and continuously revise regional and brand plans
• Analyze and follow up on sales, activities, and spending
• Initiate and execute customer activities
• Identify and interact with customers and relevant stakeholders
• Share best-practice initiatives
• Collaborate with Marketing, Medical, Patient Access/Engagement, Sales Force, Service functions, cross-functional teams, private practice-based treaters, and nurses

Therapeutic Specialist

Clinical Research

• Provide clinical, scientific and strategic input to clinical development plans for assigned sepsis programmes
• Define target populations, immune phenotypes/endotypes, biomarker-based enrichment strategies and clinically meaningful endpoints
• Evaluate adaptive, platform and Bayesian trial design options and document assumptions underpinning sample size and feasibility
• Collaborate on overall scientific and medical development strategy
• Act as clinical scientific lead for assigned Sobi-sponsored studies
• Where formally delegated and medically qualified, act as Medical Director/Medical Monitor
• Plan, design, conduct, medically monitor and report sponsored clinical studies
• Author clinical study protocols and clinical study reports
• Contribute to statistical analysis plans, informed consent templates and other core study documents
• Support feasibility in intensive care and emergency department settings
• Review emerging safety and efficacy data and support adverse-event attribution, safety review committee and DSMB interactions
• Participate in investigator meetings, site training and other study activities
• Support regulatory interactions, clinical submissions and responses to Health Authority questions
• Maintain awareness of regulatory guidance, precedent and expedited pathway options
• Engage key opinion leaders and support or lead advisory boards
• Represent Sobi at international conferences and scientific symposia
• Support engagement with scientific societies, research networks and patient advocacy organisations
• Provide expertise to Global Safety, Medical Affairs and Business Development
• Build knowledge in sepsis, critical care and immune dysregulation
• Develop relationships with cross-functional teams, local affiliates and collaborative partners
• Work according to applicable rules, regulations and internal procedures

Clinical Scientist, Sepsis

• Provide clinical, scientific and strategic input to clinical development plans for assigned sepsis programmes
• Define target populations, immune phenotypes/endotypes, biomarker enrichment strategies and clinically meaningful endpoints
• Evaluate adaptive, platform and Bayesian trial design options and document assumptions underpinning sample size and feasibility
• Act as clinical scientific lead for assigned Sobi-sponsored studies
• Where formally delegated and holding a medical degree, act as Medical Director / Medical Monitor
• Plan, design, conduct, medically monitor and report Sobi-sponsored studies
• Author clinical study protocols and clinical study reports
• Contribute to statistical analysis plans, informed consent templates and other core study documents
• Support operational feasibility in intensive care and emergency department settings
• Perform ongoing medical review of emerging safety and efficacy data
• Support adverse-event attribution, safety review committee and DSMB interactions, and interim analyses
• Participate in investigator meetings, site training and study-related activities
• Provide clinical development expertise in regulatory-authority interactions
• Contribute scientific and medical input to regulatory submissions and responses to Health Authority questions
• Maintain awareness of regulatory guidance and precedent relevant to acute critical care and sepsis trials
• Interact with key opinion leaders and support or lead advisory boards
• Represent Sobi at international conferences and scientific symposia
• Support engagement with scientific societies, research networks and patient advocacy organisations
• Provide expertise to Global Safety, Medical Affairs and Business Development when assigned
• Build knowledge in sepsis, critical care and immune dysregulation
• Develop relationships with cross-functional HQ teams, local affiliates and collaborative partners
• Work in accordance with applicable rules, regulations and internal procedures