Jobs at Sobi

Lead US regulatory strategy for assigned development and marketed products. Serve as US point of contact with FDA, prepare and lead major meetings, develop risk/mitigation plans, drive use of expedited pathways, support IND/NDA/BLA submissions, collaborate cross-functionally and with consultants, and monitor US regulatory environment.

Lead international cross-functional CMC and technical operations teams to deliver Module 3 NDA documentation. Manage program plans, timelines, budgets, risks, document reviews, governance presentations, and vendor/CMO interactions to ensure on-time, on-budget regulatory submissions.

Serve as primary customer contact to drive sales and execute marketing strategy for hematology biologics. Provide clinical product knowledge, develop territory business plans, meet/exceed sales targets, represent Sobi at local meetings, manage specialty pharmacy and reimbursement processes, report adverse events, and complete required administrative duties.

Regional Account Director acts as the field market-access lead for a defined Northeast region, engaging payers, PBMs, IDNs, and oncology accounts to secure formulary placement, shape payer policy, negotiate access solutions and contracts, support launches, drive cross-functional pull-through, and report on contract performance to increase patient access for SOBI's rare-disease portfolio.

Serve as the analytics lead for Market Access, translating payer, formulary, contracting, channel, and patient journey data into KPIs, dashboards, and executive-ready insights. Own dashboard design in Tableau, lead QBRs, partner cross-functionally, and provide strategic analytics guidance to market access and field teams to inform access, contracting, and affordability strategies.

Lead global regulatory advertising & promotion strategy and the AdPromo team, own the global material review process, manage FDA OPDP/APLB interactions, provide regulatory advice across product lifecycle, develop SOPs, train stakeholders, and ensure compliant, timely promotional and corporate communications for Sobi products.

Lead cross-functional project management for pharmaceutical product launches, building and maintaining integrated Smartsheet plans, identifying and mitigating risks, communicating status to stakeholders and senior leadership, and driving operational excellence and continuous improvement to ensure on-time commercialization.

Lead and manage the company's ethics and compliance programs, focusing on transparency reporting, compliance training, auditing and monitoring, corrective actions, and stakeholder guidance. Partner with global compliance teams, maintain regulatory awareness, ensure accurate reporting and timely submissions, and support HCP/HCO engagement compliance and related operational processes.

Lead and operationalize a repeatable North America launch excellence framework for rare-disease products. Drive cross-functional launch readiness, governance, milestone tracking, risk management, data-driven decision-making, and continuous improvement to ensure on-time, high-quality commercial launches and strong patient impact.

The Clinical Account Manager is the primary customer contact for territory sales and demand creation, delivering on-label clinical messaging, executing territory business and POA marketing plans, representing Sobi at meetings, and achieving sales targets. Responsibilities include territory planning and budgeting, physician targeting and reporting, ensuring regulatory compliance, reporting adverse events, and performing administrative tasks (call reporting, expenses). Significant travel within the territory (up to 40-50%) is required.

Lead a regional hematology commercial team to achieve sales goals, coach and develop field staff, execute launch and market strategies, collaborate cross-functionally, track KPIs, ensure regulatory compliance, and drive customer and product performance across the Mid-Atlantic region.