Jobs at Sobi

Field-based senior Clinical Account Manager responsible for developing and executing territory and key account plans in nephrology and hematology. Build KOL relationships, drive product uptake, coordinate cross-functional teams, analyze territory performance, support speaker programs, and achieve or exceed sales targets while ensuring compliance with corporate and regulatory guidelines.

Design, build, and maintain enterprise-grade AI-enabled full-stack applications on Azure. Implement document processing (RAG), chat interfaces, and real-time collaboration using Next.js, React, and TypeScript. Integrate Azure services (OpenAI, Cosmos DB, Cognitive Search, Blob Storage), optimize LLM usage, ensure GxP-compliant code quality and security, and collaborate with ServiceNow to resolve issues.

Lead global brand communications for Tryngolza: develop and execute launch and lifecycle strategy, manage media and congress communications, enable affiliates with toolkits, oversee agency partners, ensure compliance, drive insights and KPIs, and build capabilities including AI-enabled tools.

The Clinical Account Manager is a territory-focused commercial leader promoting Sobi hematology products. Responsibilities include executing marketing and POA strategies, driving sales to target, educating healthcare professionals on clinical benefits, managing budgets and local events, ensuring regulatory compliance, reporting adverse events, maintaining CRM/call reports, and frequent travel within the territory to grow accounts and support patient transitions from hospital to outpatient care.

The Clinical Account Manager promotes Sobi hematology products to healthcare professionals, drives territory sales through POA marketing strategies, builds territory business plans, manages physician targeting and budgets, ensures compliance and adverse event reporting, handles administrative CRM and expense tasks, and travels within the territory (up to ~40-50%).

Provide QA oversight for analytical activities and stability studies for products where Sobi is MAH. Approve GMP-related analytical methods, review deviations/CAPA/change controls, manage quality agreements with CROs/CLOs, approve specifications and critical analytical materials, support regulatory/CMC analytical issues, and author/approve SOPs and related documentation to ensure compliant release and stability testing.

Lead integrated end-to-end supply planning across short-, mid- and long-term horizons for drug substance, product and finished goods. Drive scenario planning, risk assessments, allocation/prioritization, capacity and inventory requirements. Partner cross-functionally (Commercial, Medical, TechOps, Quality, Regulatory, Distribution) to present risks, recommendations and KPIs to governance and senior stakeholders, and continuously improve planning tools and processes.

Manage device and application lifecycles in a Microsoft cloud environment: enroll and configure devices in Intune, package and deploy applications, monitor health and troubleshoot Windows and iOS, coordinate incidents/changes in ServiceNow, serve as SME, train ServiceDesk, and drive continuous improvement.

Manage international and national congress participation for hematology and haemophilia business units: plan events, coordinate internal and external stakeholders, manage budgets and vendor contracts, ensure regulatory compliance, maintain records, and support contract management processes.

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 nephrology launch readiness and diagnostic strategy, coordinating cross-functional teams (Commercial, Medical, Market Access) and affiliates to drive disease awareness, patient identification, referral pathways, toolkits, training, KPIs, and compliant stakeholder engagement to enable timely adoption and reimbursement.

Sell and promote Sobi hematology products to hospital and specialty customers within Ft. Myers territory. Build territory business plans, meet sales targets, manage physician engagement, ensure regulatory compliance, report adverse events, handle reimbursement/formulary issues, and perform administrative reporting. Frequent travel within territory (up to ~40-50%).

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.

Lead product quality activities across the product lifecycle, ensuring GMP/GDP compliance, supporting tech transfers and submissions, managing audits/inspections, driving complex quality changes, coordinating QA across markets, supporting recalls, and guiding quality aspects during integrations and due diligence to ensure uninterrupted drug supply.

Lead transition from paper-based processes to a compliant electronic Quality Management System (eQMS). Manage quality systems (document control, training, deviations, CAPA, change control, audits), ensure GxP and regulatory compliance (GLP/GCP/GMP, FDA/EMA), support inspection readiness and regulatory submissions, validate computerized systems, oversee vendor oversight, and provide cross-functional quality leadership and training across drug development lifecycle.

Support and coordinate pre-launch market access activities in Germany (AMNOG/EU-HTA). Prepare reimbursement dossiers, coordinate cross-functional teams and external partners, engage KOLs, support G-BA consultations/hearings, propose HEOR/RWE studies, and align pricing and access strategies with global and local stakeholders.

Lead global omnichannel strategy and execution for HCP and stakeholder engagement across channels. Develop customer journeys, oversee content and campaign deployment, set KPIs, enable affiliates with playbooks and training, enhance HCP portal, collaborate cross-functionally, and evolve digital capabilities to drive brand impact and topline growth while ensuring regulatory compliance.

Lead international cross-functional CMC and technical operations teams to deliver NDA Module 3 documentation. Manage program plans, timelines, budgets, risks, and document review; prepare governance materials; coordinate CMOs/partners; drive decisions and accountability to ensure on-time, on-budget regulatory submissions.

Provide QA oversight for GCP/GCLP/GPP activities across clinical studies, manage end-to-end GCP audit program, assess deviations and CAPAs, support inspection readiness, qualify GCP service providers, author and review QA processes, produce audit and quality metrics, and act as QA representative during inspections and cross-functional initiatives.

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.