Jobs at Biogen

Leads clinical genetics and pharmacogenomics strategy across Phase I–III programs. Responsibilities include designing genetic testing strategies, advising on clinical trial protocols, interpreting genomic findings, managing testing vendors, addressing regulatory and ethical considerations, and translating clinical genetics insights into development, patient stratification, and reverse translational research decisions.

Leads quality assurance for clinical and commercial manufacturing at Biogen’s RTP site. Responsibilities include batch disposition, compliance oversight, quality systems management, audits, regulatory inspection support, quality metrics, continuous improvement, and CAPA, investigations, change control, and document management. The role manages and develops quality professionals, partners cross-functionally with Manufacturing and Engineering, and drives regulatory compliance and product quality.

Leads compliance and inspection readiness for a pharmaceutical drug substance manufacturing site. Oversees inspection management, data integrity, risk assessments, quality systems, regulatory responses, governance meetings, and quality metrics. Partners with site and global Quality teams to maintain cGMP compliance, resolve compliance gaps, support regulatory interactions, and drive continuous improvement across quality processes.

Manages and executes ITGC testing for SOX 404 compliance, including planning, walkthroughs, design and operating effectiveness testing. Reviews audit evidence and documentation, identifies control deficiencies, supports remediation, and coordinates with IT, risk management, SOX PMO, internal audit, and external auditors. Oversees junior staff, ensures testing quality and timelines, and supports IT audits, risk assessments, and internal audit initiatives outside peak SOX periods.

Leads the design, implementation, enhancement, integration, testing, and support of Veeva Vault RIM. Translates business requirements into functional specifications, manages application roadmaps, supports GxP compliance, mentors technical resources, oversees vendors, and drives system optimization. The role also handles data activities for mergers and divestitures, investigates emerging technologies, and partners with business and IT stakeholders to deliver reliable regulatory information management services.

Leads Biogen’s global clinical trial start-up and study activation strategy from protocol finalization through site initiation. Oversees activation teams, processes, systems, vendors, contracting, budgeting, EU-CTR strategy, compliance, and cross-functional delivery. Drives technology-enabled process improvement, performance visibility, talent development, and inspection-ready execution across regions and therapeutic areas.

Performs preventive and corrective calibration, troubleshooting, repair, and installation of manufacturing and laboratory instrumentation. Supports engineering, validation, manufacturing, and laboratory teams; maintains equipment in GMP and cleanroom environments; and authors updates to procedures, job plans, and LOTO safety forms. The role requires limited supervision, physical access to confined equipment areas, cleanroom gowning, and the ability to lift up to 50 pounds.

Provide high-level administrative support to an Executive Officer: manage complex calendars, coordinate leadership meetings and governance, draft executive communications, triage email, maintain org documents and SharePoint, arrange domestic and international travel, process expenses, provide in-person support for international strategic sessions, and collaborate with PO&T teams to drive initiatives and cross-organizational alignment.

Leads APAC corporate security, resilience, risk mitigation, business continuity, crisis management, product and supply chain security, travel security, event security, and executive protection programs. Provides regional strategic leadership, operational oversight, risk assessment, incident response, stakeholder engagement, and coordination with internal teams, external providers, and global program owners across geographically diverse manufacturing and commercial operations.

Senior immunology drug development leader serving as a strategic advisor and delegate to the unit head. Leads research-to-development transitions, early clinical development strategy, portfolio decisions, external innovation, business development, and venture investment assessments. Integrates scientific, clinical, regulatory, commercial, and strategic perspectives while aligning cross-functional teams, evaluating opportunities, guiding governance decisions, mentoring colleagues, and advancing programs from preclinical development through proof of concept.

Leads end-to-end clinical trial operations, including study strategy, protocol development, CRO oversight, risk mitigation, quality, timelines, budgets, and compliant execution. Chairs study management teams and coordinates cross-functional drug development activities across neurological and nephrology programs. Requires strong clinical operations leadership, GCP and ICH expertise, CRO management, project management, and scientific knowledge.

Leads and develops a regional neuropsychiatry sales team supporting postpartum depression treatment. Responsibilities include recruiting and onboarding account managers, coaching for performance, executing strategic priorities, managing stakeholder relationships, understanding market dynamics, supporting talent development, and ensuring promotional compliance. The role requires specialty pharmaceutical sales leadership, launch experience, significant travel, and residence within the Southeast region.

Leads pharmacovigilance activities for assigned products, including signal detection and management, literature reviews, safety inquiries, and aggregate reports such as PSURs, DSURs, REMS, and RMPs. Collaborates on clinical trial safety activities, regulatory responses, data analysis, and cross-functional product information sharing. Serves as a subject matter expert on global safety regulations and may hire, train, and mentor product-specific staff.

Execute end-to-end sourcing and contracting activities for meetings and events, including RFx events, supplier interactions, contract completion, documentation, compliance, and operational supplier performance. Partner with stakeholders, ensure quality and audit readiness, and implement process improvements. The role requires strong organization, communication, procurement expertise, and proficiency with Microsoft Office in a hybrid Warsaw-based environment.

Leads Biogen North America’s commercial strategy, operational excellence, strategic planning, cross-functional initiatives, and new product commercialization. Develops multi-year and annual strategies, improves governance and processes, supports executive business reviews, oversees late-stage pipeline launch readiness, builds commercialization capabilities, and supports M&A integration. Requires strong pharma commercial expertise, stakeholder management, matrix leadership, and program execution skills.

Performs pharmacovigilance signal management, safety data evaluations, literature reviews, and aggregate safety report authoring, including PSURs, DSURs, and Risk Management Plans. Collaborates with clinical safety teams, supports investigational programs, coordinates regulatory responses, and contributes to process improvements. The role requires interpreting scientific and medical data, applying global safety regulations, and leading projects independently while working cross-functionally in a hybrid Maidenhead office setting.

Leads global commercial supply operations for a biotech/pharmaceutical organization, including third-party packaging, labeling, and logistics partners. Oversees supplier governance, 3PL performance, inventory control, launch readiness, contracts, compliance, serialization, DSCSA requirements, risk mitigation, and continuous improvement. Manages teams and cross-functional initiatives while ensuring supply continuity, quality, service, and cost objectives. Requires extensive pharmaceutical supply chain leadership experience and occasional supplier travel.

Leads global strategic sourcing for Marketing and Sales, managing complex sourcing initiatives, negotiations, supplier selection, contracts, supplier performance, cost modeling, risk, compliance, and process improvements. Partners with stakeholders, Legal, and category managers to deliver savings, commercial value, social responsibility, and governance outcomes across assigned categories or regions.

Leads rare disease brand strategy, integrated planning, performance management, forecasting, budgeting, launch readiness, lifecycle initiatives, and cross-functional execution. Translates market, patient, competitive, access, and financial insights into growth opportunities and investment decisions. Partners with Sales, Medical, Market Access, Finance, Regulatory, Supply, and other stakeholders while addressing diagnosis, treatment, and care-continuity barriers in Brazil.

Provides strategic clinical quality and compliance leadership across R&D, including QMS governance, clinical study oversight, risk management, investigations, CAPA, vendor quality governance, audits, regulatory inspections, and continuous improvement. Advises cross-functional teams on GCP and global regulatory requirements while strengthening inspection readiness, data integrity, patient safety, and quality performance.