Role Summary
Global Access Mechanisms (GAM), Strategy & Governance Lead within the Worldwide Medical organization. The role shapes and operationalizes Biogen’s global access strategy through a Center of Excellence focused on governance, capability building, and knowledge infrastructure for all global access mechanisms, including early, post-trial, compassionate use, and humanitarian programs. Responsible for long-term strategic planning and near-term execution to ensure access mechanisms are consistent, compliant, and scalable across geographies and therapeutic areas.
Responsibilities
- Develop and operationalize Biogen’s Global Patient Access Governance Framework, integrating ethical standards, decision pathways, and compliance requirements.
- Relaunch and optimize the Global Access Mechanism Governance Committee (GAM-GC), ensuring lean membership, clear decision rights, and escalation pathways.
- Harmonize SOPs and policy documents to support flexible, market-sensitive execution.
- Design and lead the Global Access Mechanisms Center of Excellence (CoE), including core principles, governance models, and content infrastructure.
- Translate a forward looking blueprint/roadmap into actionable initiatives that build and mature Biogen’s global access capabilities.
- Define and standardize access pathways including enablement value and risk profiles.
- Build and deliver high-impact training programs to enhance access competency across internal teams.
- Create and manage a centralized repository of access-related content, including policies, templates, and best practices.
- Monitor capability maturity and define KPIs to measure progress and impact.
- Tailor access strategies to market archetypes and legal/payor environments; integrate access planning into early clinical development; anchor access programs from regulatory submissions through reimbursement milestones.
- Be on-site in the Cambridge office on an ad hoc monthly basis to support priority meetings, workshops, stakeholder engagement, and cross-functional alignment.
Qualifications
- Required Skills:
- BSc/MSc in a scientific, clinical, or health policy-related field
- 10–13 years’ experience in biotech/pharma, focusing on access mechanisms, policy, or medical operations
- Proven experience developing governance frameworks, Centers of Excellence, or strategic capability models
- Deep understanding of global regulatory and ethical considerations related to patient access
- Experience working in a matrixed, cross-functional environment
- Preferred Skills:
- Background in medical affairs, value & access, or clinical operations
- Familiarity with capability maturity models and organizational development
- Exposure to global markets and diverse healthcare systems
Skills
- Strategic Execution: translate vision into structured frameworks and scalable tools
- Cross-Functional Collaboration: drive alignment across diverse teams and geographies
- Governance & Policy Expertise: knowledge of access-related regulatory and ethical frameworks
- Content & Knowledge Management: manage complex content ecosystems and training programs
- Analytical Thinking: assess gaps, define maturity models, and measure impact
- Adaptability & Learning Agility: navigate ambiguity and evolving priorities in a global environment
Education
- As listed in Required Skills: degree in scientific, clinical, or health policy-related field