The Medical Manager, Rare Disease - Iberia is responsible for leading medical strategy and activities for the Biogen SMA ( Spinal Muscular Atrophy) disease portfolio.
What You'll Do Strategic leadership Provide medical input into regional / global medical strategy for SMA leveraging local customer insights, working cross-functionally with key internal partner functions to address the medical SMA needs in Spain.
Lead, develop and implement country SMA medical plans, partnering with the affiliate leadership team across functions to define, establish and execute a coherent local strategic plan that addresses SMA patient needs.
Participation in business planning processes, identifying key RWE research questions and ensuring targeted and innovative solutions, aligned with the product strategy.
Coordinate medical team (with no direct reports) to ensure full alignment with global/regional strategy and support better understanding of current local challenges, clinical practice and diagnosis needs for SMA patients.
Partner and collaborate with market access to show potential medical value of compounds in development relevant to local external stakeholders (payers, HCPs, agencies).
Develop and execute phase IV studies, registries, IITs and SRAs for SMA, as required.
Maintain up to date clinical knowledge and provide appropriate strategic and operational input into SMA portfolio objectives.
Support regulatory strategies for product specific activities.
Work closely with cross functional colleagues including commercial teams to create and drive medical product tactics that can enhance SMA patient well-being and that deliver value to both patients and their healthcare teams.
Collaborate with national Governmental and Corporate Affairs team to develop and implement a communication strategy.
Collaborate with Global Clinical Operations and CCL on early phase trials in the SMA pipeline, phase III, and later phase IV activities (including site and PI selection).
Develop and manage budgets for SMA medical activities and provide input into the affiliate budgeting and planning process.
Build local medical science expertise of the Biogen SMA Portfolio.
Facilitate sharing of best practices and knowledge across products and locations (training internally).
Facilitate medical information request process (MedInfo), patient support program (PSP), patient advocacy groups and care givers advocacy groups, as appropriate.
Manage an external medical expert network to ensure relevant and appropriate integration of accruing external medical expertise for Spain.
Build high value-added continuous medical educational programs in SMA for external stakeholders.
Coordinate medical review of country-specific SMA materials to ensure scientific accuracy when needed and clearly express rationale for any objection and sign-off before release.
Provide medical perspective and knowledge to other SMA teams within the affiliate and at regional / global level.
Leadership of cross-functional product teams and close collaboration with legal, quality and compliance, ensuring all regulations and contractual requirements are in place.
Create a climate in which self-motivated individuals will aspire to higher levels of performance.
Ensure exchange of medical information with other functions as appropriate for medical affairs and behave as a role model.
Identify lifecycle development opportunities for SMA products based on patient needs.
Qualifications Who You Are You are a highly skilled professional with a strong focus on scientific exchange, excelling in building impactful interactions with top-tier thought leaders, physicians, patient organizations, and internal stakeholders.
Your ability to communicate complex scientific concepts clearly and effectively allows you to tailor information appropriately to different audiences, whether addressing affiliate staff or global Medical Affairs leadership.
You prioritize relationship-building, fostering meaningful connections with both internal teams and external stakeholders to drive collaboration.
Additionally, your expertise in process management ensures successful project execution, people management, and measurable success outcomes.
Required Skills Strategic & business acumen: Excellent understanding of strategic/business needs of the affiliate organization and the SMA portfolio.
Scientific acumen: Hold 'peer to peer' relationships with top tier SMA thought leaders.
Understanding external and internal RWE requirements key to payers, regulators and physicians in the immediate, mid- and long-term.
Statistical & data interpretation: Required for review and support of medical information.
Medical writing as required.
Experience in reviewing and approving promotional and non-promotional materials and familiar with the relevant pharmaceutical codes of practice.
Experience of operating as a final medical signatory.
Qualifications required for the role 3-5 years' experience within a medical affairs role in Pharmaceutical industry.
Experience in the Rare Disease/Neurology area would be an asset.
Ability to communicate and work in English/Spanish.
Portuguese language would be an asset.
Knowledge and understanding of disease area, local health care system / market dynamics, regulations, policies and SOPs, health economic techniques and trends.
Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments.
Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job level.
30-40% time in-field.
Based in Madrid.
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