Global LCM Senior Medical Director

Role Summary

Global LCM Senior Medical Director leads data generation activities for Tolebrutinib, from strategy to execution, and serves as the global medical point of contact for LCM activities. Oversees publication and communication strategy in collaboration with scientific leadership. Role sits within Global Medical Affairs Neurology.

Responsibilities

• Lead the strategy of global medical-lead studies for Tolebrutinib, including study Steering Committee management, development of results analysis and dissemination plan (primary and secondary results), interaction with global regulatory agencies, and collaboration with global operational and local medical teams to support study enrollment.
• Provide leadership to the Tolebrutinib life-cycle management strategy; perform yearly global data gap analysis and identify needs for high-value medical affairs driven studies and registries; oversee management and execution within budgets and timelines.
• Develop medical strategies to obtain relevant evidence from Investigator Sponsored Studies, including Real World Evidence (in collaboration with HEVA), aligned with data generation objectives for Tolebrutinib.
• Support Global Project and Regulatory teams to interact with and respond to requests from global regulatory agencies (FDA, EMA, and others).
• Co-lead with the scientific communication head and lead the global data dissemination plan for Tolebrutinib, including publications and global congress abstracts for the evidence generation pipeline.
• Collaborate with Tolebrutinib Global Medical Directors to define global medical strategy and execute key medical tactics (symposiums, advisory boards, field medical insights).
• Share best practices between priority countries and others.
• Ensure a patient-centric approach to development and execution of projects within accountability.
• Adhere to compliance rules, regulatory, access and ethical requirements.

Qualifications

• Minimum 10 years‚Äô local/global experience in industry Medical or R&D, with a strong track record in Medical Affairs in biotech/pharma; launch experience preferred.
• Experience with global medical or clinical evidence generation activities, publications, and scientific communications; neurology experience advantageous.
• Experience in an international multi-country setting preferred.
• Significant line and matrix management experience with cross-functional collaboration (Research, Clinical Development, Scientific Communications, Commercial, Health Economics, Value & Access, Product Management).

Leadership Skills

• Strategic thinking: disrupt status quo with innovation while prioritizing pragmatic execution.
• Result orientation: develop and execute strategy aligned with objectives; manage ambiguity and adapt with agility.
• People leadership: influence, inspire, provide feedback and coaching; build strong teams and collaboration.
• Relationships and Influence: empower others, effective stakeholder management, politically astute.
• Highest ethical, regulatory and scientific standards.

Technical Skills

• Education: MD, PhD, PharmD, or equivalent.
• Languages: Fluent in English.