Global LCM Senior Medical Director
- Lead the strategy of global medical-lead studies for Tolebrutinib, including the management of the study Steering Committee, development of the study results analysis and dissemination plan (primary and secondary results), interaction with global regulatory agencies and collaboration with the global operational and local medical teams to support study enrollment.
- Provides leadership to the Tolebrutinib life-cycle management strategy, perform yearly global data gap analysis and identifies needs for high value medical affairs driven studies and registries, and oversees their management and execution in accordance with established budgets and timelines.
- Develops medical strategies to obtain relevant evidence from Investigator Sponsored Studies, including Real World Evide nce (in collaboration with HEVA), consistent with data generation objectives for Tolebrutinib
- Support the Global Project and Regulatory teams to interact and respond to request from the global regulatory agencies (FDA, EMA and other agencies)
- Co-lead with the scientific communication head and leads the global data dissemination plan for Tolebrutinib, including publications and global congresses abstracts for the evidence generation pipeline.
- Collaborate with the Tolebrutinib Global Medical Directors for the definition of the Tolebrutinib global medical strategy and the execution of key global medical tactics (such as symposium, advisory boards, and field medical insights).
- Supports sharing of best practices between priority countries and others.
- Ensures a patient-centric approach to the development and execution of projects under your accountability.
- Adheres strictly to compliance rules, regulatory, access and ethical requirements.
- Minimum 10 years’ local/global experience in industry Medical or R&D, with solid track record of achievement in Medical Affairs in the biotech/pharma industry. Having launch experience is preferred.
- Suitable prior experience with global medical or clinical evidence generation activities, publications, scientific communications and experience within Neurology would be advantageous.
- Experience working in an international multi-country setting is preferred
- Significant line and matrix management experience, including strong transversal collaboration with key functions such as Research, Clinical Development, Scientific Communications, Commercial, Health Economics, Value and Access and Product Management functions.
- Strategic thinking: ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities. When under pressure, ability to bring others along to explain how strategic ideas fit into the larger context, and approach challenges thoroughly with a broad view, considering different potential outcomes.
- Result orientation: driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate potential issues.
- People Leadership: ability to lead through influence, inspire teams, engage and leverage everyone’s strengths while being highly self-aware. Set high standards and expectations, communicates proactively, collaborative and approachable and ability to provide meaningful feedback, coaching and support.
- Relationships and Influence: ability to empower and recognize others to create powerful relationships and networks. Effective stakeholder management, politically astute and role model teamwork and collaboration
- Highest ethical, regulatory and scientific standards
- Education: MD, PhD, PharmD, or equivalent scientific degree
- Languages: Fluent in English
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-GZ #LI-Onsite
#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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