Global LCM Senior Medical Director

Job Title : Global LCM Senior Medical Director

Location : Morristown, NJ Cambridge, MA

About the Job

This role is part of Global Medical Affairs team for Neurology within Specialty Care Medical Affairs. Our Medical Affairs function serves as key strategic partners for commercial, regulatory, R&D, market access and external affairs to develop and launch first in class and best in class therapeutic solutions that address highest unmet needs.

Within Global Medical Affairs Neurology, we are proud to support Sanofi's purpose of "Chasing the miracles of science to improve people's lives" and improve the health and lives of people with neurological disorders around the world.

Reporting to the Global Medical Lead for Tolebrutinib, the Global Senior Medical Director for Life Cycle Management (LCM) will oversee all data generation activities (phase IV interventional studies, RWE studies, ESR) for Tolebrutinib, from the strategy (data gap analysis, IEGP, study design) to the execution (contracting, study enrollment and follow-up, budget tracking). In addition, the LCM senior director will be the global medical point of contact for the GPT for LCM activities and will oversee, in close collaboration with the scientific communication head and directors, the scientific publication and communication strategy.

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities

A summary of responsibilities include :

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 Evidence (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.

About You

Experience

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.

Leadership skills

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

Technical skills

Education : MD, PhD, PharmD, or equivalent scientific degree

Languages : Fluent in English

Why Choose Us?

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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.