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 l