Global Medical Evidence Generation Lead - Hemophilia

Job Title :

Global Medical Evidence Generation Lead - Hemophilia Portfolio

Location : Cambridge, MA / Morristown, NJ

About the Job

This role reports into the Global Medical Head of Hemophilia; that is part of the Global Rare Disease Medical Team. Our Medical Affairs function serves as a key strategic partner with commercial, regulatory, clinical, HEVA and market access on therapeutic solutions to support patients' needs.

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 :

Oversee all data generation activities (phase IV interventional and observational studies, RWE studies, ISS and external collaborations) for product(s) in scope in Hemophilia, from the strategy (data gap analysis, study design) to the execution (study enrollment, budget tracking, etc).

Collaborate with cross functional partners as appropriate

Support on regulatory submission and interaction with global regulatory agencies

Support alliance relationship as needed

Support institutional research relationship as needed

Lead the execution and support the strategy of global Medical Affairs studies, including the management of the study Steering Committee, development of the study results analysis and dissemination plan (primary and secondary results), collaboration with the global operational and local medical teams to support study enrollment

Provides leadership to the life-cycle management strategy, performs yearly global data gap analysis and identifies needs for high value medical affairs driven studies and other evidence generation related activities, 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, consistent with data generation objectives

Supports regulatory interactions and respond to request from the global regulatory agencies (FDA, EMA and other agencies) as required and appropriate

He / she will aim to manage programs in an innovative, digital, and effective way

Supports sharing of best practices between priority countries and others

Ensures a patient-centric approach to the development and execution of projects under his / her accountability

Adheres strictly to compliance rules, regulatory, access and ethical requirements

About You

Experience :

MD, PhD, or PharmD preferred, with expertise in Rare Hematologic Disorders

Minimum 5 years' experience in industry Medical or R&D, with solid track record of achievement in Medical Affairs in the biotech / pharma industry.

Suitable prior experience with global medical or clinical studies; experience within hemophilia or rare diseases would be advantageous.

Experience working in an international multi-country setting is definitely a plus.

Soft 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

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.