Medical Director – Global Medical Evidence Generation, Immunology

Job Title: Medical Director – Global Medical Evidence Generation

Location: Cambridge, MA

About the Job

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.

Medical Director – Global Medical Evidence Generation supports disease registries, post-regulatory authorization clinical trial programs, RWE and epidemiological studies for Next-Gen Immunology pipeline assets. The Medical Director will report directly to Global Medical Evidence Generation Lead, Next-Gen Immunology Franchise and will be responsible for operational excellence of the phase IV studies (clinical and RWE), refreshing IEGPs annually and operationalizing the tactical activities from the IEGP.

With guidance from the Global Medical Evidence Generation lead, the new director will be an integral part of executing the global medical evidence strategy in line with the IEGPs developed for pipeline assets supporting development and preparation for the launch and post launch activities. The exceptional new hire will have strong expertise in designing and executing epidemiological studies, phase IV clinical studies and RWEs utilizing latest tools and technologies with a working knowledge and background in R&D and/or Medical Affairs. Expertise in immunology-inflammation space is desirable.

Main Responsibilities

Provide strategic and operational input into clinical development plans and post-marketing studies to ensure robust evidence generation.

Accountable for designingand overseeing the execution of phase IV clinical trials, observational studies, and real-world evidence (RWE) studies.

Ensure the generation of high-quality, scientifically rigorous evidence to support the safety, efficacy, and value of our products.

Lead the development of study protocols, statistical analysis plans, and clinical study reports.

Oversee the analysis and interpretation of clinical and real-world data to generate meaningful insights.

Ensure the accurate and timely dissemination of study results through publications, presentations, and regulatory submissions in collaboration with SciCom team.

Stakeholder Engagement

Build and maintain relationships with selected Global Key Opinion Leaders (KOLs), academic institutions, and research organizationsto identify evidence gaps and opportunities for collaboration.

Act as a representative of evidence generation team from Sanofi at scientific conferences, advisory boards, and regulatory meetings.

Collaborate with biostatisticians, data scientists, and external partners to leverage advanced analytics and innovative methodologies.

Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs, HEVA, Market Access, and Commercial to align evidence generation activities with medical objectives.

Compliance and Quality Assurance

Accountable for ensuringall evidence generation activities comply with regulatory requirements, Good Clinical Practice (GCP), and company policies.

In charge of implementingquality assurance processes to maintain the integrity and credibility of generated evidence.

In charge to monitorand manage budgets, timelines, and resources for evidence generation projects.

About You

Desired Skills and Competencies

Demonstratedexceptional experience in clinical research, medical affairs, and real-world evidence generation.

Demonstrated experience andknowledge of clinical trial design, biostatistics, and data analysis.

Demonstrated experience and proficiencyin regulatory requirements and guidelines for clinical research and evidence generation.

Proven ability to lead and manage cross-functional teams in a global environment.

Excellent project management skills with the ability to prioritize and manage multiple projects simultaneously.

Exceptional written and verbal communication skills

Strong interpersonal skills with the ability to build and maintain relationships with internal and external stakeholders.

Strong analytical skills with the ability to interpret complex data and generate actionable insights.

Creative problem-solving skills with a proactive approach to identifying and addressing challenges.

High ethical standards and commitment to maintaining the integrity of scientific research.

Strong attention to detail and commitment to quality.

Qualifications Required

MD plus related MSc/MPH or PhD in Epidemiology/Public Health, or equivalent advanced degree in a relevant field.

Minimum of 5 years of experience in clinical research, RWE/Epidemiology, medical affairs, clearly demonstratingexpertise in developing RWE/epidemiological studies, as well as study management and publications.

Prior experience in clinical trials, RWE/Epidemiological studies including understanding of trial methodology, design, management, and execution.

Demonstrated experience in leading global evidence generation initiatives as well as study management and publications.

Professional fluency 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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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi – YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)