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 designing and 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 organizations to 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 ensuring all evidence generation activities comply with regulatory requirements, Good Clinical Practice (GCP), and company policies.
In charge of implementing quality assurance processes to maintain the integrity and credibility of generated evidence.
In charge to monitor and manage budgets, timelines, and resources for evidence generation projects.
About You
Desired Skills and Competencies
Demonstrated exceptional experience in clinical research, medical affairs, and real-world evidence generation.
Demonstrated experience and knowledge of clinical trial design, biostatistics, and data analysis.
Demonstrated experience and proficiency in 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 demonstrating expertise 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.
