RWE Project Lead, Clinical Insights

BioSpace; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi in Cambridge, MA, is seeking a Clinical Development RWE Project Lead to drive real-world evidence programs across therapeutic areas. You will lead cross-functional teams, design data-driven strategies, and ensure alignment with regulatory expectations within our EGDS organization.

Successful candidates will have 2+ years in real-world/clinical projects, strong project management, and deep understanding of RWE, data analytics and regulatory considerations.

Qualifications

• PhD, or MSc, in Health Sciences with quantitative background or Public Health.
• Minimum 2 years of previous experience in Real World/clinical project in industry.
• Understanding of TA relevant to Sanofi context (such as I&I, Neuroscience or rare diseases).
• Understanding of RWE, data analytics and statistics.
• Understanding of legal and regulatory environment influencing clinical development plans.

Responsibilities

• Lead multidisciplinary teams and manage project execution timelines.
• Coordinate with RWE portfolio Heads, GPTs and other stakeholders to design project MVP goals and deliverables.
• Create project business cases, document and report project activities and define system requirements and dependencies.
• Ensure access modalities to fit-for-purpose datasets in collaboration with Sanofi stakeholders.
• Drive external interactions to promote RWE adoption at FDA/EMA levels.

Skills

RWE knowledge

Project management

Statistical analysis

Regulatory awareness

Stakeholder management

Leadership

Communication

Education

PhD or MSc in Health Sciences

Tools

Big data tech

AI platforms

Job description

Sanofi in Cambridge, MA, is seeking a Clinical Development RWE Project Lead to drive real-world evidence programs across therapeutic areas. You will lead cross-functional teams, design data-driven strategies, and ensure alignment with regulatory expectations within our EGDS organization.

Successful candidates will have 2+ years in real-world/clinical projects, strong project management, and deep understanding of RWE, data analytics and regulatory considerations.