The Development Real World Evidence Lead will work at TA with GPTs to launch high-impact program based on RWE science and technologies with an impact across TA and per GPTs The Development Real World Evidence Lead will favor interaction, synergy and actions for development of RWE project at development level with an impact across GPTs within the TA. Other internal partners such as DDS, CSO, Digital office and Global regulatory teams must be considered.
The Development Real World Evidence Lead will create a specific framework in order to design, collect and prioritize the projects. The Development Real World Evidence Lead will have to bring value by identifying the source of databases that could permit to launch new studies useful across TA level and the external strategic collaborations that could support the projects.
The Development Real World Evidence Lead will favour best in class practice for operational efficacy across the TA and GPTs and bring an added value by project management that favour successful collaboration, sharing of knowledge and skills, and permit alignment of the participants to a unique goal. The Development Real World Evidence Lead will have a role to disseminate the RWE team successes and developments inside Sanofi and to favour the internal visibility and adoption of RWE.
Create internal and external collaborations in order to identify, design, launch and execute new strategic RWE projects with an impact across the TA level and GPTs
Develop processes and best practices for high complexity RWE projects to be utilized across the TA
Alignment of the RWE generation strategy within the TA
Collaborate to Transform TAs/GPTs RWE outcomes into R&D impact initiatives (new indications, clinical operation efficiency improvements, label enhancement, label expansion, Co-Development projects, outcome based patient management)
Drive Due Diligence and Data Vigilance activities to monitor worldwide creation of high-quality datasets for TA Data acquisition activities
Interface with external partners to drive RWE and Machine Learning based initiatives for better definition of validated clinical endpoints
Derive maximum benefit from Development R&D RWE generation to allow Sanofi to accelerate regulatory approval working with GRA
Identify new RWE partnership requirements and cross-functional opportunities that bring innovative solutions and address key R&D RWE needs, including around new data sources, analytics capabilities, and technologies
Assess first feasibility studies and data sources identification in order to launch RWE collaboration that profit entire TA
Track deadlines, deliverables, resources, and timelines throughout the project process
Assess project delivery, completeness, and alignment with stated objectives and goals
Organize meetings with key stakeholders and ensure dissemination of results
Identify processes and activities to improve
Ensure global RWE governance processes are followed
This is a hybrid position, requiring he/she to visit the Cambridge, MA office two days a week.
Required educational background
PhD in Health Sciences
Experience in RWE, data analytics and statistics
Strong understanding of legal and regulatory environment influencing clinical development plans, labelling and promotional claim
Well-developed conceptual thinking skills with capability to access internal and external resources
Working in a global, matrix environment
Ability to interact externally with key customers
Persuasive communicator with a proven ability to work collaboratively in a multi-cultural environment
Effective project management experience
Innovative and out of the box thinking and excellent networking and influence skills
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.