Clinical Development RWE Portfolio Head

Sanofi•Morristown, MA

1d•Hybrid

About The Position

Reporting to the Global Head of Clinical Development RWE, the Clinical Development RWE Portfolio Head (CDRPH) will work across functions and therapeutic areas to drive a portfolio of RWE projects, leveraging RWE platforms, data and assets and coordinate project Leads to drive evidence generation needs across clinical development. The CDRPH will drive development of RWE projects based on evidence needs for clinical development and current/future molecule pipeline, coordinating with platform heads and project Leads. The CDRPH will manage multiple RWE evidence programs, driving the projects strategy and interfacing with key clinical development stakeholders. He/She will manage Leads priorities and roadmap to focus on highest impact and overall company priorities. He/She will also work in close contact with other internal partners such as DDS, CSO, Research, Digital office and Global regulatory teams to ensure need and ambition of TA is fulfilled. The CDRPH will work closely with the Clinical Development RWE Strategic Platform Heads (CDRSPH) to inform the platform’s roadmap, prioritize key projects, assess dependencies and implications for other projects and platforms. The Clinical Development RWE Portfolio Head will collaborate with teams in the Translational Medicine Unit/ and across relevant therapeutic Areas, engage with research and development assets and program leads to support TMU programs by providing and generating new RWE insights. CDRPH will oversee the creation of specific frameworks to design, collect and prioritize projects for specific RWE platform. He/She will have to bring value by ensuring continuous involvement with clinical teams in leveraging the RWE evidence, all the way to publication, regulatory submission and other critical development activities. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

Minimum Education: PhD in Health Sciences or related field
Minimum Experience : 3 years experience in Real World Evidence required.
Proven capability to deliver complex RW projects to support clinical development or regulatory decision making.
Experience in relevant therapeutic area preferred.
Well-developed conceptual thinking skills with capability to access internal and external resources.
Experience working in a global, matrix environment.
Excellent communication skills, with 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.
Proven leadership and stakeholder management skills
Innnovative and out of the box thinking and excellent networking and influence skills
Strong understanding of TA context (related to Sanofi pipeline), current needs and latest innovations in clinical development.
Experience in RWE, data analytics and statistics.
Strong understanding of legal and regulatory environment influencing clinical development plans, labelling and promotional claim.
Past experience / excitement around big data / modern tech stack environment.

Responsibilities

Identification of clinical needs from RWE projects across functions and relevant TAs: Work collaboratively with GPTs, RWE Leads and other key stakeholders to identify RWE Clinical development needs and organize response to relevant requests for support. Frame RWE generation activities in line with Clinical Development strategy.
RWE platform strategy across functions and relevant TAs: Develop a project specific roadmap for each project in the portfolio, contribute to the broader RWE organization and platform strategy. Lead a comprehensive data strategy for R&D access to best-in-class datasets, for respective portfolio, in collaboration with relevant Sanofi stakeholders. Ensure access modalities to fit-for-purpose datasets, in collaboration with relevant Sanofi stakeholders in relevant TAs. Have external facing interactions to drive adoption of RWE in clinical development, at FDA/EMA level. Drive interaction with external policy groups in collaboration with Regulatory function: Drive Real World Evidence Generation to Support Clinical Development Plans. Manage Clinical Development RWE Analytical/Study leads to operationalize response to platform needs in clinical development. Ensure proper dissemination and use of study outputs to best support Clinical Development objectives.
Manage and contribute to development of RWE Leads: Oversee RWE Leads involved in various RWE projects related to RWE evidence generation platforms. Contribute to building a community of project Leads and RWE analytics translators to deliver evidence platform projects.