Clinical Development RWE Portfolio Head

Sanofi; Morristown (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

Sanofi in Cambridge, MA seeks a Clinical Development RWE Portfolio Head to drive a cross-functional program of real-world evidence projects and coordinate with platform heads to prioritize high-impact initiatives. The role interfaces with regulatory teams and RWE analytics partners to deliver insights that support development plans.

The ideal candidate has a PhD in Health Sciences and 3+ years of Real World Evidence experience, with strong leadership and communication skills in a global matrix

Qualifications

• PhD in Health Sciences or related field.
• 3 years experience in Real World Evidence required. Proven capability to deliver complex RW projects to support clinical development or regulatory decision making.
• Excellent communication skills and ability to interact externally with key customers.
• Strong understanding of TA context, current needs and latest innovations in clinical development.

Responsibilities

• Identify clinical needs from RWE projects across functions and relevant TAs; collaborate with GPTs, RWE Leads to identify needs and respond to requests.
• Frame RWE generation activities in line with Clinical Development strategy.
• Develop project roadmaps for each project in the portfolio and contribute to platform strategy.
• Lead data strategy for R&D access to datasets and ensure proper access modalities in collaboration with stakeholders.
• Drive external interactions to promote adoption of RWE in clinical development at FDA/EMA level.
• Oversee RWE Leads involved in various projects and build a community of leads and analytics translators.

Skills

RWE analytics

Stakeholder management

Project leadership

Communication

Global matrix environment

Education

PhD in Health Sciences

Tools

RWE platforms

Data analytics

Statistics

Job description

Location: Cambridge, MA

Job title

Clinical Development RWE Portfolio Head

Location: Cambridge, MA

About The Job

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.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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.

About You

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.

Soft Skills

• 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

Technical 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.

Languages

• 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.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.