Director, Real World Investigator- Cambridge, MA
Cambridge, Massachusetts, Bridgewater, New Jersey
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The Real World Evidence and Clinical Outcomes (RWE&CO) function mission is “To improve patient outcomes by generating the evidence required by healthcare decision makers to support patient access and use of sanofi medicines and the insights required by Sanofi internal teams to develop and commercialize the most impactful medicines”
A Real World Investigator is a high-level, strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and efficient real world evidence strategy for drug and enablement projects at a global level. The incumbent has deep knowledge, extensive experience and provides essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact project opportunities and risks. The role holder leads development of consensus among diverse scientific, technical, and business experts (often at the global level) so as to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs
These responsibilities require an extensive experience in the pharmaceutical industry with broad and deep knowledge of RWE activities and how they relate to product development and commercialization processes at all life-cycle stages. The successful candidate will be able to demonstrate strong leadership capabilities.
Job Duties and Responsibilities
A Real World Investigator will work independently in the design, execution, analysis, interpretation, and internal and external communication of specific epidemiological/outcomes research studies. This role requires taking a leadership role in a range of activities, e.g.:
- Deliver highly experienced strategic input, epidemiological/outcomes research support, and leadership to project teams and the Real World Evidence Team during all stages of pharmaceutical development to maximize the market potential of Sanofi products, manage risks, and optimize epidemiological processes and methods.
- Deliver specialized research to enhance the effectiveness of real world evidence contributions to world-wide submissions and the drug research process including discovery, development and commercialization across a broad range of products
- Effectively negotiate with and strategically influence senior leadership (e.g., Department or Therapy Area leaders) as well as a wide range of project teams
- Provide innovative thinking regarding the design of clinical and epidemiological/outcomes research programs and commercialization
- Set standards for utilization of real world evidence, provide methodological leadership and input to real world evidence strategies
- Identify and validate external data sources
- Develop relationships with international opinion leaders and collaborative groups to enhance the standing of the Real World Evidence Team and Real World Evidence Investigators in the external scientific/academic community
- Provide strategic guidance to the Real World Evidence Team and to the company in a specific epidemiological/outcomes research area of expertise, and typically, in a specific therapy area.
Required Educational Background and Job-Related Experience
- Doctoral degree preferred in epidemiology, public health, outcome research or related field
- Master’s degree in epidemiology, public health, outcome research or related field
- Comprehensive knowledge of clinical and commercial drug development processes
- At least 3 years of experience in the pharmaceutical industry or in closely related academic epidemiological/outcomes research.
- Sustained productivity in epidemiological/outcomes research as manifest by successful design, execution, and publication of original research relevant to drug discovery and development (e.g., drug safety) or commercialization in peer-reviewed journal
- Experience in utilizing secondary data and also conducting primary data collection studies
- Emerging recognition by the external scientific communities as an expert in the application of epidemiology/outcomes research to areas relevant to drug development and commercialization
- Sustained record of productivity at a strategic as well as an operational level
- Able to effectively engage and consult with recognized key external scientific expert
Skills and Capabilities
- Knowledge of RWE and its application to support pharmaceutical development , regulatory approval and patient access at an international level
- Experience in the pharmaceutical industry, with knowledge of regulatory, payer, and HTA requirements from a global perspective and product development processes at all life-cycle stages
- Understand product development processes at all stages of the life cycle in order to influence the appropriate use of RWE activities
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
- Good problem solving and conflict resolution skills
- Dedicated team player
- Requires high level of interactive communication including challenges to conventional thinking as necessary
- Expert communication skills
- Able to influence others across the business in order gain commitment to strategy
- Proven teamwork and collaboration skills
- Well-developed cultural sensitivity
- Effectively represents the company externally to key stakeholders
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.
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.
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