I - Job Summary
Reporting to the Head of Real-World Evidence (RWE), the RWE Engagement Lead Switch & NA will liaise with the Evidence Generation leadership, global /regional categories /subcategories, Switch teams, and other functions in the global business unit (GBU) in development of comprehensive strategic plans for RWE based scientific evidence. The RWE Engagement Lead Switch & NA will ensure successful execution of the studies by coordinating with the global, regional, and country medical leads, medical operations and program leads, regulatory, chief digital office (CDO) RWE hub, advanced analytics, as well as external partners including, vendors, institutions, and experts including the key thought leaders. The RWE Engagement Lead will ensure successful delivery of studies based on agreed timelines and budget while ensuring high quality and scientific conduct of the studies. They will also ensure delivery of internal projects for addressing internal business needs and facilitate translation of findings into insights for internal and external communication. He/she will participate in the Science Hub and other cross-functional teams in the GBU to ensure alignment of real-world medical evidence with the strategic priorities cross-functionally and serve as an expert resource regarding RWE for other functions within the GBU.
II – KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS
Knowledge and Skills:
Serve as the primary contact for real-world evidence expertise in the Science Hub and cross-functional teams within the global /regional categories/ subcategories and Rx to OTC Switch teams.
Facilitate the strategic planning process for real-world studies with global medical leads and cross-functional colleagues by identifying data gaps and evidence needs that are aligned with the priorities and strategic plans for medical and GBU.
Inform the feasibility of RWE based study options and the evolving role of RWE based scientific evidence for internal and external (e.g. regulatory) needs.
Identify opportunities for synergies with other functions and drive alignment for improved efficiencies and impact.
Identify relevant data sources and develop partnerships to utilize high impact and quality data sources within their respective region and lead the identification of emerging data sources, platforms, and scientific methodologies in the industry.
Implement best practices and innovation in RWE and proactively identify opportunities and initiate process improvements for optimal quality, cost, speed, innovation, and efficiency.
Strong business acumen.
Oversight, Coordination, Execution & Delivery
Collaborate with the global, regional, and country medical leads, medical operations and program leads, regulatory, the chief digital office (CDO) RWE hub, advanced analytics, clinical development, and regulatory colleagues, as well as external partners including, vendors, institutions, and experts including the key thought leaders in the successful execution and delivery of RWE based studies.
Ensure compliance with the GBU governance processes such as the study review committee (SRC). Lead the development of study outlines and relevant materials for facilitating SRC reviews.
Ensure delivery of RWE based medical studies as per the agreed strategic plan within agreed on timelines and budget.
Embed appropriate scientific methodologies in observational research and statistical analyses at level that is aligned with the strategic requirements ranging from internal needs to high-quality regulatory grade evidence.
Solid Project and RWE management background
Solid experience of oversight on activities covering all study periods from start-up to study report
Solid organizational skills: results and quality oriented with the ability to multi-task, skill in establishing priorities and meeting deadlines.
Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
Ability to coordinate multiples interfaces: (e.g.) studies including several vendors
Ability to work autonomously, to efficiently and effectively provide status reports
Superb communication skills, multi-stakeholder experience, comprehensive understanding of business needs, and highly evolved capability in translating RWE based medical studies to diverse audiences.
Lead and/or coordinate the development of scientific publications and presentations at professional congresses that communicate the findings from RWE based medical studies.
Help develop strategic communication for internal and external stakeholders based on the real-world medical evidence generation strategy and findings.
Coordinate the development and implementation of tools derived from the RWE based studies.
Excellent written and verbal communication skills
Strong English skills (verbal and written if English is the second language) i.e., ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication
Alert on purpose, communicate on issues with proposed action plans.
Encourage collaboration and communication within and beyond the team, contribute to building a positive team spirit
Decision making & problem solving
Able to identify and anticipate study risks
Ability to synthetize, propose scenarios or action plans for decision making
Able to solve problems and make decisions when needed
Create buy-in/ support from stakeholders
Collaboration with partners
Ability to work cross functionally, ability to be flexible and adapt effectively to a variety of individuals
Experience in the management of vendors for outsourced activities
Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
Respond constructively to requests (i.e. either accept or challenge the request, why, when, who & what)
Share expertise with internal colleagues and study teams and through external communications, publications
Act for change
Ability to learn from experience and able to deal well with the changed circumstances in the environment (be open to new ideas and changes in order to be successful)
Readily adapt to new environment, jobs, technologies and processes
Ability to deal with frequent changes, delays or unexpected events
Strong expertise in one or more disease / Categories / Subcategories.
Represent the real-world medical evidence generation expertise on committees, task forces, and key stakeholder communication internally and externally within respective areas.
Expertise in state-of-the-art scientific methodologies in observational research and statistical analyses based on real-world data.
Familiarity with the regulatory guidelines, and the broader regulatory and payer environment as it relates to real-world medical evidence generation.
Develop and provide guidance to cross-functional teams to ensure that proper training on how to communicate real-world medical evidence.
Formal education and experience required
MD degree or a PhD in statistics, biostatistics, epidemiology, applied or quantitative sciences, or health economics.
Expertise in relevant scientific methodologies concerning real-world data analyses, including basic epidemiological methods, statistical modeling, and causal inference.
At least 10 years of experience in the healthcare industry in medical, epidemiology, health economics or related functions.
Strong expertise in one or more disease / Categories / Subcategories areas.
Excellent networking, influencing, and communication skills.
Demonstrated leadership in a global role in real-world medical evidence development
Clinical experience, skills and judgement are valued.
Experience in CHC is highly desirable
III – PRINCIPAL DUTIES AND RESPONSIBILITIES
Strategic RWE Expert for NA and Switch teams
Serves as methodological expert in FDA and other health authority interactions
Working with the Head of RWE, help to shape the adoption of RWE and policies related to RWE for both OTC and Rx-to-OTC switches
Work with cross-functional NA and Switch teams to provide guidance on RWE incorporation in other phases of evidence generation, i.e. clinical endpoints, recruitment, insight generation
Liaise with other Switch team members, i.e. commercial, in order to provide evidence around impact of Switch, post-Switch
Leads the Study Team on the Planning and Execution of RWE Studies for North America and Switch
Lead the Switch study teams for the all methodological and operational aspects of RWE studies.
Review and assess feasibility.
Review the RFP (request for proposal), review the proposal, participate in the selection of the vendor(s).
Liaise with each study team members to consider any input/requirements that could impact the operational conduct of the study.
Ensure study progress is aligned with the projections: drive and oversee study timelines, track budget, escalate risk to timelines and budget as needed.
Communicate changes and progress
Ensure proper documentation/availability
Develop following study documents as the author: Monitoring Plan, Study Communication Plan, Study Risk Management Plan, and any study operational material (e.g. Study newsletters, memo, etc.) as needed;
Liaise, review and approve documents with team /vendors: specifications of central services, scope of work, operational manual, etc. in conjunction with the study team.
Liaise, develop, and review study documents including SO, protocol, amendments, CRF completion guidelines, Centralized Monitoring Plan, recruitment and retention plan, committee charters and/or other operational documents as requested to provide operational input (including on-time and high quality).
Ensure study documentation is properly maintained and archived in the Trial Master File (TMF)
Organize study specific meetings
Organize and lead the core and extended study team meetings, including risk management discussions
with cross-functional team throughout the study lifecycle.
Organize and lead meetings/ TCs with local team representatives to oversee study progress
Ensure the training of the team
Contribute to data cleaning, data review meetings
Collect, synthesize and report study information
Maintain and provide information for monthly study reports (including enrollment curves, timelines, analysis of the study status and identification of potential risks)
Participate in selection and management of vendors, development/follow-up of the associated budget
Define needs, tasks and responsibilities of external vendors, participate in the BID, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study in collaboration with the buyers
Responsible for management of vendor relationship, and for vendor landscaping and identifying new potential vendors
Develop, manage and accountability of the study budget and timelines
Support the preparation and management of the overall study budgets (SPE).
Follow-up the budget during the study, making forecasts and following expenses/ accruals, identify
and evaluate complementary needs. Perform final budget reconciliation with vendors at study end.
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.