Director, GHER TMTT Real World Evidence

Edwards Lifesciences • Irvine, CA

80d • $170,000 - $241,000 • Hybrid

About The Position

This is a compelling opportunity to join the Global Health Economics & Reimbursement (GHER) team at Edwards Lifesciences, supporting patient access to innovative transcatheter mitral and tricuspid valve technologies (TMTT). As Director of Real-World Evidence (RWE), you will lead the strategic planning, execution, and oversight of real-world evidence generation using real-world data (RWD) to identify patient unmet needs, overcome market access barriers, and drive impactful evidence for clinical, regulatory, and commercial success. This role also includes direct people leadership responsibilities, with a strong emphasis on talent development, team building, and performance management. This hybrid position is based in Irvine, CA, requiring regular in-office presence, and reports directly to the VP of TMTT GHER.

Requirements

• Advanced degree (PhD, MD, PharmD, MPH, MSc, or equivalent preferred) in a relevant scientific, medical, or analytic field.
• Minimum of 8 years of analytic experience in statistics, data science, outcomes research, or related discipline.
• Demonstrated success developing and executing evidence generation strategies using RWD (e.g., claims, EMR, administrative data, adaptive clinical trial designs).
• Proven track record in leading teams and managing multiple RWE projects concurrently-both internally and with consultants-within the medical device, pharmaceutical, or healthcare industry.
• Proficiency in statistical programming (SQL, R, or Python) and advanced analytic methods (machine learning, predictive analysis) highly desirable.
• Experience collaborating with physicians on clinical research and co-authoring papers published in top-tier, peer-reviewed journals.
• Expertise in study design, endpoint operationalization, and data visualization using reporting tools (Tableau, Power BI, or similar).
• Strong business acumen and ability to translate data-driven insights into actionable strategies.
• Outstanding organizational, verbal, and written communication skills, with the ability to create technical and business reports, internal presentations, and publication-ready manuscripts.
• Ability to work effectively in a hybrid environment with regular days required in the Irvine office.
• Sound knowledge of applied statistics, regulatory and payer landscapes, and evidence requirements for medical devices.
• Experience engaging with external stakeholders to support evidence-based market access, portfolio planning, and commercialization objectives.

Responsibilities

• Provide leadership, vision, and direction for the RWE team, fostering a collaborative, high-performance culture.
• Oversee the planning, design, execution, and delivery of multiple, concurrent RWE projects: including studies conducted internally and with external consultants-ensuring scientific rigor and business alignment.
• Serve as a business partner and consultant, collaborating cross-functionally with colleagues across Edwards Lifesciences to meet organizational objectives.
• Develop and implement evidence generation strategies using RWD to articulate value, address unmet needs, and support portfolio planning, commercialization, and patient access.
• Demonstrated success in building and scaling high-performing teams within Real-World Evidence or related functions.
• Lead and mentor multidisciplinary teams in developing study designs, endpoint operationalization, and analytic plans for assigned studies.
• Direct the development and execution of data management plans across various relational databases, with proficiency in data cleaning, manipulation, and programming (SQL, R, or Python).
• Guide and collaborate on complex statistical analyses, including longitudinal data analysis, GLM, survival analysis, and propensity score matching.
• Collaborate with internal and external data management and statistical programming teams to generate research datasets and deliver insights.
• Engage and partner with physicians and clinical experts to develop high-quality clinical papers, abstracts, and presentations, resulting in publications in top-tier, peer-reviewed journals.
• Work collaboratively with the TMTT GHER US Coverage & Payment team, and support efforts to expand patient access to TMTT therapies by generating key evidence to support private and public payer coverage decisions.
• Collaborate with internal teams, particularly the TMTT GHER Service Line Value team, to support the development of customer-facing resources and programs that address the commercial evidence needs.
• Translate analytical findings into strategic recommendations that directly inform business decisions, market access strategies, and value propositions.
• Develop compelling narratives and visualizations that connect evidence generation to business objectives, enabling alignment across product development, payer engagement, and policy planning.
• Partner with external experts to augment internal capabilities, streamline study execution, and accelerate delivery of high-quality real-world insights.
• Serve as a strategic thought partner by contextualizing outcomes within broader market dynamics and organizational goals.
• Drive the creation of customized reports and data visualizations using tools such as Tableau or Power BI to translate research findings for diverse stakeholders.
• Build and maintain trusted business relationships with external stakeholders, including payers, hospitals, physicians, trade associations, and professional organizations, to develop mutually beneficial evidence strategies.
• Stay current with advances in RWE methodologies, applied statistics, advanced analytics, and machine learning through literature review, workshops, and professional meetings.
• Ensure all projects comply with ethical standards, regulatory requirements, and internal quality guidelines.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees