Associate Director Real World Evidence Scientist

Merck • Billerica, MA

3d

About The Position

The Associate Director, Real World Evidence, is an experienced functional lead and subject matter expert who proactively contributes to the development and implementation of the Real-World Evidence and Real-World Data (RWE/RWD) strategy for a therapeutic area or set of compounds, with a primary focus on supporting regulatory objectives. Operating with a high degree of independence, this role leads non-interventional studies end to end, provides methodological expertise in key internal strategic forums, and interfaces with Global Program Teams and their sub-teams.

Requirements

• Doctoral and/or master’s degree (e.g., PhD, MSc) in Epidemiology, Public Health or related field.
• 5+ years experience in health and life sciences (MD, pharmacist epidemiology, public health), or quantitative data sciences, biostatistics.
• 5+ years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting.
• Demonstrated experience in studies based on secondary data use (claims, EMR, registries) across different types and healthcare environments (Europe, US, Asia).
• Comprehensive expertise in drug development, including interfaces and interdependencies of clinical development with other functions.
• Experience in global regulatory and/or payer submissions and interactions.
• Experience with the regulatory environment and standards (ISPE GPP, GVP, ENCePP).

Nice To Haves

• Experience in studies based on primary data collection.
• Experience in at least one key therapeutic area (Oncology, Neurology, Immunology).
• Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.
• Experience with AI/ML applications in RWE, including NLP.
• Track record of thought leadership (publications, conference presentations).
• Experience in budget management and vendor oversight.
• Knowledge of health equity and DEI principles in evidence generation.
• Experience with patient-reported outcomes (PROs) and HTA.
• Excellent oral and written communication skills and demonstrated ability to engage and communicate scientific evidence to peers and at scientific meetings.
• Collaborative, proactive working style, with ability to work independently.

Responsibilities

• Serve as the functional product lead and subject matter expert for assigned studies, conducting needs assessments with relevant stakeholders.
• Provide senior-level strategic input into drug development plans and Product Integrated Evidence Plans.
• Execute the RWE strategy for assigned products and lead studies with minimal supervision.
• Represent and defend projects at internal boards, governance committees, and senior management meetings.
• Lead the identification and selection of appropriate real-world data sources, and drive the development of the therapeutic area's real-world data strategy.
• Collaborate closely with development, regulatory, medical, commercial, market access, and Patient Real-World Evidence (PRWE) teams.
• Lead Non-Interventional Studies from end to end, including study design, planning, protocol development, monitoring, analysis, study reporting, and dissemination of results.
• Support interactions with health authorities and develop responses to requests from regulatory agencies.
• Foster cross-functional collaboration and maintain and expand external collaborations with other quantitative scientists.

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Director