Associate Director Real World Evidence Scientist

About the role

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.

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.

Minimum Qualifications

• 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).

Preferred Qualifications

• 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.

Pay

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.