Director, RWE, CMH

Eli Lilly and Company • Toronto, ON

4d • Hybrid

About The Position

The RWE Director is responsible for driving the Real-World Evidence strategy and execution within Medical Affairs in collaboration with the therapeutic area. This role will ensure that robust, high-quality evidence is generated and communicated to inform clinical practice, regulatory/payer decisions, and healthcare policy, while addressing critical data gaps across the product lifecycle. The RWE Lead partners cross-functionally with Medical, Clinical Development, HEOR, Market Access, and external stakeholders to position the company as a scientific leader and trusted partner in improving patient outcomes. This is a hybrid role – onsite presence at our Toronto office will be 10 days or more per month (or at least 50% of the time), determined in collaboration with your manager and based on business needs.

Requirements

• Advanced degree in epidemiology, health economics, outcomes research, biostatistics, medicine, or related discipline (PhD, MD, PharmD, or MPH with strong RWE experience).
• 8+ years’ experience in pharmaceutical/biotech industry, CRO, or academia with direct RWE/observational research leadership.
• Demonstrated expertise in study design, epidemiologic/statistical methods, and working with RWD assets.
• Strong understanding of payer/HTA requirements, regulatory frameworks, and GPP/GCP compliance.
• Proven track record of peer-reviewed publications, congress presentations, and cross-functional leadership.
• Excellent communication skills; ability to influence internal and external stakeholders at senior levels.
• Experience managing vendors, RWE budgets, and complex project portfolios.

Responsibilities

• Collaborate and align with Sr. Medical Director/Director/Medical Advisor to develop the integrated evidence generation strategy for assigned therapeutic area(s), aligned with global/regional medical plans and corporate priorities.
• Prioritize and address evidence gaps related to disease burden, treatment patterns, patient outcomes, safety, and comparative effectiveness.
• Ensure evidence plans meet the needs of regulators, payers/HTA, healthcare professionals, and patients.
• Lead the design development, execution, and oversight of observational studies, registries, pragmatic trials, external control arms, database studies, and patient-reported outcome research.
• Manage vendor/CRO partnerships for study execution, ensuring quality, compliance, and timely delivery.
• Oversee due diligence and utilization of real-world data (RWD) assets including EMR, claims, registries, and digital health data.
• Partner closely with HEOR, Market Access, Regulatory, Clinical Development, Pharmacovigilance, and Commercial Insights to ensure evidence addresses cross-functional needs.
• Serve as the Medical Affairs RWE point of contact for internal stakeholders, training teams on RWE interpretation and application.
• Support Sr. Medical Director/Director/Medical Advisor in engagements and interactions with KOLs, academic collaborators, patient registries, and external data consortia.
• Drive dissemination of RWE through publications, congress presentations, dossiers, and educational activities per overall therapeutic area congress strategy.
• Ensure scientific integrity, compliance (GPP, GCP, SOPs), and transparency in all outputs.
• Provide RWE insights to inform medical education, payer submissions, label expansion, and health policy discussions.
• Provide mentorship to junior RWE scientists and medical team members.
• Champion innovation in data science, analytics platforms, and digital RWE solutions.
• Contribute to enterprise-wide RWE governance, standards, and capability building.

Benefits

• company bonus
• pension plan
• vacation benefits
• healthcare benefits
• flexible benefits
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

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