Director, RWE, CMH

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.

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.

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.

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)
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