Director, RWE, CMH

Job summary

Drive the Real-World Evidence strategy and execution within Medical Affairs to inform clinical practice and regulatory decisions. Lead the design and oversight of observational studies and registries while collaborating cross-functionally to address critical data gaps.

Job details

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Summary 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. At Lilly Canada, we have multiple levels for this position based on the candidate’s experience, background, and qualifications. The expected compensation is: Senior Advisor: $129,750 – $190,300 Director: $142,500 - $209,000 This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program. This posting is for an existing vacancy. Key Responsibilities Evidence Strategy & Leadership 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. Study Design & Execution 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. Cross-Functional & External Collaboration 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. Communication & Dissemination In collaboration with Sr. Medical Director/Director/Medical Advisor 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. Team & Capability Development 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. Qualifications 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $129,750 - $209,000 Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

What you’ll do

Drive the Real-World Evidence strategy and execution within Medical Affairs to inform clinical practice and regulatory decisions. Lead the design and oversight of observational studies and registries while collaborating cross-functionally to address critical data gaps.

Requirements

Requires an advanced degree in epidemiology, health economics, biostatistics, or medicine with 8+ years of pharmaceutical or academic RWE leadership experience. Must demonstrate expertise in study design, RWD assets, and a track record of peer-reviewed publications.

Benefits

• Lilly Bonus Program
• Pension Plan
• Vacation Benefits
• Healthcare Benefits
• Flexible Benefits
• Life Insurance
• Death Benefits
• Time Off
• Leave Of Absence Benefits
• Employee Assistance Program
• Fitness Benefits
• Employee Clubs And Activities

Listed skills

• caring · Preferred
• Collaboration · Preferred
• Leadership · Preferred
• Health · Preferred
• Compliance · Preferred
• Execution · Preferred
• Communication · Preferred
• Development · Preferred
• Time · Preferred
• Communication Skills · Preferred
• Google Cloud · Preferred
• Flexible · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Real-World Evidence Strategy
• Observational Study Design
• Epidemiology
• Health Economics
• Outcomes Research
• Biostatistics
• Real-World Data Analysis
• Vendor Management
• Cross-functional Leadership
• Scientific Communication
• GCP Compliance
• GPP Compliance
• Payer/HTA Requirements
• Project Portfolio Management
• KOL Engagement
• Medical Affairs

Job areas

• Science & Research
• Healthcare
• Data & Analytics
• Management & Leadership

More jobs from Lilly