Director - Real World Evidence (RWE) - Saudi

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.

The demand for high quality health economic and outcomes research (HEOR) and real-world evidence (RWE) to support drug development, health technology assessment/access decisions, product differentiation, and clinical decision making continues to increase. Lilly Kingdom of Saudi Arabia (KSA) is looking for a talented, energetic, creative, diverse, influential, and collaborative team member to join the Medical Affairs function and Team Lilly to propel local KSA and META-hub level evidence generation activities.

The RWE Director role for KSA is a strategic leadership role responsible for the design, execution, and application of RWE strategies within the KSA healthcare ecosystem. The role will focus on leveraging real-world data to support regulatory, reimbursement, and clinical decisions, ensuring the value of products is demonstrated effectively in the local context. The director will need to work with cross-functional, multidisciplinary teams to facilitate and support Lilly KSA – META and beyond with the design, implementation, application and integration of RWE, Implementation Science and other study types and evidence generation in general. The director will also play a key role in building and managing RWE partnerships with local stakeholders, ensuring high-quality evidence generation, and aligning RWE strategies with both the objectives of Lilly KSA and those of the evolving healthcare landscape in KSA. In this exciting role you will provide both technical and project administrative expertise to propel evidence-based medicine and decision making.

Path/Level: R6-R7 (Depending on applicant profile)

Responsibilities:

1. Provides technical and project administrative ownership to help enable on-time and on-budget delivery of key tasks during RWE project design, implementation and post study completion activities.
2. RWE Strategy-Dissemination and Leadership:
   1. Develops and implement the overall RWE strategy for KSA, ensuring alignment with corporate regional objectives.
   2. Leads and oversees the generation of local RWE through observational studies, database analyses, patient registries, and other relevant methodologies.
   3. Develop evidence dossiers, publications, and presentations to communicate the findings of RWE studies to local healthcare authorities, payers, and other key stakeholders.
   4. Ensure that RWE insights are incorporated into value propositions, health technology assessments (HTAs), and reimbursement submissions.
   5. Ensures RWE efforts are scientifically rigorous, adhere to ethical standards, and comply with local regulations and guidelines.
   6. Work closely with the regional and global RWE teams to align local strategies with global initiatives and insights.
3. Project Management:
   1. Drives the implementation, application, and integration of standard project management processes and tools including but not limited to the development, monitor, and control of timelines and budgets.
   2. Facilitates delivery of project milestones with quality on time, on budget, and within scope.
   3. Ensures that cost, timelines, scope and risk management processes are in place to monitor and control performance and appropriateness of the maintained projects.
   4. Holds supportive functions accountable for achievement of key project deliverables in alignment with the agreed project plan and in compliance with corporate quality standards.
   5. Facilitates Vendor Requests for Proposals (RFPs), contracting, internal documentation and archiving, Risk, Privacy and Quality assessments, PO set-up, invoice processing, record management in internal systems.
   6. Takes on research management tasks tracking the progress and volume of the studies across key milestones and presenting regular updates on the status of all studies to the relevant internal/external stakeholders
   7. Ensures good documentation practices. Uploads study protocols, reports and other study documents in the appropriate system for review, approval and storage.
   8. Works x-functionally to align resources based upon team prioritization decisions.
   9. Influences decision-making by translating results into actionable options/scenarios.
   10. Contributes to RWE process improvements.
4. Collaboration and Internal/External Stakeholder Engagement:
   1. Builds and maintains relationships with local regulatory bodies, policymakers, and academic institutions to advocate for the use of RWE in decision-making processes.
   2. Builds data-driven partnerships with the healthcare system leading to joint evidence generation activities and population health model approaches.
   3. Collaborates with cross-functional teams (e.g., Medical Affairs, Market Access, Commercial, and Clinical Development) to ensure RWE strategies are integrated into broader market access and commercialization plans.
5. Internal Team Development:
   1. Provide training and guidance on RWE methodologies, latest trends and best practices to medical and cross-functional teams, as needed.
   2. Conduct regular integrated evidence planning activities and workshops within each therapy area while ensuring alignment of early evidence planning with the agreed product strategy as well as timely and impactful identified gaps closing and communication plan.
6. Professional Development:
   1. Keep up to date on trainings for professional development.
   2. Ensure company internal technical and general training are completed in line with relevant guidance.
7. Basic Requirements:
   1. Bachelor's Degree preferably in a scientific or health-related field (life sciences, public health, epidemiology, biostatistics, or a related field).
   2. An MD or PhD is preferred (optional).
   3. At least 5 years' experience in clinical trials, real world evidence and/or knowledge in RWE and health outcomes research in Saudi Arabia.
   4. Additional certifications or training in RWE methodologies or clinical research, are desirable.
8. Knowledge and Experience:
   1. Knowledge, experience and understanding of the use of healthcare data used in RWE, outcomes research, implementation science etc.
   2. Demonstrated knowledge and experience with project management tools and process.
   3. Experience in medical, scientific or technical writing fields.
   4. Strong comprehension and communication skills including the ability to translate and disseminate complex scientific information in a clear and concise manner.
   5. Knowledge and experience of local health care systems and databases.
   6. Understanding of and experience with clinical research environment incl. vendor management and running outsourced evidence generation projects / studies.
9. Skills:
   1. Demonstrable strong communication and interpersonal skills and the ability to work successfully in a cross-functional environment and to engage effectively with senior executives, regulatory bodies, and external stakeholders.
   2. Fluency in Arabic and English languages.
   3. Demonstrated ability to influence individuals.
   4. Demonstrated project management skills.
   5. Strong analytical and problem-solving skills, with the ability to interpret complex data and present actionable insights.
10. Other role requirements:
    1. Saudi Nationals preferred
    2. The ability to travel domestically and internationally, with travel is estimated to be up to 10%.
    3. Must be legally allowed to work in KSA

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