Job Description Summary
The Evidence Generation Lead drives the integrated Real‑World Evidence (RWE) strategy at country level, ensuring robust evidence packages that support access, reimbursement, value demonstration, and lifecycle excellence for Novartis brands and pipeline assets. The role partners cross‑functionally to identify evidence gaps, shape local RWE plans, and deliver high‑quality evidence generation and analytics solutions. By translating scientific and methodological rigor into actionable evidence, the RWE Lead contributes to sustainable patient access, informs healthcare decision‑making, and reinforces Novartis’ reputation for scientific excellence.
Job Description
Job Dimensions
Number of associates:
Single contributor role.
Financial responsibility:
Oversees study budgets and vendor contracts associated with local RWE activities. Contributes to efficient resource use within Medical Affairs evidence generation.
Decision making:
Makes scientific and methodological decisions related to local RWE plans, prioritization of evidence‑generation activities, selection of data and analytics solutions, and study design within established governance.
External/internal stakeholders Interface:
- Internal: Medical Affairs (TAs), Value & Access, HEOR, Regulatory, Clinical Research, Medical Evidence & Governance, Execution Excellence, Commercial TA, Global/International/Regional RWE, ERC.
- External: Academic institutions, external research organizations, data partners, vendors, scientific societies, HCPs/MEs.
Impact on the organization:
Strengthens evidence‑based decision‑making, supports access and reimbursement success, enhances value demonstration of Novartis brands, and accelerates lifecycle excellence through the systematic generation and integration of real‑world evidence.
Major Accountabilities
RWE Strategy & Planning
- Assess evidence gaps and develop local RWE generation plans for marketed brands and pipeline assets.
- Analyze the local RWE landscape with cross‑functional teams and Regional/Global RWE partners, anticipating data needs and access challenges within a 1‑ to 3‑year horizon.
- Align RWE plans with Early Value Access, New Products, and clinical trial prioritization strategies.
- Provide input to Global and Regional teams on data‑generation needs for pipeline assets.
Evidence Generation & Execution
- Recommend appropriate data and analytics solutions based on scientific and methodological requirements.
- Lead the tactical execution of the RWE plan, ensuring timely and high‑quality delivery of evidence‑generation activities.
- Collaborate with external stakeholders (academic institutions, data providers, CROs) to execute RWE projects in alignment with internal governance.
- Ensure strong project management, operational discipline, and adherence to internal processes in all RWE initiatives.
Scientific Communication & Publications
- Conduct routine literature reviews to monitor the competitive landscape and the evolving evidence base.
- Lead and coordinate publication activities for RWE outputs, ensuring high scientific standards and effective dissemination.
- Translate complex methodological and statistical content into clear, actionable insights for internal and external stakeholders.
Cross‑functional Partnerships & Access Support
- Partner with Value & Access, HEOR, and Medical TAs to develop evidence supporting reimbursement dossiers, formulary listings, and value updates.
- Network across the organization to identify collaboration opportunities and share best practices in RWE methodology and execution.
- Lead capability‑building for RWE understanding and execution at local level, in collaboration with Medical Evidence & Governance and Execution Excellence.
Compliance & Governance
- Uphold Novartis ethical standards, ensuring all RWE activities comply with national legislation, data‑privacy requirements, internal policies, and functional excellence standards.
- Maintain accurate documentation and reporting of RWE activities, supporting audit readiness and continuous process improvement.
Metrics
Input Indicators (what the RWE Lead prepares or brings into their work)
- Completion of all mandatory internal trainings required for the role.
Process Indicators (how the RWE Lead performs their work):
- Timely and compliant execution of RWE activities according to internal governance, data‑privacy, and methodological standards.
Output Indicators (what the RWE Lead directly delivers)
- Delivery of planned RWE evidence‑generation activities (e.g., analyses, studies, datasets, publications) according to the annual RWE plan.
Outcome Indicators (effects achieved through the RWE Lead’s outputs)
- Demonstrated integration of RWE insights into reimbursement dossiers, access strategies, or cross‑functional decision‑making processes.
Impact Indicators (contribution to Novartis, the healthcare system, and patients)
- Contribution of RWE outputs to sustained or improved patient access, reimbursement success, and contract renegotiation outcomes;
- Reinforced scientific reputation of Novartis through high‑quality publications and stakeholder engagement.
Ideal Background
Education:
- University degree in Science, Epidemiology, Biostatistics, Pharmacy, or related discipline with a solid technical background.
- Advanced degree (MSc, PhD) in Epidemiology, Biostatistics, Public Health, or related field desirable.
Languages:
Experiences:
- At least 3 years of experience in RWE, epidemiology, health outcomes, or related scientific roles in academia or industry.
- Deep understanding of RWE methodologies, including observational research, epidemiologic study design, statistical techniques, and outcomes assessment.
- Knowledge of operational and scientific aspects of clinical development, including post‑marketing and RWE activities.
- Experience supporting reimbursement, access, or value demonstration processes is a plus.
- Experience interacting with regional/global RWE or HEOR functions is desirable.
Functional Capabilities:
- Strong analytical skills and ability to interpret and communicate complex data.
- Expertise in clinical investigation methodology, epidemiology, and biostatistics.
- Solid understanding of drug development and market access processes.
- Ability to design and oversee local evidence generation (RWE, observational studies, registry programs).
- Strong project management capability and ability to work cross‑functionally.
- Business mindset and Healthcare Systems thinking, anticipating data needs and access challenges.
- Solid understanding of compliance, data‑privacy, regulatory requirements, and governance processes.
Interpersonal Capabilities & Mindset:
- Scientific curiosity and growth mindset.
- Ability to influence without authority and engage stakeholders across functions.
- Acts with credibility and clarity of purpose to build and maintain effective and collaborative relationships.
- Collaborative, cross‑functional orientation.
- Clear, impactful communication; ability to simplify complex scientific and methodological concepts.
- Adaptable, resilient, and comfortable navigating ambiguity.
- High integrity, ethical judgment, and a patient‑centric mindset guiding all interactions.
- Rigorous process stewardship, following internal procedures precisely, maintaining high documentation standards and proactively addressing gaps.
Skills Desired
Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)