Director Real World Evidence Scientist (Oncology)

About the role

The Director, Real World Evidence Scientist is a highly experienced scientific expert who develops and owns the RWE strategy at the program(s) level, leads PRWE and CMS cross-functional initiatives, and interfaces directly with Global Program Teams (GPTs) and sub-teams.

Responsibilities

• Develop and own the RWE strategy at the program(s) level; interface directly with Global Program Teams (GPTs) and the subteams to integrate RWE into clinical development and regulatory strategies.
• Lead PRWE and CMS cross-functional initiatives
• Ensure planning and management of outsourced deliverables are effectively performed to the highest quality and in a timely manner.
• Ensure objective results interpretation and adequate internal communication in support of informative decision making at GPT, PST, and Senior Management level.
• Lead and execute the RWE strategy for assigned product(s) without supervision.
• Provide leadership in the development of RWE strategy in Integrated Evidence Plans (IEPs) in close collaboration with cross-functional teams; ensure RWE generation needs are included in the IEP and secure budget for strategy execution.
• Collaborate closely with development team functions (GPS, GRA, GMU, GVD, GCD) and commercial teams (Market Access, Marketing, GVAP) as well as within PRWE.
• For one complex/high-priority product or group of products: adequately and timely design, plan, initiate, monitor, and finalize NIS (including protocol development and study report writing); peer review key documents (protocol, study report, briefing books for Health Authorities).
• Ensure the identification and selection of fit-for-purpose RWD sources for given research questions; contribute to the RWD strategy of the assigned therapeutic area.
• Solves complex or novel problems by analyzing research findings. Interprets critical internal or external business issues and develops innovative solutions to help sustain competitive advantage.
• Represent PRWE in cross-functional governance bodies; direct the RWE contribution for publications.
• Represent Company in external interactions requiring RWE expertise; represent PRWE at international conferences and consortia, contribute to peer-reviewed publications, conference presentations and scientific communications.
• Research and implement state-of-the-art RWE methodology; develop RWE standards focusing on efficient study designs to support sound R&D decision making.
• Lead process improvement to gain efficiency in current SOPs/WIs, and develop new ones as needed; promote lean concepts; encourage and foster collaboration at all levels within PRWE.
• Ensure methodological intelligence on appropriate regulations, guidance documents, and methodological developments; provide sound and up-to-date recommendations to NIS conduct.
• Handle interactions with Health Authorities and manage difficult issues with limited supervision; represent the company during approval processes including defense of RWE aspects with regulatory agencies.
• Provide high quality input to critical review assessments, expert statements, publications, and study proposals from internal and external sources.
• Develop new processes and SOPs relevant for PRWE at Company and customize existing ones according to lean concepts.
• Manage budget associated with program-level RWE projects; maintain overview of budget spend by functional and program budget.
• Act as scientific mentor for less senior scientists within the function.

Qualifications

• Master's or PhD in Epidemiology, Public Health, Health Economics and Outcomes Research, or Biostatistics.
• 8-10 years of RWE experience in CRO, or pharmaceutical/biotechnology industry settings.
• Demonstrated strong experience in studies based on secondary data use (claims, EMR, registries) across different healthcare environments (Europe, US, Asia).
• Experience in studies based on primary data collection.
• Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.

Preferred Qualifications

• Strong methodological skills; medical/pharmacological/pharmacovigilance knowledge.
• Experience in project management as a global RWE leader, preferably in multi-cultural environments.
• Strong expertise in drug development, including interfaces and interdependencies of clinical development with other functions.
• Experience in global regulatory and/or payer submissions and interactions.
• Experience in at least one key therapeutic area (Oncology, Neurology & Immunology).
• Excellent understanding of the regulatory environment and standards.
• Track record of thought leadership (publications, conference presentations, advisory roles).
• Experience with AI/ML applications in RWE, including NLP.
• Experience with patient-reported outcomes (PROs) and health technology assessment (HTA).
• Experience in budget oversight and vendor management in global organizations.
• Knowledge of health equity and DEI principles in evidence generation.
• Involvement in industry working groups, regulatory advisory committees, or professional society leadership.