Director Real World Evidence Scientist (Oncology)

Merck•Billerica, MA

About The Position

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. This role provides deep scientific leadership for the RWE strategy for one complex/high-priority product or group of products — leading and executing end-to-end RWE activities, providing expert oversight of studies, and representing our organization externally — without formal line management responsibilities.

Requirements

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.

Nice To Haves

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

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.