Senior Physician Scientist - RWE/Epidemiology
- Lead the clinical design of real-world evidence studies, including retrospective cohort studies, case-control studies, database studies, patient registries, and longitudinal observational cohorts.
- Ensure sufficient patients to support the objectives of all NIS studies.
- Serve as Medical Lead on non-interventional studies, ensuring compliance with UK regulations, ICH-GCP (where applicable) and GDPR.
- Oversee medical components of AI-assisted studies, AI-assisted data lake searches, model validation, algorithmic bias review, and clinical input into machine learning outputs.
- Be the main liaison to the Principal Investigator; in collaboration with PI make decisions to include/reject participants based on protocols, clinical practice, unit guidelines.
- Collaborate in strategic planning and design of screening activities with other departments to achieve study timelines - e.g. Patient Engagement Team and Recruitment
- Collaborate with the data science team to define clinically meaningful variables for analysis within data lakes, EHRs, claims databases, and patient registries.
- Ensure clinical relevance and regulatory alignment of RWD being used to develop AI models or predictive analytics tools.
- Integration of external structured and unstructured datasets to provide externally validated RWE
- Provide clinical interpretation of epidemiological data outputs, including incidence, prevalence, risk factor modelling, and survival analyses.
- Guide the development of disease definitions, cohort selection algorithms, and clinical phenotypes for use in large datasets.
- Review and approve data handling plans (DHPs) and data analysis plans (SAPs) from a clinical perspective to ensure scientific rigor and relevance.
- Contribute to or review scientific documents such as: Study protocols, Statistical analysis plans (SAPs), SOM sections for GLSO, PIS/ICF sections
- Attend REC meetings and present study applications
- Support dissemination of findings through white papers, presentations, and peer-reviewed publications.
- Prepare presentations for prospective sponsors on study proposals e.g., bid defence
- Act as a key medical point of contact for clients, sponsors, and regulatory authorities, supporting bid defences, project kick-offs, and ongoing delivery.
- Provide strategic consultation to clients on leveraging RWE and AI for market access, pharmacovigilance, or value demonstration.
- Ensure studies meet MHRA, HRA, REC, and international standards for data integrity, ethics, and participant confidentiality.
- Participate in internal QA reviews, audits, and compliance checks.
- Lead from study set-up to end of trial
- Assist PI with PI oversight responsibilities through regular updates and direct reporting
- Collaborate with data, biostatistics, and operational teams to ensure study objectives are met on time and to a high standard.
- Ensure Non-Conformances relating to the study are dealt with effectively and completed
- Actively seek opportunities for innovation through science and process improvement to address business needs
- Participate in Quality improvement and Quality assurance activities
- A matrix leader for all study delivery team members
- Communicate updates through communication channels (e.g., Town Hall presentations, conferences, and other external events)
- Medical Degree (MBBS, MBChB, MD, or equivalent)
- Full GMC Registration
- Postgraduate Clinical Training
- Adult Life Support (ALS) certificate
- Postgraduate Qualification in Epidemiology, Public Health, or Clinical Research (Desirable)
- Training in Real-World Evidence (RWE) Methodologies (Desirable)
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