Associate Director OR Director – Evidence & Value Generation - United Kingdom
- This position functions within company’s Global Medical Affairs organisation and reports into the Head of Evidence Generation – Specialty GI.
- As a member of the Evidence and Value Generation team, the candidate will engage in research studies that identify clinical, economic, and patient-centric unmet needs in addition to value that company’s medicines provide in addressing these needs.
- To provide support and consultative expertise primarily at peri-launch, launch and commercialization stages across the product life cycle
- To contribute to the development and execution of plans to elucidate unmet clinical, economic and patient-centered needs and product value
- To design, execute and communicate results of appropriate tactical activities supporting those plans
- To collaborate and align internally with other company teams within a matrix organisation to meet product needs
- To communicate findings from these evidence generation activities to relevant internal and external audiences as effectively as possible.
- Work within a multidisciplinary, matrix organisation to develop and execute successful outcomes and epidemiology research strategies for the GI Specialty therapeutic area
- Design, implement and communicate results of real-world, health outcomes and epidemiology research studies that help achieve product-specific objectives.
- Represent the function on cross-functional teams related to product development and commercialisation.
- Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned
- Perform relevant research activities which may include, but are not limited to:
- Targeted or comprehensive systematic literature reviews
- Design, execution, and analysis of longitudinal prospective observational or randomized clinical trials evaluating clinical, patient-centered, and/or economic endpoints
- Longitudinal retrospective studies of existing databases
- Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence
- Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities
- Clinical-economic models and assessments exploring burden of illness and/or comparative effectiveness
- Have good knowledge of PRO and HRQoL instruments and interpretation of data collected through these tools to articulate value of therapy
- Prepare and/or review research protocols, statistical analysis plans (SAPs),and reports
- Prepare, review, and publish scientific reports reflecting ongoing or completed work
- Communicate findings to relevant internal and external audiences, which may include regulators, health care providers/practitioners, HTA authorities/payers, patients and others
- Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, and submission dossiers.
- Experience in outcomes and observational research and/or pharmacoepidemiology in specialty care pharmaceuticals
- Demonstrated experience in designing and conducting observational studies focusing on IBD or immune mediated disorders is highly desirable
- Combination of academic training and practical experience in outcomes research, epidemiology, pharmacoepidemiology, or real world evidence generation is required. This may consist of:
- Doctoral degree in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, public health, economics, statistics or decision sciences, plus practical experience
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus practical experience
- Masters degree in a related discipline (as noted above), plus extensive practical experience.
- Practical experience in performing observational research, in any setting, including life-sciences company, research organisation, academic institution or governmental agency, is required.
- Experience should include communication of study findings to internal and external audiences.
- Familiarity with the role and importance of real world evidence, epidemiology, observational, and outcomes research in the multi-disciplinary drug development and commercialization environment and process is expected.
- Demonstrated expertise in at least one research area (such as, but not limited to, retrospective or prospective observational studies, patient-reported outcomes/health-related quality of life assessment, clinical-economic modelling and analysis, literature synthesis/meta-analysis) is highly desirable.
- Knowledge of health economics is desirable.
- Demonstrated experience in conducting or interpreting statistical analysis.
- Experience in conducting research in different geographic regions is desirable.
- Ability to work collaboratively and effectively in a multicultural and cross-functional team environment is expected.
- Broad experience in collaborating with contract research organisations and research partners in managing multiple tasks and complex projects is very desirable.
- Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Record of high-quality, peer-reviewed publications is preferred.