Evidence Generation Lead, Gem

**OBJECTIVES**

A significant focus of the role will include capability building across the GEM region: demonstrating the value of generating (real-world) evidence (impact and utilisation), leading cross-functional evidence gap analysis and planning workshops (identification/prioritisation), and educating (and guiding) on approaches that can be utilised to address evidence gaps.

Key objectives are:

- To develop, maintain and track integrated evidence plans for assigned compound(s) in the GEM region.
- To support Head, Evidence Generation and Publications plan, initiate and execute on key initiatives for assigned compound(s) in the GEM region.
- To collaborate with key internal stakeholders in the region including Regional, Area and Local Therapeutic Area Medical Heads/Leads, and Pricing and Market Access/HEOR Leads to help formulate the evidence generation strategy and provide consultative expertise primarily at peri-launch, launch and commercialization stages across the product lifecycle for assigned compound(s).
- To lead initiatives and development of training materials with the aim of increasing Area/LOC capabilities in evidence generation.

**ACCOUNTABILITIES**:

- Work within a multidisciplinary, matrix organization to develop and execute successful evidence generation strategies for the Specialty portfolio (with a focus on RWE/outcomes studies).
- Lead relevant research activities, as required, which may include:

- 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
- Retrospective studies of existing databases
- Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence
- Post-hoc analyses of existing studies, including registrational trials
- 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
- Support the strategy for the design, implementation and communication of results of RWE/outcomes research studies that support compound-specific strategic imperatives and tactics.
- Advocate and lead evidence planning in the GEM region, with the Areas and LOCs.
- Provide consultative advice and collaborate and partner with Pricing & Market Access/HEOR and Medical Affairs colleagues, including Area/LOC Evidence Generation Leads across GEM, to help refine their evidence generation plans.
- Collate, develop and maintain an integrated evidence plan for the GEM region for assigned compound(s).
- Represent GEM on Global evidence sub-team meetings for assigned compound(s).
- Provide guidance/oversight to GEM Areas/LOCs in the preparation of research protocols, statistical analysis plans, study reports and publications, as required.
- Prepare relevant training materials and provide training to key stakeholders in specific disciplines related to (real-world) evidence generation.
- Prepare, review, and publish scientific reports reflecting ongoing (interim) or completed work (including post-hoc analyses of interventional and RWE studies).
- Communicate findings to relevant internal and external audiences, which may include regulators, health care providers/practitioners, reimbursement authorities/payers, patients and others via conference presentations, publications, and submission dossiers, etc.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Experience in outcomes and observational research and/or pharmaco-epidemiology in specialty care pharmaceuticals.
- Demonstrated experience in managing, designing and conducting observational studies.
- Disease-related experience in vaccines, oncology, gastrointestinal/inflammatory bowel disease, rare disease immune disorders is highly desirable.
- Combination of academic training and practical experience in outcomes research, epidemiology, pharmacoepidemiology, or RWE 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 3 years practical experience in performing observational research, in any setting, including life-sciences company, research organization, academic institution or governmental agency
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus 3 years practical experience in settings mentioned above
- Masters degree in a related discipline (as noted above), plus 5 years practical experience in settings mentioned above
- Familiarity with the role and importance of (real-world) evidence, epidemiology, observational, and outcomes research in the multi-disciplinary d