Head, Evidence Generation and Publications

**_ PURPOSE OF JOB/POSITION_**

**_ ACCOUNTABILITIES_**
- To formulate evidence generation strategy and provide consultative expertise primarily at peri-launch, launch and commercialization stages across the product lifecycle for Oncology and IBD.
- To lead the development and execution of plans to elucidate unmet clinical, economic and patient-centred needs and product value
- To engage with CROs to design, execute and communicate results of appropriate tactical activities supporting those plans
- To collaborate and align internally with other Takeda teams within a matrix organisation to ensure timely and effective delivery of evidence generation and publication plans.

To communicate findings from these evidence generation activities through high quality publications in peer-reviewed journals as well as scientific congress presentations.
- Work within a multidisciplinary, matrix organization to develop and execute successful evidence generation strategies for the Specialty portfolio (with a focus on RWE, outcomes and epidemiology studies)
- Lead 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
- Lead the strategy for the design, implementation and communication of results of real-world, health outcomes and epidemiology research studies that help achieve product-specific objectives.
- Provide consultative advice and collaborate and partner with medical affairs colleagues across EM to help refine their evidence generation plans.
- Have good knowledge of PRO and HRQoL instruments and interpretation of data collected through these tools to articulate value of therapy
- Provide oversight for the preparation of 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.

**_ FUNCTIONAL KNOWLEDGE, BUSINESS EXPERTISE, NATURE OF IMPACT, _**

**_COMMUNICATION SKILLS, INNOVATION_**
- Experience in outcomes and observational research and/or pharmaco-epidemiology in speciality care pharmaceuticals
- Demonstrated experience in leading, designing and conducting observational studies focusing on rare diseases, oncology, IBD is highly desirable
- 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.

**_ CAPABILITIES_**

**Critical technical, professional and personal capabilities**
- 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 five years practical experience in performing observational research, in any setting, including life-sciences company, research organization, academic institution or governmental agency
- Masters degree in a related discipline (as noted above), plus eight 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 drug development and commercialization environment and process is expected.
- Demonstrated experience in meta-analysis and a record of publishing in peer-reviewed journals 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 analys