The Director, Outcomes Research (OR), must be highly innovative, proactive and collaborative with mature team-working behaviors. As a member of the ORE department, an outcomes researcher at Shire must have a broad view of the role of outcomes research in product support, contributing across target identification, through drug development, value demonstration, market access, and post-approval effectiveness. Outcomes researcher interacts with a wide variety of internal and external stakeholders to ensure appropriate communication of results including interacting with regulatory authorities is expected.
- Lead the development, implementation and communication of OR studies and economic model frameworks agreed upon by the project teams in order to maximize opportunities for Shire products
- Lead in the development of patient reported outcomes and other clinical outcome assessment strategies and projects to support the value of Shire products
- Lead the development of ORE evidence generation plans to supportinternal and external evidentiary needs
- As the product lead, ensure that OR and health economics projects have received input from cross functional stakeholders
- Identify, evaluate, retain and oversee a global network of consultants and contract organizations to execute the OR and health economics evidence generation deliverables (e.g. any study design evaluating the outcomes of healthcare interventions– observational cohort studies, cross-sectional studies, systematic reviews, meta-analyses, etc.)
- Maintain awareness of new methods, tools and data sources to ensure study designs are technically sound and appropriate and for market access, commercialization and/or publication needs
Global Product responsibilities
- Contribute to global product strategy and target product profiles in support of drug development and market access plans for global markets
- Lead in the design and effective management of projects and studies
- Ensure effective, efficient and timely execution of evidence generation to support product
- Contribute and collaborate during the product strategy development and project execution process and contribute to a robust dissemination plan for use of OR data
- Produce OR designs across the product life cycle that demonstrate product value for target audiences (payers, physicians, or patients).
The Director is responsible for
- Engaging the team members and effectively executing and communicating the strategy to internal teams and external vendors
- Effectively triaging concerns and proactively engaging the appropriate ORE team members to inform and to be advised
- Identifying strategic or implementation problems early and identifying and engaging appropriate resources (e.g. TA/BU leads or line management) that can help solve the problem
- Ensure that all final deliverables are of high scientific quality and are presented in a way that supports the agreed upon product strategy
- Identify conceptual, strategic or methodological issues (especially in non OR projects) and seek expert advice
- In conjunction with the cross-functional partners assist, as needed, in the development of the product value proposition, contribute OR evidence to the Global Value Dossier (GVD), and be an active contributor to completing the evidence supporting the value proposition
- Maintain awareness of global ORE requirements, regulatory legislation, payer and HTA trends and requirements
Education and Experience Requirements
- Master’s degree in ORE related field (Public Health, Economics, Epidemiology, Statistics, Health Services Research (or similar)) with 10-14years experience in life science related field is preferred, doctorate degree (PhD, MS, MPH) in ORE related field or PharmD/MD with Master’s degree in ORE related field with at least 9years experience in life science related field is preferred.
- Experience in OR research and health economic modeling methodologies (Retrospective observational cohort, cross-sectional studies, registries, cost-effectiveness and budgetary impact models, etc.) to support product development and reimbursement efforts and experience interfacing with external scientific bodies & preference for experience with interactions with reimbursement agencies in US and/or Europe. An educational background and/or experience in clinical outcome assessments (eg., patient-reported outcomes) and psychometric methods is highly valuable.
Req ID: R0017725