The Director of Health Economics & Outcomes Research (HEOR) is responsible for the development of specific HEOR projects and strategies including their tactical execution. The individual will ensure the successful implementation of assigned programs/projects through appropriate research design, project management, analysis, interpretation and dissemination of HEOR evidence to appropriate stakeholders.

The Director HEOR, in collaboration with department leadership, is responsible to ensure that health economics, outcomes and quality data are produced to ensure the scientific medical understanding of the potential value and real-world impact of Resmetirom across payers, healthcare providers and patients.

Core Function:

Build and lead the HEOR function including development of global HEOR strategy, evidence generation, and provide subject matter expertise that supports the clinical, economic, and patient centered value propositions, as well as reimbursement requirements for resmetirom in the US and ex-US

Design and execute projects included in the strategic plan, such as on the burden of illness, real-world clinical and economic outcomes of disease using clinical registries, retrospective database analyses, and meta-analyses

Prepare, edit, and review study protocols including statistical analysis plans (SAPs), for the development of database analysis, cost, and disease models

Lead the development of pre, peri-, and post-launch, deliverables including AMCP dossiers, global value dossiers (GVDs), economic models, systematic literature reviews, and other tools to support global reimbursement and access requirements

Lead and support early scientific advice opportunities with key global health technology agencies and incorporate the relevant advice into the global HEOR plan and market access plans

Lead the development of payer facing resources such as budget impact models, and payer presentation materials

Lead HEOR publication planning to communicate HEOR research

Collaborate with HCPs, payers and relevant organizations to identify evidence needs and to evolve economic tools and models for such audiences

Manage vendors (e.g., data analysis and model development resources) for supporting the launch and sustainment of HEOR projects

 

Cross Functional Support/Collaboration:

Ensure all HEOR tactics are aligned cross-functionally with overall product/portfolio strategies business strategies and regulatory guidelines

Advise and support medical affairs and clinical project teams in the design of clinical trials/studies, with health economic and clinical outcomes assessment. (COA) endpoints in alignment with market access and regulatory authority requirements, working with department experts as needed

Serve as the interface to support pharmacoeconomic and real-world evidence needs across Madrigal medical affairs and other functions including market access, payer marketing, and clinical development

Present health outcomes projects and information to groups internal and external to the company, including regulatory authorities, key opinion leaders, physicians, and medical and outcomes research conferences

Coordinate the delivery of HEOR publications or external facing payer materials with Madrigal Scientific Communications and Medical function leads

Support preparation of medical or payer advisory meetings to solicit feedback on Resmetirom and therapeutic area specific disease impacts

Assist Marketing/Market Access colleagues in developing patient and caregiver education and payer awareness materials on disease, unmet need, and epidemiology which is in alignment with regulatory guidance

Willingness to travel to conferences, various corporate locations, and stakeholder meetings, including overnight trips

Some international travel may be required

Requires approximately 30% travel

Responsibilities:

PhD, PharmD, or Masters in Health Economics, Outcomes Research, Health Services

 

Research, Public Health or related discipline with at least 8 years' relevant experience

Experience in outcomes research including dossier submissions for reimbursement, COA research including questionnaire design, evaluation, and/or analysis, and in design/development of pharmacoeconomic models

Knowledge of the Healthcare industry including the pharmaceutical industry [R&D, clinical research and commercialization (marketing & sales)] as well as health technology assessment bodies, managed care marketplace, hospital systems and integrated systems of care

Knowledge of epidemiology, economics, psychometrics and medical writing

Strong expertise in non-interventional study designs and methodological considerations in the statistical analyses of such research designs

Strong understanding of the application and limitations of administrative claims data, electronic medical records data, hospital inpatient data, and patient or physician reported survey data

Ability to independently develop research hypotheses, study protocols, and statistical analysis plans

Highly motivated self-starter who is able to work independently, deal with complex issues and relate to multiple internal and external stakeholders

Excellent interpersonal skills and the ability to understand and respond to multiple internal and external customer requests and manage conflict constructively with minimal supervisory support required

Working knowledge of customer/payer tool development and value dossiers

Experience working with and overseeing external contractors and vendors

Superior presentation skills that drive action and strategy required

Excellent communication skills, problem solving abilities, and interpersonal skills required

Statistical programming and project management experience required

Ability to manage complex projects that could require multiple external vendors

Madrigal is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status, or any other characteristics protected by applicable federal, state or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from using resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement has been established between Madrigal and the agency.

Proof of full vaccination against COVID-19 prior to start date is required.