Sr. Director Global Health Economic and Outcomes Research (GHEOR)
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
The Director GHEOR will support the strategic goals of the GHEOR and Global Medical Affairs (GMA) driving patient access with optimal pricing and reimbursement for Madrigal Pharmaceutical’s medicines, with a focus on Rezdiffra.
This position directly impacts the ability to achieve business objectives on a global basis by providing strategic guidance and robust evidence development relevant to achieve optimal patient access by demonstrating the value of our medicines for liver health, with a primary focus on ex-US markets. The GHEOR Director will be responsible for developing and executing against the global integrated evidence plans and strategies including direct oversight of evidence generation activities and dissemination of technical deliverables. Key duties include the assessment of health technology assessment (HTA) strategies and deliverables on a global basis, working with global, in-region and in-country staff, agencies, opinion leaders, professional societies and trade associations, and contract research partners. Design and execution of economics models for HTA, real-world research studies, the creation, submission, and interactions relating to, successful HTA dossiers and outcomes.
This position will be part of Madrigal Pharmaceutical’s GHEOR team and will have the important role of managing health economics and outcomes research to generate data to support patient access, HTA success, and optimal pricing and reimbursement. This position will be working closely with the GMA, Clinical Development & Biostatistics, Access and Commercial, Regional and in-Country teams to foster a culture that promotes innovation, optimal population health and patient centricity.
Position Responsibilities:
- With HQ-based stakeholder, lead the development of the go-to-market evidence generation strategy to support the value of Rezdiffra, in close partnership with the cross-functional matrix team.
- Lead the coordination of input from local country/regional teams on evidence needs and ensure that the input is appropriately incorporated to develop and integrate the evidence strategy to support global market access needs at launch and through lifecycle.
- Lead the design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies) from concept through publication.
- Lead the timely development of launch and HTA deliverables including global value dossiers, systematic literature reviews, economic models, and innovative tools to successfully support reimbursement and access requirements in conjunction with the regions/countries.
- Provide strategic input into clinical trial designs (eg, patient populations, comparators, endpoints) and analysis to enable successful negotiations, reimbursement, and appropriate patient access with global payer and regulatory decision makers.
- Partner with internal stakeholders to ensure appropriate customer facing dissemination of HEOR materials per regulatory guidance and internal SOPs.
- Develop strategic partnerships and research collaborations with key external experts, healthcare policy makers, payers, and various academic and community oncology settings to support asset strategies.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Graduate degree required, e.g. MSc, MPH, PhD (health economics, epidemiology, health services research, or other research-focused public health field), PhD preferred
- 9+ years of experience with MSc/MPH degree required; 7+ years with PhD required in HEOR or relevant related fields (health economics, epidemiology, health services research, or other research-focused public health field)
- Direct experience with HTA organizations such as NICE, CADTH, PBAC, HAS, IQWiG/G-BA ICER and other HTA groups
- Demonstrated in depth understanding of fundamental health services research methods and tools, including health economic modeling, patient-reported outcomes, statistics, and real-world evidence studies including technical and methodological aspects of registries and observational study design, implementation, analysis and interpretation.
- Capable of independently managing complex non-interventional study projects on and international basis
- Knowledge and understanding of drug development process
- Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers
- Excellent oral and written English communication skills
- Demonstrated ability to assess anticipated value for projects/programs to ensure alignment to business priorities and prioritize accordingly
- An “execution mindset” focused on getting things done quickly and simply
- Strong project management abilities (contracting, budgeting, vendor management) essential. Demonstrated ability to manage multiple projects (multitask) involving complex processes, significant budget, competing deadlines and rapidly shifting priorities
- Ability to influence key members of medical, clinical, and commercial teams constructively and without conflict
- Skilled in functioning within a matrix organization, where managing through influence
- Organized and detail oriented with the ability to anticipate needs and to work proactively to prioritize & address/resolve
- Change oriented, comfortable responding to unexpected demands with tight timelines
- Knowledge and experience in hepatology/metabolics therapeutic areas with specific NASH experience
- Experience in supporting a global launch
- International mobility
- Incumbents eligible for titling at the Senior Director level will have led multiple major global launches, have extensive credentialing, networks, publications, HTA experience and will have developed and led innovative approaches to securing HTA success in Big-4 EU markets plus UK.
- Ability to travel internationally
- Ability to work in all global time zones
- Position can be based in US (HQ offices) but prefer in-theater base in Europe (Zug, Switzerland).
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic 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 the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
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