Madrigalpharma
Director, Global Health Economic and Outcomes Research (GHEOR)
Madrigalpharma, Conshohocken, Pennsylvania, United States,
About Madrigal: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, Global Medical Affairs (GMA), and Global Access 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.
Position Responsibilities:With HQ-based stakeholders, 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 design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies, economic models) 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.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.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 Rezdiffra 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.
Qualifications and Skills Required: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.7+ years of experience with MSc/MPH degree required; 5+ years with PhD required in HEOR or relevant related fields (health economics, epidemiology, health services research, or other research-focused public health field).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 an 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.
PREFERRED QUALIFICATIONS:Knowledge and experience in hepatology/metabolics therapeutic areas with specific MASH experience.Experience in supporting a global launch.
TRAVEL OR ENVIRONMENT REQUIREMENTS:Ability to travel internationally.Ability to work in all global time zones.Position will be based in US (Conshohocken).
Compensation: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.
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Role Overview:The Director GHEOR will support the strategic goals of the GHEOR, Global Medical Affairs (GMA), and Global Access 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.
Position Responsibilities:With HQ-based stakeholders, 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 design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies, economic models) 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.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.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 Rezdiffra 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.
Qualifications and Skills Required: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.7+ years of experience with MSc/MPH degree required; 5+ years with PhD required in HEOR or relevant related fields (health economics, epidemiology, health services research, or other research-focused public health field).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 an 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.
PREFERRED QUALIFICATIONS:Knowledge and experience in hepatology/metabolics therapeutic areas with specific MASH experience.Experience in supporting a global launch.
TRAVEL OR ENVIRONMENT REQUIREMENTS:Ability to travel internationally.Ability to work in all global time zones.Position will be based in US (Conshohocken).
Compensation: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.
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