Senior Director Medical Affairs Spain

Madrigal is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH).
NASH is a growing global health burden in all regions of the world, but many patients with NASH remain undiagnosed.
Madrigal's novel therapeutic emerged from a research program examining the role of the thyroid hormone receptor (THR) ß pathway in liver health.
Madrigal scientists and researchers, working with leading experts in hepatology, have been studying the therapy's ability to target the underlying causes of NASH by reducing or eliminating liver fat (steatosis) as well as reducing liver inflammation, liver cell ballooning (hepatocyte cell death), and liver fibrosis that can lead to cirrhosis.
Madrigal's lead candidate, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor-ß (THR-ß) agonist designed to target key underlying causes of NASH.
There have been no prior treatments available to halt or improve fibrosis, thus resolving NASH.
Based on Phase 3 results reported to date, the U.S. FDA granted accelerated approval for their therapy for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
Madrigal is currently conducting multiple Phase 3 clinical trials to evaluate the safety and efficacy of resmetirom for the treatment of NASH, including the pivotal MAESTRO-NASH biopsy study in patients with significant fibrosis, the MAESTRO-NASH Outcomes study in patients with NASH with compensated cirrhosis and the MAESTRO-NAFLD-1 safety study.
Positive results from the pivotal MAESTRO-NASH biopsy study were published in the New England Journal of Medicine in February 2024.
The company announced recent new data from the Phase 3 MAESTRO-NASH Study of Rezdiffra presented at the EASL Congress on June 6th, 2024.
The key takeaways included :
Late-breaking AI-based analysis of MAESTRO-NASH biopsy data demonstrates Rezdiffra improved key fibrotic features that are predictive of progression to decompensated cirrhosis.Noninvasive test data through three years of treatment demonstrates durable treatment response to Rezdiffra; 91% of patients achieved improvement or stabilization of liver stiffness.First analysis of health-related quality of life data from MAESTRO-NASH demonstrates Rezdiffra improved patient worry, health distress and stigma.First analysis of Rezdiffra treatment in MetALD demonstrates patients achieved similar rates of fibrosis improvement and steatohepatitis resolution compared to the NASH population.In March 2024, Rezdiffra became the first and only FDA-approved therapy for patients with NASH.
Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
Furthermore, the company has filed for MAA in March 2024, and if successful, expects to launch their product in Europe in the first half of 2025.
Rezdiffra is Madrigals' only drug that has been approved for sale and it has been approved only for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis in the United States.
The company is focusing a significant portion of their activities and resources on Rezdiffra, and they believe their prospects are highly dependent on, and a significant portion of the value of the company relates to, the ability to successfully commercialize Rezdiffra for the treatment of adults with NASH with moderate to advanced liver fibrosis in the United States and beyond.
NASH / MASH NASH is a leading cause of liver related mortality and an increasing burden on healthcare systems globally.
Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.
Once NASH progresses to significant liver fibrosis (consistent with F2 / F3) the risk of adverse liver outcomes increases dramatically :
The risk of liver-related mortality and other liver-related events (e.g.
transplant) increases meaningfully in patients with increasing degrees of liver fibrosis.
Patients with significant liver fibrosis have an approximately 10-17X increased risk of liver-related mortality versus patients without liver fibrosis.NASH is rapidly becoming the leading cause of liver transplantation in the U.S.People with NASH have an increased risk of heart attack, stroke and death.In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis.
Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD), NASH was renamed MASH, and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver.
In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes).
Bill Sibold, Madrigal CEO, recently highlighted "Madrigal is the first company to deliver an approved therapy for patients with NASH, which we believe will give us a strong competitive advantage for many years to come.
As a once-daily, well-tolerated, liver-directed, oral medicine that has demonstrated unprecedented efficacy in a pivotal Phase 3 trial, Rezdiffra is well positioned to become the foundational therapy for this serious disease." He continued, "We are focused on executing this first-in-disease launch, where our expert team is partnering with the NASH community to establish treatment pathways for patients, laying the groundwork for our long term leadership".
Purpose of the Position The Senior Director Medical Affairs, Spain is the Senior Medical Leader for Madrigal Pharmaceuticals in Spain, overseeing all aspects of the Medical Affairs and acting as the primary contact for Medical Affairs in the country.Key responsibilities include developing and executing the Medical Affairs strategy tailored for Spain, ensuring a compliant and high-performing Medical Affairs organization and successful launch of resmetirom.The role involves representing local needs and opportunities within regional and global contexts, serving on Spain's Leadership Team, and representing Madrigal Pharmaceuticals in external engagements requiring the presence of the Spain's Senior Medical Leader.Contributing Member of the European Global Medical Affairs Team.Key Responsibilities
Develops and Executes Medical Affairs Strategy : Strategically develops and executes Medical Affairs (MA) plans, ensuring alignment with local needs and global strategies.Delivers tactical plans for company's therapeutic area, adhering to regulatory requirements and Standard Operating Procedures (SOPs).Engages with Key External Stakeholders : Act as the primary external interface with stakeholders including insurers, government leaders, professional societies, and medical-scientific institutions.Leads and executes medical research and implementation strategies for Madrigal Pharmaceuticals' products.Ensures engagement with the medical community through scientific advisory boards, stakeholder engagements, webinars, and presentations.Collaborates Across Functions : Partners with Global Medical Affairs, Market Access, and Commercial teams to engage payers, policymakers, and decision-makers in support of Madrigal's products.Builds and maintains relationships with scientific leaders relevant to current and future needs.Gathers local insights from healthcare providers (HCPs) and patients to inform regional and global strategies.Provides insights and contributions to the Spanish affiliate which ultimately help it to achieve its financial commitments to the company.Oversight and Management : Provides oversight to Spain's Medical Team (Medical Science Liaisons / Medical Advisors), ensuring robust and compliant activities supporting scientific exchange.Manages Compassionate Use Requests, patient access programs, and similar initiatives.oversees Investigator-Initiated Studies (IIS) in collaboration with global MA and other relevant teams.Medical Expertise and Leadership : Provides medical expertise to commercial product teams to enhance scientific and medical value.Contributes to outcomes research, health economics engagements, and epidemiologic studies with national payers and regulatory agencies.Talent Development : Proactively manages and develops talent within the Medical Affairs organization.The Candidate
Experience and Professional Qualifications
A minimum of 5-10 years of global biopharmaceutical industry experience in clinical development and / or medical affairs with demonstrated track record of success.A minimum of 3-5 years of people-management experience in pharmaceutical industry.Demonstrated organizational skills, including ability to set goals and align priorities.Deep experience in the applicable therapeutic area (e.g., metabolic diseases, diabetes, obesity)Preferred : Additional advanced degrees, entry on a specialist register (pharmaceutical medicine or a relevant clinical specialty) and a current 'license to practice' are a strong plus.Specialty clinical training (i.e., a residency + / - fellowship)Over 10 years of experience in medical affairsSeniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Health Care Provider
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