Madrigal Pharmaceuticals

• Partner with Compliance and Legal team members to maintain and enhance infrastructure that supports a culture of compliance • Project management tied to legal and compliance operational excellence • Collaborate cross-functionally to identify policy and guidance needs; develop and refine policies, procedures, and documentation • Lead design, implementation, and continuous improvement of risk-based compliance training programs • Support the annual compliance risk assessment process • Provide practical compliance guidance to business stakeholders • Drive continuous improvement initiatives

• Lead analytics for national payer and PBM accounts, including coverage quality, utilization management, approval rates, time to therapy, abandonment, and pull-through • Monitor performance against contracts, forecasts, and access objectives; identify gaps, risks, and opportunities • Oversee rebate validation, contract performance, and downstream analytics to ensure alignment with financial and contractual terms • Partner with Pricing & Contracting on accruals, forecasting, reconciliation, and gross-to-net performance; resolve discrepancies with clear recommendations • Develop and maintain dashboards, QBRs, executive updates, formulary trackers, and standardized reporting tools • Conduct root-cause analyses of access challenges across payer, provider, field, patient support, specialty pharmacy, and claims data • Collaborate with Field Reimbursement, Specialty Pharmacy, Trade, RADs, KADs, and Sales to convert payer wins into real-world access • Support pre-deal analytics and scenario modeling to ensure future contracts align with access, operational, and financial goals • Translate complex data into clear, actionable insights for leadership and cross-functional teams • Support payer, PBM, and GPO engagements with performance insights and business reviews • May directly manage a select payer account

Role Description The Madrigal MSL will build scientific partnerships with Healthcare Professionals and decision makers using evidence-based science and non-promotional scientific exchange across Northwest Italy (Piedmont, Liguria, Lombardy, Valle d'Aosta and Sardinia). The MSL will serve as a point of contact for the latest scientific and clinical information regarding Madrigal’s novel NASH research program to thought leaders, academic centers, community group practices and regional professional organizations. The MSL will report external insights to better understand MASH diagnosis and treatment landscape. Strategically support the development and utilization of disease state educational materials in the field as needed through disease education, scientific collaboration, clinical trial support, and scientific exchange. Key Responsibilities - Identify, develop and maintain relationships with leading influential experts, key thought leaders (TLs) and health care professionals (HCPs) in fields of medicine or research relevant to the NAFLD/NASH. - Build peer to peer relationships with TLs and HCPs. - Identify and engage key TLs, HCPs, and investigators in proactive scientific exchange on disease landscape and reactive exchange on mode-of-action and clinical data. - Represent the company at selected scientific congresses and professional society meetings. - Deeply understand the fatty liver therapeutic area (NAFLD/NASH), key stakeholders, and healthcare landscape (i.e. reimbursement/access, diagnostic, testing) in your region. - Help execution of medical plans by representing the medical expertise in NAFLD/NASH and through scientific engagement with medical community in Hepatology and Gastroenterology. - Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations or symposium. - Collaborate with other internal team members (i.e., commercial, payer/access, clinical development) to share regional insights/learnings and contribute to respective strategies. - Assist in the scientific training for Commercial and other internal colleagues regarding products and the conditions they treat utilizing approved materials. - Provide scientific expertise and support for speaker training and advisory boards as requested. - Respond to external inquiries and deliver appropriate clinical and scientific information. - Develop and deliver scientific trainings. - Gather careful information from TLs/HCPs and report back to help develop clinical, as well as commercial strategy. - Operate in a highly ethical manner and comply with all laws, regulations and policies. - Complete mandatory training in assigned timelines upon hire as well as when new policies, SOP’s, guidance are issued. - Adhere to internal standard processes and comply with regulatory and compliance. - Working knowledge of relevant research procedures as well as EMA and other ethical guidelines relevant to the pharmaceutical industry. Qualifications - 3+ years medical field experience (MSL or similar). - Advanced degree in healthcare or science-related area of study (e.g., MD/DO, PharmD, PhD, DNP, PA-C) or other life sciences or equivalent with solid medical/technical background. - Hepatology / Gastroenterology and/or Fatty Liver experience strongly preferred. - Working knowledge of regulatory, health technology assessment and disease management for NAFLD/NASH strongly preferred. - Ability to function well, both independently and within a team setting, in a dynamic, fast paced environment. - Team oriented and ability to work collaboratively towards common goals. - Ability to exhibit an entrepreneurial mindset and proactive approach, demonstrating ownership, adaptability to change, and effectiveness within a rapidly growing organizational environment. - Ability to deeply understand and convey emergent scientific information. - Good interpersonal skills, including communication, presentation, persuasion, and influence. - Proficiency with technology – computers, video conferencing, key software (e.g., Microsoft Office, CRM tools). - Willing to travel internationally. - Fluent in English & local language. Benefits

• Lead and mature our global PV Quality function • Provide strategic direction and operational Quality leadership in pharmacovigilance activities • Partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial teams • Shape risk-based PV QA systems, and mentor a team committed to patient safety practices • Establish product-specific quality strategies and maintain inspection readiness • Support rapid response to product quality concerns

• Own QMS process design, harmonization, and operational excellence roadmap • Establish standards, templates, and governance for core QMS processes • Lead adoption of best practices across the Quality organization • Maintain readiness for audits and inspections through strong governance discipline

• Lead quality oversight of non-clinical studies conducted at CROs, contract laboratories, bioanalytical laboratories, toxicology sites, and other external partners supporting development programs • Develop and maintain a risk-based vendor oversight model • Plan, conduct, and manage GxP audits • Lead investigations, root cause analysis, and CAPA activities associated with non-clinical quality events and vendor performance issues • Maintain inspection readiness for non-clinical activities • Provide guidance and training to internal teams and external partners • Contribute to the design, implementation, and continuous improvement of phase-appropriate QMS processes

• Responsible for quality oversight of external GMP manufacturers • Serve as primary quality liaison across internal functions and external partners • Drive quality strategy and enable risk-based decision-making • Lead continuous improvement initiatives • Maintain inspection readiness through strong documentation control

• Responsible for GCP/Clinical Quality Assurance activities • Ensure quality and compliance of Madrigal-sponsored clinical trials • Develop, implement, and/or maintain clinical quality systems and processes • Align organization to ICH in implementing a quality culture • Engage partnership with external clinical trial vendors • Conduct or manage internal/external audits • Lead reviews, manage documentation, and track Observations/Findings • Review key clinical program or study documents

Title: Senior Manager, Analytical Manufacturing Science and Technology (MSAT) Location: PA - Conshohocken Full time Job requisition id JR_000697 Job Description: Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Position Summary: The Senior Manager, Analytical Manufacturing Science and Technology (MSAT) – is a key member of the MSAT team responsible for managing and supporting analytical activities across contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs) for commercial small molecule products. This role ensures analytical method robustness, compliance, and timely product release while leading technical investigations and supporting method transfers in a fully outsourced environment. The role reports to the Associate Director, Analytical MSAT and serves as the primary analytical liaison with external partners. Key Responsibilities: External Partner Analytical Oversight - Act as the day-to-day analytical operations lead for assigned small molecule and oral solid commercial products at CMOs and CTLs. - Ensure contract partners execute analytical testing (release, stability, in-process) in compliance with current Good Manufacturing Practices (cGMP) and company standards - occasional support outside standard business hours may be required to address critical manufacturing or quality events. - Review and approve test results, stability reports, and method execution documentation from external labs. Analytical Method Lifecycle & Technology Transfer - Support analytical method transfer, bridging, and revalidation activities between third-party sites. - Coordinate and review transfer protocols, reports, and gap assessments with external partners. - Monitor method performance across sites and batches; lead troubleshooting efforts as needed. Investigations & Deviation Resolution - Oversees analytics-driven risk assessments, trend analysis, and CAPA effectiveness to ensure issues do not repeat. - Lead or support the resolution of analytical deviations, OOS, OOT, and lab errors at CMOs/CTLs. - Utilize structured root cause analysis tools (5 Whys, Fishbone diagrams) and Six Sigma problem-solving methodologies (e.g., DMAIC, Pareto analysis) to investigate and resolve issues. - Drive CAPA development and implementation; ensure timely closure in collaboration with Quality. Compliance & Documentation - Ensure all analytical operations at contract sites meet applicable ICH, FDA, EMA, and global regulatory standards. - Maintain and review GMP documentation including method validation reports, stability protocols, technical memos, and deviations. - Participate in audit support and inspection readiness efforts, providing analytical expertise as needed. Cross-Functional Collaboration - Serve as the key point of contact for analytical topics in collaboration with QA, Regulatory CMC, Supply Chain, and Technical Operations. - Support post-approval changes by coordinating analytical data and contributing to regulatory filings. - Participate in analytical risk assessments and provide input for change controls affecting commercial methods or testing sites. Qualifications: - BS/MS/PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field. - Minimum of 8+ years (BS), 6+ years (MS) of experience in analytical development, QC, or MSAT in a GMP-regulated small molecule environment. - Strong background in managing analytical activities at CMOs/CTLs for commercial products. - Technical expertise in chromatographic methods (HPLC/GC), dissolution testing, stability programs, and compendial testing. Preferred Experience: - Six Sigma training or certification (Green Belt preferred). - Hands-on experience with method transfers and managing external lab performance. - Familiarity with fully outsourced manufacturing models and virtual pharma structures. - Experience supporting regulatory submissions (e.g., NDA supplements, variations) and inspection readiness. Location & Travel Requirements: - US Remote - Up to 50% travel to manufacturing sites across the supply network. Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $154,000 - $188,000 per year. We comply with all applicable minimum wage laws. All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. 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. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts.

Role Description The Associate Director, API / Drug Substance MSAT (Small Molecule) is the internal technical authority for commercial small-molecule drug substance manufacturing executed entirely through external CMOs. This role provides end-to-end technical oversight, governance, and lifecycle stewardship to ensure robust, compliant, and reliable commercial API supply. Operating in a virtual manufacturing environment, the role focuses on technical decision-making, CMO oversight, post-approval change management, and inspection readiness, rather than hands-on process execution. The Associate Director partners closely with Quality, Supply Chain, External Manufacturing, and Regulatory CMC to manage technical risk and maintain continuity of product and process knowledge across the external manufacturing network. Key Responsibilities - Technical Authority & Governance - Serve as the internal MSAT technical owner for assigned commercial small-molecule drug substance processes. - Establish and maintain deep understanding of API synthetic routes, unit operations, impurity profiles, and control strategies. - Provide final MSAT technical assessment and recommendations for manufacturing decisions impacting product quality or supply. - CMO Technical Oversight - Act as the primary technical interface with CMOs for drug substance topics - occasional support outside standard business hours may be required to address critical manufacturing or quality events. - Review, challenge, and approve CMO-proposed technical changes, investigations, and optimization activities. - Ensure CMOs operate within the approved process and control strategy, with appropriate technical justification for deviations. - Commercial Lifecycle Management - Lead MSAT technical evaluation of post-approval changes, including site changes, raw material changes, equipment updates, and process modifications. - Ensure changes are scientifically sound, compliant, and aligned with regulatory commitments. - Drive lifecycle robustness and supply reliability through risk-based technical oversight. - Deviation, OOS & CAPA Support - Provide technical leadership for significant deviations, OOS events, and recurring trends at CMOs. - Assess root cause analyses and corrective actions for technical adequacy and long-term effectiveness. - Ensure learnings are incorporated into process understanding and governance expectations. - Inspection Readiness & Regulatory Support - Support regulatory inspections of CMOs by providing drug substance technical narratives and subject matter expertise. - Contribute technical content for regulatory submissions, responses, and variations related to commercial API manufacturing. - Ensure technical documentation and product knowledge are inspection-ready at all times. - Cross-Functional Leadership - Partner with Quality, External Manufacturing, Supply Chain, and Regulatory CMC to align on technical risk, supply strategy, and lifecycle priorities. - Represent MSAT in cross-functional governance forums and escalation discussions. - Influence external partners and internal stakeholders through technical expertise and sound judgment. - Knowledge Management - Ensure drug substance process knowledge is captured, current, and maintained across the external manufacturing network. - Oversee technical knowledge transfer when onboarding new CMOs or transferring manufacturing sites. Qualifications - PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant industry experience. - 10+ years of experience in small-molecule drug substance MSAT, technical operations, or process chemistry within commercial manufacturing. - Demonstrated experience operating in virtual or CMO-centric manufacturing models. - Strong understanding of GMP and regulatory expectations for commercial API manufacturing. Preferred Qualifications - Experience supporting regulatory inspections at CMOs. - Proven track record managing post-approval changes in commercial portfolios. - Experience overseeing multiple CMOs or global manufacturing networks. Key Competencies - Technical authority and risk-based decision-making. - Ability to lead without direct control in a virtual organization. - Strong scientific judgment and attention to detail. - Clear, concise technical communication suitable for regulators and senior leadership. - Executive-level presence appropriate for Associate Director. Location & Travel Requirements - US Remote. - Up to 50% travel to manufacturing sites across the supply network. Benefits - Comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings. - Equity opportunities that align individual and company performance. - Mental health benefits through our Employee Assistance Program for employees and their family. - Additional voluntary benefits like supplemental life insurance and legal services.