Jobs at Madrigal Pharmaceuticals

Lead and execute statistical programming across clinical development: develop, validate, review, and maintain SAS programs; review SDTM/ADaM/TLFs and Define.xml; support NDA/BLA submissions and submission validation; establish programming standards, QC procedures, and automation; and coordinate work with biostatisticians, CROs, and cross-functional teams.

Lead end-to-end data management for clinical studies including DMPs, EDC setup and UAT, query management, external data integrations, data cleaning, metrics monitoring, database lock, vendor oversight, and cross-functional collaboration to ensure regulatory-compliant, high-quality trial data.

Lead GMP API Quality Assurance for external CMOs/CDMOs, owning API quality strategy, oversight of batch review, deviation/CAPA, change control, inspection readiness, partner governance, tech transfer support, and mentoring QA staff to ensure ICH Q7 and global GMP compliance.

Provide high-level administrative and operational support to the EVP, Technical Operations and leadership team. Manage complex executive calendars, travel, expenses, leadership meetings, cross-functional projects, and confidential information. Act as trusted liaison, enabling operational execution, mentoring administrative staff, and supporting continuity in a fast-paced biotech environment.

Lead global logistics strategy and execution for temperature-controlled pharmaceutical shipments. Own carrier/forwarder governance, lane performance and cost-to-serve optimization, GDP-aligned shipment controls, disruption response and contingency planning, audit readiness, and cross-functional escalation and reporting.

Lead global supply chain operational excellence and digital enablement to standardize SOPs, run a continuous improvement pipeline, automate workflows, and build KPI routines. Partner with IT/Analytics to deliver dashboards, training, and adoption tracking, ensure sustainment through controls, and drive capability building in structured problem solving across global teams.

Manage daily 3PL operations, ensure compliance, coordinate order fulfillment, monitor service performance, and drive continuous improvement for logistics.

Field-based Access and Reimbursement Manager providing provider-facing support to ensure patient access to a specialty pharmacy product. Duties include benefits investigation, prior authorizations, appeals, education/training for HCPs, collaboration with internal teams, escalation of access barriers, and using data to identify trends and report progress. Requires extensive payer and specialty pharmacy liaison work.

Execute GMP batch disposition and release for APIs and intermediates by reviewing batch records, CofAs, and release packages against approved specifications. Coordinate resolution of deviations, OOS/OOT investigations, and documentation gaps with CMOs/CDMOs. Maintain inspection-ready release records in Veeva, track release metrics, drive right-first-time improvements, support change controls, and partner with MSAT, Supply Chain, and Regulatory to ensure supply continuity.

The Associate Director, Marketing KOL Engagement will lead healthcare professional engagement initiatives, manage speaker bureau programs, and develop peer-to-peer educational strategies to enhance brand adoption and advocacy for Rezdiffra.

The Director, Global Publications Lead manages scientific publications for Madrigal, ensuring alignment with medical affairs strategies, compliance, and impactful communication with stakeholders.

Serve as the technical lead for enterprise finance systems, administering and optimizing NetSuite, Coupa, Concur, and Workiva. Drive finance technology implementations, automation, reporting improvements, and SOX-compliant controls. Liaise between Finance, IT, vendors, and global stakeholders to manage upgrades, reconciliations, documentation, training, and audit support.

Provide site-facing MSAT leadership and technical oversight for assigned API CMO(s). Monitor performance, coordinate investigations and CAPAs, lead transfer and change readiness, assess technical risk, drive partner improvements, and maintain inspection-ready documentation and knowledge management.

The Executive Director, Strategic Projects will drive commercial strategy execution and cross-functional collaboration within Madrigal, ensuring operational excellence and leading high-priority initiatives.

Lead and mature the global Pharmacovigilance Quality function, ensuring compliance and efficient operations, while mentoring a global team.

The role involves overseeing GCP quality assurance activities for clinical trials, ensuring compliance with regulations and industry standards, managing vendor quality, and leading quality events and process improvements.

The Senior Director, Legal and Compliance Operations ensures effective implementation of compliance initiatives, policy governance, and operational excellence in compliance practices, while collaborating closely with various functional teams to support business objectives and maintain a culture of integrity.

Lead QMS process design and operational excellence for a biopharmaceutical company, ensuring compliance, efficiency, and continuous improvement from development to commercial operations.

The Senior Biostatistician will perform statistical modeling and analyses, design clinical trials, and collaborate with cross-functional teams to support R&D objectives in biopharmaceuticals.

Lead ADME strategy and execution for nonclinical and clinical programs. Design, oversee, and interpret in vitro and in vivo ADME studies, manage CROs, perform DDI risk assessment and PBPK modeling, integrate PK data to inform development, and author ADME regulatory sections supporting submissions and interactions.