Jobs at Madrigal Pharmaceuticals

Leads U.S. tax operations and global tax reporting infrastructure, including ASC 740 tax provisions, compliance, audit readiness, SOX controls, tax technology, and external advisor management. Oversees tax filings, international tax reporting, R&D credit processes, technical tax analyses, financial statement disclosures, and process improvements. Advises Finance and senior leaders on tax risks, business impacts, and recommendations while building scalable, technology-enabled tax operations.

Leads U.S. HCP marketing strategy and execution for Rezdiffra, including brand positioning, promotional content, omnichannel campaigns, KOL and congress engagement, sales enablement, analytics, and regulatory-compliant review. Partners cross-functionally with Sales, Medical Affairs, Market Access, Legal, and Regulatory. Manages marketing staff, budgets, agencies, performance reporting, and commercial optimization while supporting the growth of a specialty pharmaceutical brand.

Leads clinical trial operations across the product lifecycle, from study planning through closeout, ensuring quality, timelines, budgets, compliance, and inspection readiness. Oversees clinical operations strategy, CRO and investigator relationships, protocol and regulatory document development, data deliverables, regulatory submissions, and clinical operations staffing. Mentors and develops the team while collaborating with cross-functional leaders, executive stakeholders, regulators, and external partners.

Provides strategic leadership for global clinical trial participant recruitment, engagement, diversity, and retention across Phase I-IV programs. Develops recruitment strategies, enrollment forecasts, participant-centric initiatives, health equity programs, vendor partnerships, analytics, budgets, and standardized processes. Leads cross-functional collaboration with clinical, regulatory, medical, data, legal, and patient advocacy teams while building and mentoring a high-performing recruitment organization.

Leads development quality assurance for oral pharmaceutical programs, owning quality strategy, governance, risk management, readiness milestones, QMS processes, vendor oversight, and inspection readiness. Partners with CMC and clinical supply teams on control strategy, technology transfer, issue management, and commercialization readiness. Ensures development documentation is traceable, compliant, and inspection-ready while driving cross-functional decision-making and timely action closure.

Leads development quality strategy, governance, and execution across a biopharmaceutical new product portfolio. Establishes phase-appropriate QMS standards, oversees external partners and vendors, supports inspection and submission readiness, manages quality risks, and sponsors continuous improvement. The role requires portfolio leadership, executive stakeholder influence, people management, audit readiness, change management, and proficiency with Veeva Vault Quality.

Owns technical product knowledge for small-molecule pharmaceuticals across development, technology transfer, commercial manufacturing, and lifecycle management. Maintains technical dossiers covering formulation, process design, CPPs, CQAs, controls, risks, and analytical methods. Supports CMO technology transfers, launch readiness, manufacturing investigations, change controls, CAPAs, process improvements, and inspection readiness. Coordinates cross-functional experts and ensures GMP-compliant, accurate, traceable documentation that enables manufacturing and process support.

Lead the vision and execution of AI and automation strategies across multiple sectors, ensuring integration and compliance with regulatory standards while steering teams and optimizing workflows for operational efficiency.

Provides strategic leadership and end-to-end accountability for bioanalytical sciences across clinical and nonclinical development programs. Develops bioanalytical strategies, oversees outsourced CRO partners, and ensures assay development, validation, sample analysis, data integrity, and regulatory compliance. Supports PK/PD evaluations, regulatory submissions, and agency engagement across modalities including small molecules and siRNA. Serves as an internal bioanalytical subject matter expert and collaborates with Clinical Operations, Translational Medicine, Regulatory, and R&D teams.

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.

The Key Account Director will drive access and adoption of Rezdiffra across assigned integrated delivery networks and healthcare provider groups. Responsibilities include engaging executive, pharmacy, and medical stakeholders; delivering approved product, clinical, and health-economic messaging; developing account plans; identifying market and formulary insights; coordinating cross-functional Medical, Marketing, Market Access, and Patient Support teams; managing risks; and ensuring regulatory compliance. The role requires substantial biotech or pharmaceutical account-management experience and 60–80% travel.

Manage strategic pharmaceutical accounts across regional integrated delivery networks and healthcare provider super groups. Engage executives, pharmacy directors, and medical directors to expand access and adoption of Rezdiffra. Develop account plans, deliver approved clinical and economic messaging, provide market and formulary insights, coordinate cross-functional Medical, Marketing, Market Access, and Patient Support teams, and ensure compliant execution. The role requires extensive biotech or pharmaceutical account management experience, strong planning and analytical skills, and 60–80% travel.

Leads account strategy and access for Rezdiffra across regional integrated delivery networks and large healthcare provider groups. Engages executive, pharmacy, and medical stakeholders; delivers approved clinical, branded, unbranded, and health-economic messaging; monitors market and formulary trends; develops cross-functional account plans; coordinates Sales, Medical Affairs, Marketing, Market Access, and Patient Support teams; manages risks and compliance while driving adoption and performance.

Develops and executes international pharmaceutical pricing and market access strategies across Europe and other markets. Partners with affiliate leaders and cross-functional teams on HTA submissions, pricing negotiations, reimbursement, payer engagement, value propositions, evidence planning, and launch readiness. Monitors market access environments, supports portfolio and business development decisions, and strengthens capabilities across international affiliates.

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.

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.

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.

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.