Jobs at Madrigal Pharmaceuticals

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.

Own global API supply planning, expanding into drug product and finished goods planning across external manufacturers. Build supply plans based on demand, capacity, lead times, yields, and inventory targets; govern assumptions, parameters, master data, and auditability. Lead constraint identification, scenario modeling, risk escalation, and recovery actions. Coordinate with CMOs and cross-functional stakeholders, track planning KPIs, improve data quality and planning accuracy, and communicate risks and decisions to executives.

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.

Lead a regional team of Access and Reimbursement Managers to optimize patient access to specialty products, ensuring compliance and delivering tailored solutions in endocrinology practices.

The Quality Assurance Lead will establish a local pharmaceutical quality system, ensure compliance with GMP/GDP, and manage PEL applications and audits.

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.

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.

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.

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 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.

Serve as FP&A strategic partner to Tech Ops (CMC, Supply Chain, QA), managing budgeting, forecasting, month-end close, executive reporting, and financial analysis to support manufacturing, supply, and technical operations decisions.