Executive Director, Operations Lead

Madrigal Pharmaceuticals•Waltham, PA

About The Position

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. The Executive Director, Operations Lead is accountable for the management of clinical trials and programs across the product life cycle as well as the resourcing, development, training and management of a successful clinical operations team.

Requirements

Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferred.
A minimum of 10 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late stage clinical trials.
In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
Relevant therapeutic area experience coupled with experience with pivotal, multi-site, multi-national clinical trials.
Experience with global drug development and NDA filing; experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents.
Experience collaborating closely with cross functional teams to meet study deliverables on time and on budget.

Responsibilities

Create, execute and proactively manage clinical trial processes from initial study planning to implementation and conduct through final close-out.
Define the tactics and manage the daily operational activities to ensure that timelines and deliverables are consistently met.
Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met.
Establish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines.
Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate.
Demonstrated ability to review proposals and budgets from potential CRO partners as a part of the selection process.
Participate in proposal review meetings for CRO selection.
Review and collaborate to negotiate investigator grant budgets to ensure consistent with protocol-required tests and procedures and representative of fair market value in accordance with Madrigal standards.
Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, Board of Directors and other key internal stakeholders.
Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff.
Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards.
Mentor clinical operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness.
Assist the QA department in the development, review and updating of clinical SOPs.
Accountable for the authorship of operational sections of protocols and investigator brochures, and leading the identification of and interaction with investigative sites and investigators, including study execution.
Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.
Coordinate with Biometrics to deliver high quality data deliverables on time and on budget (e.g. development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.).
Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies.
Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.