Associate Director, Clinical Operations

Role Summary

Associate Director of Clinical Operations supports the operational planning, execution, and oversight of Phase I–IV clinical trials. This role is responsible for day-to-day operational management of assigned studies, with a strong focus on CRO and vendor oversight, timelines, budgets, and high-quality execution in compliance with global regulatory requirements. Working closely with the Director and cross-functional partners, the Associate Director contributes to trial strategy, proactively manages risks, and ensures delivery against program and corporate objectives. The ideal candidate is a hands-on clinical operations professional who thrives in a fast-paced, growing biotech environment.

Responsibilities

• Support and manage the operational execution of Phase I–IV clinical trials.
• Oversee day-to-day trial activities including startup, conduct, close-out, and inspection readiness for assigned studies.
• Proactively assess, manage, and communicate operational risks and issues related to clinical trial delivery.
• Ensure trials are conducted in compliance with ICH-GCP, FDA, EMA, and applicable regional regulations.
• Support CRO selection, contracting, and ongoing oversight for assigned trials.
• May serve as a key operational point of contact with CROs and vendors.
• Monitor CRO performance, timelines, deliverables, quality, and budgets, escalating issues as appropriate.
• Collaborate with CROs and vendors to resolve operational challenges and mitigate risks.
• Represent Madrigal during site interactions (e.g., SIVs, investigator meetings) as needed, with a patient-focused mindset.
• Contribute to the development, review, and maintenance of study-related documents (e.g., study manuals, monitoring plans, tracking tools, informed consent forms).
• Support the preparation and review of regulatory submissions.
• Coordinate and support trial-level meetings and deliverables.
• Assist with site identification, feasibility, activation, enrollment, and retention strategies.
• Collaborate with Data Management on CRF design, study tools, EDC/IVRS specifications, and UAT activities.
• Ensure timely resolution of CRF data queries in collaboration with CRAs and Data Management.
• Coordinate and oversee Investigational Product logistics, accountability, and reconciliation.
• Support management of study budgets and site/vendor payment processes.
• Assist in managing clinical trial vendors (e.g., IVRS, central labs, IRBs, central ECG) in collaboration with the CRO.
• Partner closely with internal stakeholders including Clinical Development, Regulatory Affairs, Data Management, Project & Portfolio Management, Biostatistics, Safety, Quality, and Supply Chain.
• Provide operational input into protocol development and amendments.
• Support INDs, CTAs, and other regulatory submissions from an operational perspective.
• Support audit and inspection activities and maintain inspection readiness.
• Contribute to the development and continuous improvement of SOPs, processes, and best practices.
• Other duties as assigned.

Qualifications

• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.
• Minimum of 10–12 years of clinical trial experience.
• Experience supporting or managing Phase I–IV clinical trials.
• Experience working with CROs and external vendors.
• Experience in a rapidly growing biotech or similar dynamic environment preferred.
• Experience with first-in-human studies preferred.
• Therapeutic experience in metabolic and/or cardiovascular clinical studies preferred.

Education

• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.

Skills

• Strong understanding of clinical trial operations and GCP.
• Excellent organizational and project management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication and collaboration skills.
• Detail-oriented with a proactive, problem-solving mindset.