Senior Director, Clinical Operations

Madrigal Pharmaceuticals•Waltham, PA

11d

About The Position

The Senior Director, Clinical Operations provides strategic and operational leadership for the planning, execution, and oversight of global Phase I-IV clinical trials and clinical development programs. This role is accountable for the successful delivery of one or more complex clinical programs from study start-up through closeout, ensuring execution against timelines, quality, budget, and corporate objectives while maintaining compliance with global regulatory requirements. The Senior Director, Clinical Operations will drive operational strategy across a portfolio of studies while partnering closely with Clinical Development and cross-functional leadership to support the Company’s development objectives. This individual provides organizational leadership, line management, and mentorship to Clinical Operations staff, while building scalable processes and operational excellence within a rapidly growing biotechnology environment. The ideal candidate is an experienced clinical operations leader who thrives in a fast-paced organization and has demonstrated success leading global clinical development programs, developing high-performing teams, and driving execution across complex cross-functional initiatives.

Requirements

Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.
Minimum of 15 years relevant overall experience and 12 - 15 years of progressive clinical trial operations experience, preferably within biotechnology or pharmaceutical industry settings.
Demonstrated experience managing Phase I-IV clinical trials.
Experience in a rapidly growing biotech or similarly dynamic environment preferred.
Experience with first-in-human studies is strongly preferred.
Therapeutic experience in metabolic and / or cardiovascular clinical studies is preferred.
Strategic leadership with the ability to align operational execution to corporate development objectives.
Comprehensive understanding of global clinical trial operations, ICH-GCP, FDA, EMA, and international regulatory requirements.
Proven CRO oversight and vendor management capabilities.
Experience working in core systems such as CTMS; eTMF; EDC; IRT.
Excellent project management, organizational, and decision-making capabilities.
Strong financial management, forecasting, and budget oversight skills.
Strong leadership presence with exceptional communication, influencing, negotiation, and stakeholder management skills.
Commitment to building high-performing teams and fostering a culture of collaboration, accountability, and continuous improvement.
Comfortable working in a fast-paced, evolving environment.

Nice To Haves

Advanced degree (MS, MPH, PharmD, PhD) preferred.
Experience in a rapidly growing biotech or similarly dynamic environment preferred.
Experience with first-in-human studies is strongly preferred.
Therapeutic experience in metabolic and / or cardiovascular clinical studies is preferred.

Responsibilities

Provide strategic and operational leadership across one or more global Phase I-IV clinical development programs.
Provide portfolio oversight to ensure studies are executed according to corporate priorities, development milestones, quality standards, timelines, and budgets.
Lead operational planning and execution of complex clinical trials from study start-up through closeout.
Develop robust operational strategies and accelerated delivery plans to support corporate development objectives.
Embrace an ownership mindset by proactively identifying, assessing, managing, and communicating operational risks impacting study and program delivery.
Accountable to ensure trials are conducted in compliance with ICH-GCP, FDA, EMA, and applicable regional regulations.
Lead CRO selection, contracting, and ongoing oversight for responsible trials.
Serve as the primary operational liaison with CROs and key vendors.
Monitor CRO and vendor performance through key performance indicators, governance meetings, quality metrics, timelines, budgets, and operational deliverables.
Drive proactive issue resolution and risk mitigation across CROs, vendors, and internal stakeholders.
Represent Madrigal during investigator meetings, Site Initiation Visits, governance meetings, and key external interactions, maintaining a patient-focused approach.
Partner with Clinical Development and cross-functional teams to influence operational aspects of protocol development, study design, feasibility assessments, and execution strategies.
Provide strategic oversight for study-related documents including operational plans, monitoring plans, site manuals, project tools, informed consent forms, and other essential trial documentation.
Provide operational leadership supporting INDs, CTAs, protocol amendments, investigator brochures, and other global regulatory submissions.
Lead and manage trial level meetings and deliverables.
Develop and oversee global site identification, feasibility, activation, enrollment, and retention strategies.
Collaborates with data management in the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT.
Ensure timely resolution of CRF queries through collaboration with CROs, Clinical Data Management, and study teams.
Coordinates and oversees Investigational Product including overall accountability and reconciliation.
Manages and/or oversees study budget and payment process for all clinical trial vendors including investigative sites.
Provide strategic oversight of all clinical trial vendors including central laboratories, imaging vendors, ECG providers, IRT, eCOA, IRBs, and specialty vendors.
Partners closely with internal partners such as Clinical Development, Regulatory Affairs, Data Management, Project and Portfolio Management, Biostatistics and Data Science, Safety, Quality, and Supply Chain Planning & Operations.
Provide operational input into clinical development strategy, study design, portfolio planning, and resource forecasting.
Supports INDs, CTAs, protocol amendments, and other regulatory submissions from an operational perspective.
Ensures ongoing inspection readiness at the study, site, and vendor levels.
Supports audits and regulatory inspections.
Helps to develop, implement, and maintain SOPs and best practices appropriate for a rapidly growing biotech organization.
Provide line management, coaching, mentoring, performance management, and career development for Clinical Operations staff, fostering a high-performing, collaborative culture.
Other duties as assigned.