Senior Director, Clinical Operations - Global Trials Leader

Madrigal Pharmaceuticals Inc.; Conshohocken (Montgomery County); Hybride; USD 262 000 - 307 000; Plein temps

Avantages offerts par ce poste

Equity

Flexible PTO

Medical/Dental/Vision

401(k)

Résumé du poste

Madrigal Pharmaceuticals Inc. is seeking a Senior Director, Clinical Operations to provide strategic and operational leadership for global Phase I‑IV trials.

You will oversee complex programs, manage CROs and vendors, ensure regulatory compliance, and drive delivery within timelines and budgets. The role leads cross-functional teams, mentors operations staff, and shapes scalable processes in a fast-paced biopharma environment.

Qualifications

• 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.

Responsabilités

• Provide strategic and operational leadership across global Phase I-IV clinical development programs.
• Oversee studies to ensure execution according to priorities, milestones, quality standards, timelines, and budgets.
• Lead planning and execution of complex trials from study start-up through closeout.
• Develop robust operational strategies and accelerated delivery plans to support development objectives.
• Identify, assess, and manage operational risks impacting study and program delivery.
• Ensure trials are conducted in compliance with ICH‑GCP, FDA, EMA, and 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 via KPIs, governance, quality metrics, timelines, budgets.
• Drive proactive issue resolution and risk mitigation across CROs, vendors, and internal stakeholders.
• Represent Madrigal during investigator meetings, Site Initiation Visits, governance meetings, and external interactions.
• Partner with Clinical Development and cross-functional teams to influence protocol development, study design and execution strategies.
• Provide strategic oversight for study-related documents including plans, monitoring plans, site manuals, ICFs.
• Provide operational leadership supporting INDs, CTAs, protocol amendments, and regulatory submissions.
• Lead and manage trial level meetings and deliverables.
• Develop global site identification, feasibility, activation, enrollment, and retention strategies.
• Collaborates with data management on CRFs, study guides, binders, diaries, and forms; participate in EDC/IVRS processes.
• Ensure timely resolution of CRF queries with CROs and data management.
• Coordinate Investigational Product including accountability and reconciliation.
• Manage study budgets and payments to all clinical trial vendors.
• Provide oversight of vendors including labs, imaging, ECG, IRT, eCOA, and IRBs.
• Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and Supply Chain.
• Provide input into development strategy, study design, portfolio planning, and resource forecasting.
• Support regulatory submissions from an operational perspective.
• Ensure ongoing inspection readiness and support audits and inspections.
• Develop and maintain SOPs and best practices for a growing biotech company.
• Provide line management, coaching, and career development for Clinical Operations staff.
• Other duties as assigned.

Connaissances

Strategic leadership

CRO oversight

Vendor management

Project management

Stakeholder management

Formation

Bachelor’s degree

Advanced degree preferred

Outils

CTMS

EDC

eTMF

IRT

Description du poste

Madrigal Pharmaceuticals Inc. is seeking a Senior Director, Clinical Operations to provide strategic and operational leadership for global Phase I‑IV trials.

You will oversee complex programs, manage CROs and vendors, ensure regulatory compliance, and drive delivery within timelines and budgets. The role leads cross-functional teams, mentors operations staff, and shapes scalable processes in a fast-paced biopharma environment.