Executive Director, Clinical Operations & Strategy

Madrigal Pharmaceuticals; Waltham (MA); On-site; USD 286,000 - 334,000; Full time

Benefits offered by this job

Equity

Flexible PTO

Medical, dental, vision insurance

Life/disability insurance

401(k) with employer match

Mental health benefits

Job summary

Madrigal Pharmaceuticals is seeking an Executive Director, Operations Lead in Massachusetts to oversee clinical trials and program management across the product life cycle. You will recruit, develop, and manage a successful clinical operations team, ensuring quality, timelines, and budgets across multi-site trials.

You will mentor staff, oversee quality checks, and coordinate with CRO partners while engaging with regulatory submissions and interactions with FDA/EMA.

Qualifications

• Bachelor’s degree; MS/PharmD preferred.
• 10+ years in clinical operations and strategic planning.
• Experience with multi-site, multinational trials.
• Experience with NDA/IND filings.
• Ability to lead cross-functional teams.

Responsibilities

• Create, execute and manage clinical trial processes from planning to close-out.
• Define tactics and manage daily operational activities to meet timelines.
• Provide leadership and guidance of Clinical Operations to meet quality, timelines, resources and budget goals.
• Establish performance indicators to ensure trials meet timelines.
• Collaborate with other department heads to integrate operations into development plans.
• Negotiate investigator grant budgets aligned with protocol tests and fair market value.
• Represent Clinical Operations to Executive Committee, Project Teams and Board.

Skills

Clinical ops leadership

Study planning

Budget management

Cross-functional collaboration

Regulatory inspections

Vendor management

IND/NDA filings

Team mentorship

Education

Bachelor's in Life Sciences

MS or PharmD preferred

Tools

SOPs

ICH-GCP

Job description

Madrigal Pharmaceuticals is seeking an Executive Director, Operations Lead in Massachusetts to oversee clinical trials and program management across the product life cycle. You will recruit, develop, and manage a successful clinical operations team, ensuring quality, timelines, and budgets across multi-site trials.

You will mentor staff, oversee quality checks, and coordinate with CRO partners while engaging with regulatory submissions and interactions with FDA/EMA.