Sr. Director, Head USA Clinical Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Enterprise Management

Job Sub Function:

R&D Management

Job Category:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

Johnson & Johnson -- About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for the Senior Director, Head USA Clinical Operations role.

The Sr. Director, Head USA Clinical Operations is accountable for the strategic and operational leadership of clinical research and development activities in the United States. This role is accountable for the successful end‑to‑end execution of all phases of clinical trials, from feasibility through close‑out, ensuring delivery against timelines, budget, quality, and compliance expectations.

 

The Sr. Director, Head USA Clinical Operations ensures full compliance with ICH‑GCP, Health Care Compliance (HCC), company SOPs, and U.S. regulatory requirements, and maintains a state of continuous inspection‑readiness. The role shapes and leads a highly complex local organization, driving execution excellence, effective issue and risk management, innovation, and capability development at scale.

 

This position has line management accountability for Functional Managers (FM), Managers of Clnical Operations (MCO), and other GCO staff in the United States, and ensures alignment of U.S. objectives with Global Development (GD), GCO, and enterprise strategies. The Sr. Director, Head USA Clinical Operations serves as a critical thought partner to global and regional leadership and may lead initiatives with scope beyond the U.S. geography.

Principal Responsibilities:

• Define and execute U.S. country strategy aligned with GD and Enterprise R&D strategies; contribute to global and regional strategy development and implementation.
• Accountable for study placement, planning, execution, and monitoring of clinical trials across all phases within the United States.
• Ensure full compliance with ICH‑GCP, SOPs, HCC policies, safety reporting requirements, and U.S. regulatory standards, maintaining inspection readiness.
• Accountable for timely identification, escalation, and resolution of quality, compliance, and operational risks, including fraud, scientific/ethical misconduct, and HCC breaches.
• Serve as primary GCO interface with U.S. Health Authorities, including FDA, for clinical operations‑related activities.
• Act as U.S. legal representative for GCO‑related activities, including authorization to sign contracts and agreements as applicable.
• Own functional budget accountability for the U.S., ensuring compliance with financial controls and driving cost efficiency initiatives.
• Build and maintain strong partnerships within GD and other U.S. teams, particularly with Medical Affairs and key R&D stakeholders.
• Contribute to enterprise leadership objectives and lead capability, process, or transformation initiatives with impact beyond the U.S.
• Develop and sustain U.S. country capabi