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:

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 capabilities for effective study placement and delivery at scale.
• Accountable for site strategy and site selection to meet U.S. commitments and portfolio priorities.
• Lead governance of quality, compliance, and operational performance metrics, ensuring robust follow-up and corrective actions.
• Lead or support evaluation and rollout of new processes, standards, and innovations in clinical trial execution across GCO.
• Foster a culture of continuous improvement, innovation, and accountability within the U.S. GCO organization.
• Model Credo-based leadership behaviors and an inclusive, performance-driven culture.
• Shape the external clinical trial environment in the United States, including engagement with sites, regulators, and industry stakeholders; may participate in or lead industry forums.
• Provide line management and leadership development for GCO staff up to Director level; ensure succession planning and robust development pipelines.
• Forecast and manage U.S. resource needs, aligned with portfolio demand and strategic priorities.
• Ensure effective deployment of the One Delivery Model within the U.S.
• Lead talent acquisition, development, and retention strategies for the U.S. organization.
• Mentor and support other country heads and leaders as requested.
• Lead organizational change and communicate priority shifts clearly and effectively across the U.S. organization.
• Review and approve expenses in compliance with company policy.
• Demonstrate leadership behaviors aligned with company Leadership Imperatives.
• Promote an environment of knowledge sharing and best-practice exchange internally and externally.
• Provide coaching and mentorship to senior leaders and emerging talent.

This is not an exhaustive list of responsibilities; additional duties may be assigned.

Prinicpal Relationships:

Reporting Line

• Reports to: VP, Regional Head, Americas

GCO Interfaces

• Functional Managers (FM), Managers Clinical Operations (MCO)
• Regional GCO Leadership
• Other Country Heads

Other Internal Interfaces

• Global Development Leadership across Therpautic Area-aligned Delivery Units
• R&D and U.S. leadership (including Medical Affairs)
• Central Trial Management, Delivery Units, IDAR, BRQC, HCC, External Alliances, Contracts & Centralized Services, and other GD functions

External Interfaces

• U.S. Health Authorities (e.g., FDA)
• Investigational sites and site networks
• Vendors and partners
• Industry associations and external stakeholders

Education and Experience Requirements:

• Bachelor's degree required, preferably in Life Sciences (Biology, Chemistry, Nursing, Pharmacy, or related fields)
• Advanced scientific degree and/or Master's degree preferred
• Minimum 12 years of clinical research experience within pharmaceutical industry, CRO, or investigational site environments
• Demonstrated success leading large, complex clinical operations organizations
• Strong people leadership, financial acumen, and decision-making skills
• Proven ability to drive transformation, manage complexity, and operate effectively in matrixed environments
• Deep knowledge of clinical development, U.S. regulatory requirements, ICH-GCP, and HCC standards
• Influential communicator with strong external presence
• Proficiency in English; strong interpersonal, organizational, and negotiation skills

Required Skills:

Preferred Skills:
Budget Management, Business Planning, Competitive Landscape Analysis, Corporate Management, Customer Intelligence, Design Mindset, Developing Others, Inclusive Leadership, Industry Analysis, Interdisciplinary Work, Knowledge Networks, Leadership, Operational Excellence, Product Development, Product Development Lifecycle, Qualitative Research, Research and Development, Tactical Planning

The anticipated base pay range for this position is :
$196.000,00 - $342.700,00

Additional Description for Pay Transparency:
Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role.

[DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION]

Please use the following language:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits