Sr. Director, Head USA Clinical Operations

Job Overview We are searching for the best talent for the Senior Director, Head USA Clinical Operations role. The Sr. Director is accountable for strategic and operational leadership of clinical research and development activities in the United States, ensuring execution of all phases of clinical trials from feasibility through close‑out while meeting timelines, budget, quality, and compliance expectations. 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. Additional duties may be assigned. Principal Relationships Reports to: VP, Regional Head, Americas GCO Interfaces: Functional Managers, Managers of Clnical Operations, Regional GCO Leadership, Other Country Heads, Global Development Leadership, U.S. 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 and Preferred Skills Required: 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. Preferred: None specified. Compensation and Benefits The anticipated base pay range for this position is: $196,000.00 – $342,700.00. Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), the Company’s long‑term incentive program, and receive the following time‑off benefits: Vacation – 120 hours per calendar year; Sick time – 40 hours per calendar year (state‑specific variations noted); 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; Caregiver Leave – 80 hours in a 52‑week rolling period; Volunteer Leave – 32 hours per calendar year; Military Spouse Time‑Off – 80 hours per calendar year. Equal Employment Opportunity Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Johnson&Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr 6084-Janssen Research & Development, LLC Legal Entity