Senior Director Clinical Operations

Temple University•Philadelphia, PA

22d•$130,000 - $150,000

About The Position

The Senior Director of Clinical Research Operations will be responsible for program operations, key performance tracking, staff management, daily operations, resource allocation, scheduling and reallocation and deployment of services as needed. They will lead the planning, execution, and operational excellence of clinical trials from concept through closeout, ensuring compliance, quality, and timely delivery across all research initiatives. This role is responsible for ensuring the delivery of high-quality clinical trials that are on time, within budget, and in compliance with all regulatory requirements. The Senior Director Clinical Research Operations is responsible for ensuring the clinical research infrastructure provides efficient, compliant, and customer service-oriented support to meet the needs of the research community. The position will provide leadership to a multidisciplinary team and collaborate cross-functionally with stakeholders in medical, regulatory, quality, data management, and executive leadership.

Requirements

Advanced degree in medicine, pharmacy, nursing, or related field (e.g., M.D., RN, PharmD). An equivalent combination of education and experience may be considered.
10+ years of experience in clinical research, with at least 5 years in a leadership role.
Strong knowledge of regulatory requirements (FDA, OHRP, NIH, HIPAA, ICH-GCP).
Proven experience leading large, cross-functional clinical research teams in an academic or healthcare setting.
Demonstrated ability to manage large-scale clinical trial portfolios, budgets, and performance metrics.
Strong leadership, management, and team-building skills.
Excellent communication and interpersonal skills.
Ability to work in a fast-paced, high-growth environment.
Strategic thinker with attention to operational detail.

Responsibilities

Strategic Leadership & Operations Management:
Provide visionary leadership for all clinical research operations within the School of Medicine.
Develop and implement SOPs, operational policies, and strategic plans that align with institutional research objectives and regulatory requirements.
Lead the strategic planning and development of best-in-class clinical research infrastructure.
Clinical Trial Oversight:.
Ensure that clinical trials meet enrollment targets, timelines, and deliverables.
Monitor and report on key performance indicators and operational metrics.
Team Leadership & Staff Development:
Lead, mentor, and develop a high-performing team, including Clinical Research Nurses, Coordinators, Regulatory Specialists, Research Administrators, and support staff.
Develop and apply a competency framework and career ladder for research staff.
Ensure performance management, staff retention, and professional development across the clinical research enterprise.
Collaborate with Human Resources on recruitment, onboarding, retention, and professional development initiatives.
Quality, Compliance & Process Improvement:
Ensure strict adherence to FDA, HIPAA, GCP, IRB, and institutional regulatory standards.
Lead responses to audits (internal, external, and regulatory) and implement corrective actions as needed.
Promote a culture of continuous improvement through data-driven decision-making, quality assurance activities, and SOP development.
Collaboration & Institutional Engagement:
Foster strong internal and external partnerships with investigators, sponsors, and regulatory bodies.
Represent the School of Medicine on institutional committees, task forces, and external collaborations to advance clinical research.
Assist in institutional and new business development initiatives including increasing industry-sponsored trials and enhancing NIH funding capabilities.
Program and Resource Management:
Oversee daily operations, resource allocation, financial planning, and service deployment.
Develop and execute staffing and monitoring plans to support current and future research demands.
Submit regular reports to senior leadership regarding research performance, strategic progress, and resource utilization.
Performs other duties as assigned.