Senior Director, Clinical Operations

Senior Director of Clinical Operations

Temple University's Lewis Katz School of Medicine is searching for a Senior Director of Clinical Operations! Salary Range: $130,000 - $150,000. Become a part of the Temple family and you will have access to a hybrid work schedule, full medical, dental, vision coverage, paid time off, federally observed paid holidays, personal days, tuition remission, a generous retirement plan, and so much more!

Position Summary: 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.

Job Details:

• This position requires the following background checks: criminal history review, child abuse clearance and FBI fingerprinting

Required Education and Experience:

• 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.

Required Skills and Abilities:

• 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.

Essential Duties:

• 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.

Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial, and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review: Annual Security Report You may request a copy of the report by calling Temple University's Campus Safety Services at 215-204-7900.

Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC) Job: Staff Schedule: Full-time Shift: Day Job Employee Status: Regular Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law.