Senior Director Clinical Operations

Temple University's Lewis Katz School of Medicine is searching for a Sr. Director of Clinical Operations!

Salary Range: $130,000 - $150,000

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 retentio