Sr. DIRECTOR CLINICAL OPERATIONS

ABOUT US: Calibr-Skaggs Institute for Innovative Medicines is a division of Scripps Research focused on innovative research in the areas of regenerative medicine, cancer biology, cardiovascular and metabolic disease, immunology and infectious disease. Our mission is to translate innovative ideas from bench to beside in collaboration with academic and pharma partners. This is enabled by our unique position between academia and pharma, allowing for a bridge to catalyze new science that can be transformative in the lives of patients. Calibr-Skaggs' lead programs include a novel "switchable" CAR-T cell therapy platform (currently in Phase I trials for hematological and solid tumors, as well as for autoimmune diseases) and our multivalent antibody platforms in Oncology and Autoimmune disease. We are recruiting talented scientists who have a passion for making a difference in the lives of patients

POSITION TITLE: Sr. Director Clinical Operations

POSITION SUMMARY:

The Sr. Director of Clinical Operations will lead and manage the planning, execution, and oversight of early- and mid-phase clinical trials across its diverse pipeline of innovative therapeutics, including biologics, cell and gene therapies, and small molecules. The successful candidate will be a hands-on operational leader with experience in managing clinical programs from IND submission through clinical readouts, with strong oversight of timelines, vendors, budgets, and regulatory compliance. This is a unique opportunity to work within a highly translational, mission-driven research institute accelerating first-in-human and proof-of-concept studies for high-impact diseases, including rare diseases, oncology, and inflammatory conditions.

RESPONSIBILITIES AND DUTIES:

Trial Execution and Oversight-

• Day to day leadership and oversight of clinical trial managers.
• Lead all aspects of clinical trial execution (Phase 1-2), including site selection, study start-up, enrollment, monitoring, and closeout
• Ensure adherence to ICH-GCP, FDA regulations, and internal SOPs
• Oversee CROs and vendors (e.g., EDC, labs, biostatistics, pharmacovigilance) to ensure quality deliverables
• Drive study timelines, budget management, and operational risk mitigation strategies
• Collaborate with regulatory, CMC, clinical development, and biostatistics to ensure end-to-end program alignment

Strategic Leadership-

• Develop and maintain operational plans for Calibr-led IND and IIT studies
• Contribute to protocol development, feasibility assessments, and operational input on study design
• Establish performance metrics, dashboards, and KPIs for trial execution
• Serve as the clinical operations point of contact in project teams and governance meetings

Team and Vendor Management-

• Build and manage a growing internal clinical operations team (CTMs, CRAs)
• Select, onboard, and oversee CROs, ensuring compliance with contracts and timelines
• Foster a culture of accountability, cross-functional collaboration, and operational excellence

Quality and Compliance-

• Lead internal inspection readiness and trial master file (TMF) oversight
• Ensure data integrity, patient safety, and regulatory audit readiness
• Support SOP development and continuous improvement initiatives

QUALIFICATIONS REQUIRED:

• Bachelor's degree in life sciences or healthcare field (advanced degree preferred)
• Minimum 10+ years of experience in clinical trial operations, including 5+ years in a leadership role
• Proven track record in early-phase trials (FIH, Phase 1-2) in biotech, pharma, or academic translational setting
• Experience managing global trials and CRO/vendor oversight
• Strong working knowledge of FDA, EMA, and ICH-GCP guidelines
• Excellent communication, leadership, and cross-functional collaboration skills
• Ability to thrive in a fast-paced, mission-driven, matrixed environment

PHYSICAL REQUIREMENTS

• May include: Stationary position for an extended period of time, traverse campus/facility as needed, operate machinery such as computer, phone, copy machine; exposure to cold or hot temperatures.
• Details of established essential functions for this position will be addressed/discussed during the interview process.

ADDITIONAL INFORMATION: This is a hybrid position, with occasional onsite requirements.

COMPENSATION: The expected hiring range for this position is $180,000 to $240,000 per year, commensurate with experience. Consideration will be given to experience that exceeds the listed requirements.

COMPREHENSIVE BENEFITS INCLUDE:

• Eligibility for retirement plans with employer contribution.
• Full suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more.
• Access to Flexible Spending Accounts (Medical/Dependent Care).
• Competitive vacation and sick leave policies.
• Free, on-site Counseling Center which provides confidential counseling services to benefits-eligible employees and their family members.
• Free, on-site parking.

The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff.

EEO Statement:

The Scripps Research Institute is an Equal Opportunity Employer. We promote diversity of thought, culture and background in the fields of science. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status.