Senior Director, Clinical Operations

• Provide strategic and operational leadership across multiple clinical trials or a full clinical program
• Set clinical operations strategy for assigned programs or indications
• Lead and develop a team of clinical operations professionals
• Ensure trials are conducted according to protocols, SOPs, GCP, departmental goals, and corporate goals
• Collaborate with the Senior Director Operational Excellence to direct CROs and other vendors
• Collaborate with Site Management & Monitoring and Site Engagement and Advocacy leadership
• Represent Clinical Operations in cross-functional governance forums and contribute to corporate SOPs and department-wide initiatives
• Own delivery of assigned clinical programs or trials, including budgets, timelines, resourcing, quality, operational strategy, clinical operations plans, and risk mitigation
• Lead and oversee execution of all trial phases in compliance with ICH/GCP, local regulations, and company procedures
• Provide senior-level oversight to cross-functional teams, CROs, vendors, investigative sites, partners, and collaborative studies
• Represent Clinical Operations during regulatory inspections
• Provide input into protocols, informed consent forms, investigator brochures, and study reports
• Ensure sponsor oversight of outsourced clinical activities and lead inspection-readiness activities
• Communicate program status, cost, risks, and issues to senior management
• Create, review, train on, and maintain departmental and organizational SOPs
• Provide managerial oversight, mentorship, performance management, talent development, and succession planning
• Drive trial and site performance and engagement; maintain relationships with investigators, site staff, collaborators, and Key Opinion Leaders
• Manage, report, and forecast program/trial budgets and align resourcing with portfolio strategy
• Maintain knowledge of the external environment and incorporate innovations such as AI/Machine Learning into trial delivery strategy
• Report directly to the Senior Vice President, Clinical Operations

• Bachelor’s degree in life science or related field; advanced degree preferred
• 12+ years of clinical operations experience in biotechnology, pharmaceutical, and/or CRO industry, including prior people leadership experience
• Phase 1-3 global trial management experience, including first-in-human studies, preferably in Oncology or complex GI malignancies and inherited genetic conditions such as Familial Adenomatous Polyposis (FAP)
• Direct experience overseeing global CROs in both fully and partially outsourced models
• Direct line management experience, including managing managers/senior individual contributors
• Proven ability to set operational strategy and guide multiple study teams to achieve program goals and timelines
• Ability to lead complex or multiple programs and exercise sound judgment and critical thinking with minimal supervision
• Strong interpersonal and communication skills, written and oral, including experience communicating with senior leadership
• Solid attention to detail and organizational skills
• Self-motivated and adaptable in a dynamic, nimble, start-up environment
• Strong sense of urgency and creative problem-solving skills
• Willingness to fill functional gaps in a small but growing organization
• Strong computer skills and experience using Microsoft Office applications, CTMS, eTMF, IRT, and EDC platforms
• Demonstrated use of AI tools in current role and responsibilities required; advanced or innovative use of AI is a strong plus
• Ability to work on-site or remotely and attend in-person meetings
• Willingness to travel up to 30%
• Previous demonstration of Health Authority interactions, interviews, and inspections

Demonstrates extensive experience in clinical operations leadership, including strategic oversight of global clinical trials and CRO management. Proficient in regulatory compliance, operational strategy, and team development within the biotechnology and pharmaceutical sectors.

• Clinical Operations Leadership
• Global Trial Management
• CRO Oversight
• Regulatory Compliance
• Operational Strategy Development

• Clinical Trial Management
• Phase 1-3 Trial Experience
• Operational Strategy Setting
• Budget Management
• Risk Mitigation

• Strong Interpersonal Skills
• Effective Communication
• Attention to Detail
• Creative Problem-Solving
• Adaptability

• Biotechnology
• Pharmaceutical
• CRO Industry
• GCP
• ICH

• Microsoft Office
• CTMS
• ETMF
• IRT
• EDC Platforms
• AI Tools