Sr Director, Clinical Operations

Position Summary Rapidly growing biotech is seeking a Senior Director, Clinical Operations to provide strategic and operational leadership across a growing clinical development portfolio. Reporting to the Chief Development Officer, this individual will serve as a key leader responsible for execution across multiple clinical programs from early development through registration, while building and leading a high-performing Clinical Operations organization. The ideal candidate is an experienced biotech clinical operations leader who has successfully managed teams, overseen global CRO partnerships, prepared programs for regulatory inspections and submissions, and advanced products from Phase I through commercialization readiness. This individual will serve as a trusted partner to executive leadership and represent Clinical Operations across cross-functional project teams and governance forums. Key Responsibilities Portfolio & Program Leadership Provide operational leadership across multiple clinical programs spanning Phase I through Phase III and registration-enabling studies.Drive development and execution of integrated clinical operational strategies.Lead planning and execution of new studies while maintaining oversight of ongoing programs.Ensure delivery of clinical milestones, timelines, budgets, and quality objectives.Identify program risks and implement mitigation strategies across the portfolio. Leadership & Team Management Lead, mentor, and develop a Clinical Operations team of approximately 10 professionals, including Clinical Program Managers, Clinical Trial Managers, and contractors.Foster a culture of accountability, collaboration, and operational excellence.Support organizational growth, workforce planning, and talent development.Build scalable processes and infrastructure to support an expanding portfolio. CRO & Vendor Management Provide executive oversight of CROs and strategic vendors.Establish governance structures, KPIs, and performance metrics.Lead vendor selection, contracting strategy, and operational oversight.Resolve escalated operational issues and ensure delivery against commitments. Cross-Functional Leadership Partner closely with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Medical Writing, Safety, Quality, and CMC.Represent Clinical Operations on project teams and leadership discussions.Drive alignment across functions to support program objectives and corporate priorities. Regulatory & Inspection Readiness Lead operational readiness activities supporting regulatory inspections and submission-related activities.Ensure programs maintain a state of inspection readiness.Support key development milestones including database lock, filing readiness, and commercialization planning.Contribute to BLA and other major regulatory submissions. Executive Partnership Serve as a key operational advisor to senior leadership.Present program updates, resource needs, risks, and strategic recommendations to executive stakeholders.Act as a trusted partner to the Chief Development Offices in managing and scaling the Clinical Operations organization. Required Qualifications Bachelor's degree in Life Sciences or related discipline; advanced degree preferred.15+ years of clinical operations experience within biotechnology, pharmaceutical, or clinical research organizations.Proven leadership experience managing Clinical Operations teams.Experience directly managing Clinical Program Managers and/or Clinical Trial Managers.Demonstrated success overseeing global CROs and strategic vendors.Significant clinical development experience spanning Phase I through Phase III.Experience supporting regulatory inspections and submission activities.Strong understanding of GCP, ICH guidelines, and global clinical trial regulations.Excellent communication, leadership, and executive presentation skills. Preferred Qualifications Experience advancing programs through BLA, NDA, MAA, or other major regulatory submissions.Prior experience taking products through approval and commercialization.Experience building or scaling Clinical Operations functions in a small biotechnology environment.Gene therapy experience preferred.Rare disease and/or ophthalmology experience a plus.Experience managing global development programs.