Senior Director, Clinical Operations

WHO YOU ARE AND WHAT YOU BRING

• Bachelor’s degree in life sciences or a related field and 15+ years of clinical development experience in the biotechnology or pharmaceutical industry
• Significant experience overseeing complex global oncology clinical trials, with deep expertise in early-phase oncology development
• Demonstrated experience leading first-in-human and early-development oncology trials, including dose-escalation, backfill, expansion, signal-seeking, and dose-optimization studies
• Experience supporting development of novel oncology modalities, such as T-cell engagers, bispecific antibodies, immuno-oncology therapies, cell therapies, cytokine-based therapies, or related platforms
• Demonstrated expertise in global study start-up, country and site feasibility, investigator engagement, enrollment forecasting and optimization, and recruitment planning across academic and community oncology networks, including strategies for biomarker-selected populations, competing trials, screen failure, and complex referral pathways.
• Strong understanding of clinical trial design and execution, including operational considerations in oncology studies
• Extensive knowledge of FDA, EMA, ICH GCP, and other global regulatory requirements.
• Experience managing CROs and vendors across global clinical development programs
• Experience supporting regulatory inspections, audits, and inspection readiness activities
• Demonstrated ability to balance strategic leadership with hands-on execution, make timely decisions with incomplete or evolving data, and resolve complex operational issues in a fast-paced, resource-conscious biotechnology environment.
• Proven ability to influence cross-functional program strategy and drive timely decisions in a fast-paced biotechnology environment
• Experience contributing to departmental initiatives, process improvements, and operational excellence programs
• Ability to travel domestically and internationally as needed.

• Oversee the tactical implementation of clinical development plans for multiple global oncology trials, with accountability for delivery against timelines, budgets, quality standards, and milestones
• Provide strategic and operational leadership for first-in-human, dose-escalation, dose-optimization, backfill, combination, and expansion-cohort oncology studies, including rapid cohort activation, fit-for-purpose safety oversight, intensive pharmacokinetic and biomarker sampling, and timely delivery of data to support dose, indication, and portfolio decisions.
• Partner closely with Clinical Development, Translational Medicine, Clinical Pharmacology, Medical Monitoring, Biometrics, Regulatory Affairs, Safety, Clinical Supply, and other functions to align operational and clinical objectives and ensure consistency across assigned studies
• Translate program strategy into an integrated operational plan encompassing country and site strategy,, start-up and enrollment assumptions, patient and site engagement, vendor and CRO selection, resourcing, budget, clinical supply interfaces, data-delivery milestones, and scenario-based risk mitigation.
• Provide effective Sponsor oversight of CROs and ancillary vendors through clear governance, performance metrics, issue escalation, quality and risk review, financial oversight, and documented accountability for timely corrective and preventive actions.
• Implement and oversee risk-based quality management plans, sponsor-oversight activities, and inspection-readiness strategies across all assigned studies
• Drive Clinical Operations excellence by serving as the Clinical Operations subject matter expert for assigned clinical studies and leading cross-functional initiatives, including KPI tracking, process improvement, and oversight to ensure adherence to protocols, project plans, and GCP requirements
• Partner with senior leadership to foster a highly desirable work environment that attracts and retains high-performing Clinical Operations professionals
• Build, lead, and develop a high-performing Clinical Operations team through effective management, coaching, and professional development of direct reports
• Mentor junior Clinical Operations colleagues and contribute to building organizational capabilities that support a growing oncology portfolio
• Develop company SOPs, guidelines, and efficient systems in collaboration with the Clinical Operations team to enhance departmental effectiveness and ensure compliance with applicable FDA regulations and current ICH GCP guidelines
• Represent Clinical Operations on program, study, governance, and portfolio planning teams, providing clear operational recommendations, scenario analyses, risk assessments, and escalation of decisions required to protect program timelines and objectives.
• Serve as the operational lead for alliance and co-development programs, representing Clinical Operations in joint governance forums and facilitating cross-company operational alignment
• Lead Clinical Operations planning for emerging oncology assets transitioning from preclinical development into the clinic, including first-in-human operational strategy, country and site assessment, vendor and systems readiness, initial budget and resource assumptions, and execution planning aligned with regulatory submission and study-start milestones.