Executive Director, Clinical Operations

The Executive Director of Clinical Operations will provide global operational leadership overseeing complex clinical programs focusing on innovative T-cell engager therapies for immunology and oncology indications. This role is responsible for efficient planning, resourcing and execution of portfolio level programs in adherence to ICH-GCP, FDA regulations, and company SOPs. The Executive Director will report into the Head of Project Team Leads and will ensure strategic alignment of programs and key stakeholder management in a fast-paced environment, while mentoring and growing a Clinical Operations team and culture to ensure successful program delivery.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Drive global clinical operations strategy and execution for programs ensuring all clinical activities support IND-enabling through Phase 3 objectives, as well as future clinical development plans.
• Collaborate effectively cross-functionally with senior leadership to ensure operational initiatives support strategic company goals.
• Establish and refine scalable best practices to drive efficiency while preparing for future departmental growth.
• Oversee the development, review, and operational implementation of study documents, including protocols, informed consent forms, CRFs, monitoring plans, and pharmacy manuals ensuring consistency among programs.
• Partner closely with executive leadership to shape clinical development strategy, operational plans, budget forecasts, and long-range portfolio planning across multiple programs.
• Lead executive-level discussions regarding program risks, mitigation strategies, timelines, and resource allocation, ensuring alignment with corporate objectives and investor-facing milestones.
• Serve as the Clinical Operations representative to Executive Leadership and governance committees, providing strategic recommendations, portfolio risk assessments, resource forecasts, and operational updates to support key business decisions.
• Influence organizational strategy through the development of clinical operations capabilities, infrastructure, processes, and talent necessary to support portfolio growth.
• Mentor and support direct reports, fostering professional development, team performance and a strong culture.
• Oversee site strategy and establish Clinical Operations team relationships with investigators and key opinion leaders.
• Ensure successful external partner relationships with CROs, central labs, patient advocacy groups and others. Ensure deliverables are met on time, within budget, and to quality standards.
• Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance.
• Develop and implement operational plans, timelines, and budgets for clinical programs.
• Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• Bachelor’s degree in life sciences or related discipline with 15+ years of progressive clinical development and operations experience, including significant leadership responsibility within biotechnology or pharmaceutical organizations; advanced degree preferred.
• Strong experience in complex autoimmune indications, early phase experience strongly preferred.
• Ability to define strategy and ensure organizational goals are executed in global clinical operations plans.
• Exceptional executive presence and communication skills with demonstrated success presenting complex clinical, operational, and business information to Executive Leadership Teams, governance committees, and external stakeholders.
• Experience leading cross-functional teams in a matrix environment and driving alignment across Clinical Development, Medical, Regulatory, Biometrics, Translational Sciences, Safety, and Program Management.
• Proven track record of leading complex clinical programs from start to completion.
• Strong knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.
• Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).
• Expertise in clinical budgeting and efficient allocation of resources
• Demonstrated success in leading, mentoring, developing diverse clinical teams and providing oversight to CROs.
• Exceptional executive presence and communication skills with demonstrated success presenting complex clinical, operational, and business information to Executive Leadership Teams, governance committees, and external stakeholders.
• Strong organizational and time management abilities.
• High level of accountability, adaptability, and attention to detail with an ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.