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.