Executive Director, Clinical Operations

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Act as the operational deputy and strategic collaborator to the VP of Clinical Operations.

• Oversee the daily functions of the global Clinical Operations organization and serve as the primary delegate and decision-maker within defined authority matrices.

• Integrate Trial/Asset Operations, Site Operations, Biosample Operations, and Clinical Systems into a cohesive ecosystem.

• Align sub-functions with corporate development milestones and portfolio timelines.

• Maintain comprehensive visibility across the clinical portfolio and manage dependencies, critical paths, and resource constraints.

• Establish early-warning systems to identify, escalate, and mitigate execution challenges, protocol deviations, and trial bottlenecks.

• Mentor clinical operations leads and asset directors while ensuring accountability.

• Lead and develop the senior clinical operations leadership team; design succession plans and career development pathways.

• Foster a unified culture across the organizational footprints in the US and Germany.

• Drive performance calibration, talent acquisition, workforce planning, and organizational capability mapping.

• Own portfolio capacity planning, headcount forecasting, and strategic resource allocation.

• Manage budget planning, accrual tracking, and financial forecasting.

• Supervise CRO/vendor selection, performance metrics, and governance frameworks.

• Analyze and propose strategies for insourcing versus outsourcing.

• Advocate for continuous improvement, business process optimization, and scalable clinical workflows.

• Ensure compliance with ICH-GCP, FDA/EMA regulations, and global SOPs.

• Lead frameworks for inspection readiness, internal quality audits, and standardized global data protocols.

• Implement predictive operational metrics, KPIs, and executive dashboards.

• Co-design and execute the future-state operating model for late-stage development and commercialization.

• Lead enterprise-wide change management, capability integration, and digital/system advancements, including CTMS, eTMF, and decentralized trial technologies.

• Design and implement repeatable organizational systems to eliminate recurring operational friction points.

⛳️ Requirements

• A Bachelor’s degree in a scientific, nursing, or business discipline is required.

• 15+ years of clinical research experience within a biotech, pharmaceutical, or major CRO setting.

• 7+ years in a senior, multi-functional leadership role.

• An advanced degree (MD, PhD, PharmD, MS, or MBA) is preferred.

• Direct operational experience managing trials in Cell Therapy, Immuno-Oncology, or advanced therapeutic modalities is highly desirable.

• Experience in leading various aspects of clinical operations, including trial management, data/systems, sample logistics, and site monitoring.

• Extensive experience overseeing complex, global clinical trials across North America and Europe.

• Significant expertise in navigating clinical operations within Oncology is required.

• Proven track record in driving Phase III registrational trials, global regulatory submissions, and preparing operations for commercialization.

• Experience leading Clinical Operations within a biopharmaceutical organization with a strong grasp of internal clinical operations, trial execution, and regulatory requirements.

• Advanced experience managing large-scale CRO partnerships and vendor governance committees.

• Strong communication and influencing abilities.

• Applicants must be authorized to work in the United States without the need for current or future sponsorship.

• Successful completion of a background check, reference checks, and pre-employment drug screening, where permitted by applicable law.

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• PTO accrued bi-weekly, with up to 80 hours available to borrow and a maximum accrued balance of 240 hours.

• 12 company-paid holidays.

• 10 days of sick leave.

• 100% employer-paid life insurance up to 1x annual salary, with a cap of one hundred thousand dollars.

• 100% employer-paid short- and long-term disability coverage.

• 401(k) with immediate eligibility and company match.

• Partially paid parental leave for eligible employees.

• Voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, identity theft protection, and pet insurance.