Senior Director, Global Clinical Operations

Overview

The Senior Director, Global Clinical Operations role provides global strategic and operational leadership for the planning, execution, and oversight of clinical studies supporting regulatory submissions, market access, and post-market evidence requirements. This role leads a high-performing global clinical operations organization, ensuring compliant, efficient, and high-quality delivery of the company's clinical evidence portfolio.

Responsibilities

Strategic and Functional Leadership•Define and lead the clinical operations strategy, ensuring alignment with company priorities.•Oversee operational planning and execution across the global clinical study portfolio, including feasibility, pre-market, pivotal, and post-market/PMCF studies.•Establish and manage global operational governance, performance metrics, and risk-management frameworks.•Partner with Clinical Affairs, Regulatory Affairs, Quality, R&D, and other stakeholders to shape evidence-generation strategies and ensure operational readiness.

Global Study Execution and Oversight•Provide executive oversight of end-to-end study delivery, ensuring adherence to timelines, budgets, enrollment targets, and quality standards.•Ensure studies comply with ISO 14155, ICH GCP, EU MDR, FDA regulations, and other applicable global requirements.•Lead operational risk assessment, mitigation planning, and escalation management across programs.•Oversee global site strategy, including site identification, qualification, activation, and performance management.

Supplier Governance•Guide supplier strategy, including selection, contracting, and ongoing governance of clinical service providers.•Establish performance expectations, KPIs, and quality oversight mechanisms to ensure delivery excellence.•Drive issue resolution, quality oversight, and continuous improvement across outsourced activities.

Quality, Compliance, and Inspection Readiness•Ensure global inspection readiness for all clinical studies and operational processes.•Partner with Quality Assurance to support audits, regulatory inspections, and development of CAPAs.•Champion operational excellence through procedure development, process optimization, and implementation of best practices.Leadership and Talent Development•Lead, mentor, and develop a global team of clinical professionals, including managers, team leads, and support staff.•Build organizational capability through training, coaching, and succession planning.•Foster a culture of accountability, collaboration, and continuous improvement.•Partner with HR to recruit, onboard, and retain top clinical operations talent.

Cross-Functional and Executive Communication•Provide clear, timely communication to executive leadership on study progress, risks, budgets, and strategic considerations.•Represent Clinical Operations in portfolio reviews, strategic planning meetings, and cross functional leadership meetings.•Build strong, trusted relationships with internal and external stakeholders to ensure alignment and operational success.

Qualifications

• Bachelor's degree in scientific, medical, or engineering discipline, or prior substantial experience in the design and management of clinical studies, in the medical device industry, preferred.•Minimum 10 years of prior relevant experience.
• Extensive experience in the conduct and management of clinical studies, including pre-market, pivotal, and post-market/PMCF studies.•In-depth knowledge of regulatory authorities and requirements impacting global clinical studies (FDA, EU MDR, ISO 14155, ICH GCP, and other relevant standards.•Understanding of quality management systems and inspection readiness in a regulated environment.•Familiar with supplier governance and clinical service provider management.•Strong analytical and strategic thinking skills; ability to interpret complex data and develop actionable strategies.•Strong verbal and written communication skills•Experience in writing technical documents and presenting to executive leadership and regulatory bodies.•Ability to manage multiple projects and responsibilities simultaneously.•Change management and process optimization skills.•This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers.