Senior Director, Global Clinical Operations, Study Start-Up, Americas

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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Senior Director, Study Start‑Up Americas with a primary delivery responsibility for North America, will lead the strategic planning and execution of study start‑up activities across clinical programs, ensuring rapid, high‑quality site activation. This role provides leadership to cross‑functional teams, oversees budgets, engages key stakeholders, and drives continuous process improvements to enable timely and compliant trial initiation. Core responsibilities include developing and implementing activation strategies, managing regulatory and ethics submissions (IRB/EC and Health Authorities), overseeing site contract and budget negotiations, monitoring operational KPIs, and ensuring audit and inspection readiness. The role is accountable for study start-up oversight, with direct second-line manager responsibilities. Operating in an agile, fast-paced environment, the Director balances strategic leadership with hands-on execution to drive successful trial outcomes. Essential Functions of the Job: Leadership and Line Management Lead, coach, and mentor regional Study Start‑Up teams, ensuring continuous development, high engagement, and strong performance. Establish clear goals, conduct performance evaluations, and build a culture of accountability and collaboration. Determine staffing strategy, overseeing resource allocation and partnering with talent acquisition to recruit top-tier clinical operations talent. Foster cross-functional alignment with Clinical Development, Regulatory, Legal, Data Management, and other stakeholders. Promote a strong quality culture and operational excellence mindset across the organization. Establish and monitor performance metrics for staff, vendors, and sites, ensuring transparency and accountability. Study Start-Up Execution and Ownership Lead end-to-end study start-up activities: operational planning, budget inputs, regulatory/ethics submissions, CTA/contract negotiations, and site activation. Oversee performance metrics for SSU timelines, IRB/EC approval cycles, contract cycle times, activation rates, and readiness-to-enroll metrics. Identify operational risks, develop proactive mitigation strategies, and resolve barriers to study activation and enrollment. Provide timely operational updates to executive leadership, including dashboards, KPIs, and scenario forecasts Ensure development and delivery of critical study documents and operational plans, including protocols, ICFs, study manuals, timelines, and regulatory packages. Coordinate contract and budget negotiations for sites and vendors, ensuring execution meets program milestones. Ensure inspection readiness, oversee audit response plans, and support regulatory inspections as required. Process Improvement ,Innovation , and Change Leadership Drive continuous improvement initiatives focused on reducing activation timelines, increasing predictability, and elevating quality. Evaluate and introduce innovative tools, technologies, and automation to streamline SSU processes. Champion change management related to new systems, SOPs, and operational models. Other Qualifications Extensive experience as a direct line manager with responsibility for performance management and team development. Expert knowledge of global clinical trial regulations (ICH‑GCP, FDA, local regional authorities). Strong expertise in global study start‑up processes-including clinical trial package preparation, submissions, contracting, and site activation. Demonstrated success managing complex clinical programs across multiple regions and phases. [linkedin.com] Advanced risk management and problem‑solving abilities. Strong financial acumen including budget forecasting and cost oversight. Ability to work independently and manage multiple priorities effectively. Any other initiatives tasks and/or responsibilities as directed by leadership or the wider BeOne business Supervisory Responsibilities: Drive high level of ownership and accountability within team and with external stakeholders Conducts performance appraisals for direct reports which includes providing feedback Oversees training and supports set up of development plans for direct reports Contributes to the hiring of new talent into the regional GCO organization Drive high level of ownership and accountability within team and with stakeholders Strategic thinker with ability to translate vision into actionable execution. Exceptional communication, influencing, and stakeholder‑management skills. Proven ability to build high‑performing teams in matrixed and fast‑paced environments. Skilled in change leadership and fostering cross-functional collaboration. Computer Skills: Micros