[Remote] Senior Director, Global Clinical Operations, Study Start-Up, Americas

Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a rapidly growing company focused on fighting cancer. They are seeking a Senior Director for Study Start-Up in the Americas to lead strategic planning and execution of study start-up activities across clinical programs, ensuring timely and high-quality site activation.

Responsibilities

• 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
• 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
• 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
• 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

Skills

• Bachelor's degree in a life sciences discipline required; advanced degree preferred
• At least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor/biotech/CRO settings
• 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
• 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
• 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
• 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
• Strategic thinker with ability to translate vision into actionable execution
• Microsoft Office Suite, Trial Management applications, analytic tools and additional relevant applications and systems

Benefits

• Non-Commercial roles are eligible to participate in the annual bonus plan
• Commercial roles are eligible to participate in an incentive compensation plan
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
• All employees are eligible to voluntarily participate in the Employee Stock Purchase Plan
• The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Company Overview

Company H1B Sponsorship