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, and they are seeking a Senior Director for Global Clinical Operations, Study Start-Up in the Americas. This role will lead strategic planning and execution of study start-up activities, ensuring effective site activation and overseeing cross-functional teams, budgets, and compliance with regulatory requirements. 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 • Microsoft Office Suite, Trial Management applications, analytic tools and additional relevant applications and systems Benefits • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness Company Overview • BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, US, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship • BeOne Medicines has a track record of offering H1B sponsorships, with 20 in 2025. Please note that this does not
