[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.ResponsibilitiesLead, coach, and mentor regional Study Start‑Up teams, ensuring continuous development, high engagement, and strong performanceEstablish clear goals, conduct performance evaluations, and build a culture of accountability and collaborationDetermine staffing strategy, overseeing resource allocation and partnering with talent acquisition to recruit top-tier clinical operations talentFoster cross-functional alignment with Clinical Development, Regulatory, Legal, Data Management, and other stakeholdersPromote a strong quality culture and operational excellence mindset across the organizationEstablish and monitor performance metrics for staff, vendors, and sites, ensuring transparency and accountabilityLead end-to-end study start-up activities: operational planning, budget inputs, regulatory/ethics submissions, CTA/contract negotiations, and site activationOversee performance metrics for SSU timelines, IRB/EC approval cycles, contract cycle times, activation rates, and readiness-to-enroll metricsIdentify operational risks, develop proactive mitigation strategies, and resolve barriers to study activation and enrollmentProvide timely operational updates to executive leadership, including dashboards, KPIs, and scenario forecastsEnsure development and delivery of critical study documents and operational plans, including protocols, ICFs, study manuals, timelines, and regulatory packagesCoordinate contract and budget negotiations for sites and vendors, ensuring execution meets program milestonesEnsure inspection readiness, oversee audit response plans, and support regulatory inspections as requiredDrive continuous improvement initiatives focused on reducing activation timelines, increasing predictability, and elevating qualityEvaluate and introduce innovative tools, technologies, and automation to streamline SSU processesChampion change management related to new systems, SOPs, and operational modelsDrive high level of ownership and accountability within team and with external stakeholdersConducts performance appraisals for direct reports which includes providing feedbackOversees training and supports set up of development plans for direct reportsContributes to the hiring of new talent into the regional GCO organizationDrive high level of ownership and accountability within team and with stakeholdersStrategic thinker with ability to translate vision into actionable executionExceptional communication, influencing, and stakeholder‑management skillsProven ability to build high‑performing teams in matrixed and fast‑paced environmentsSkilled in change leadership and fostering cross-functional collaborationSkillsBachelor's degree in a life sciences discipline required; advanced degree preferredAt least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor/biotech/CRO settingsExtensive experience as a direct line manager with responsibility for performance management and team developmentExpert 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 activationDemonstrated success managing complex clinical programs across multiple regions and phasesAdvanced risk management and problem‑solving abilitiesStrong financial acumen including budget forecasting and cost oversightAbility to work independently and manage multiple priorities effectivelyExceptional communication, influencing, and stakeholder‑management skillsProven ability to build high‑performing teams in matrixed and fast‑paced environmentsSkilled in change leadership and fostering cross-functional collaborationDrive high level of ownership and accountability within team and with external stakeholdersConducts performance appraisals for direct reports which includes providing feedbackOversees training and supports set up of development plans for direct reportsContributes to the hiring of new talent into the regional GCO organizationStrategic thinker with ability to translate vision into actionable executionMicrosoft Office Suite, Trial Management applications, analytic tools and additional relevant applications and systemsBenefitsNon-Commercial roles are eligible to participate in the annual bonus planCommercial roles are eligible to participate in an incentive compensation planAll Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awardsAll employees are eligible to voluntarily participate in the Employee Stock Purchase PlanThe Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and WellnessCompany OverviewBeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. It was founded in 2010, and is headquartered in Klein-basel, Basel-Stadt, CHE, with a workforce of 10001+ employees. Its website is https://beonemedicines.com.Company H1B SponsorshipBeOne Medicines has a track record of offering H1B sponsorships, with 3 in 2026, 20 in 2025. Please note that this does not guarantee sponsorship for this specific role.