[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, 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 that is discovering and developing innovative treatments for cancer patients worldwide. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, US, with a workforce of 10001+ employees. Its website is https://www.beonemedicines.com.
Company H1B Sponsorship
• BeOne Medicines has a track record of offering H1B sponsorships, with 20 in 2025. Please note that this does not guarantee sponsorship for this specific role.
Apply Now
Apply Now
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 that is discovering and developing innovative treatments for cancer patients worldwide. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, US, with a workforce of 10001+ employees. Its website is https://www.beonemedicines.com.
Company H1B Sponsorship
• BeOne Medicines has a track record of offering H1B sponsorships, with 20 in 2025. Please note that this does not guarantee sponsorship for this specific role.
Apply Now
Apply Now