BeOne Medicines · 3 hours ago
Senior Director, Global Clinical Operations, Study Start-Up, Americas
United States
Full-time
Remote
Director/Executive
$206K/yr - $276K/yr
12+ years expBeOne 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.
Pharmaceuticals
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
Qualification
Required
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
BeOne Medicines
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.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase