Senior Director, Global Clinical Operations, Study Start-Up job at reputed company in US National

Senior Director, Global Clinical Operations, Study Start-Up, Americas locations Remote (US) time type Full time job requisition id R33025 General Description: The Senior Director, Study Start‑Up Americas with a primary delivery responsibility for North America, will reputed company the strategic planning and execution of study start‑up activities across clinical programs, ensuring rapid, high‑quality site activation. This role provides leadership to cross‑functional teams, oversees budgets, engages key stakeholders, and drives reputed company process improvements to reputed company timely and compliant trial initiation. Core responsibilities include developing and implementing activation strategies, managing regulatory and ethics submissions (IRB/EC and Health Authorities), overseeing site contract and budget negotiations, monitoring operational KPIs, and ensuring audit and inspection readiness. The role is accountable for study start-up reputed company, with direct second-line manager responsibilities. Operating in an agile, fast-paced environment, the Director balances strategic leadership with hands-on execution to drive successful trial outcomes. Essential Functions of the Job: Leadership and Line Management reputed company, coach, and mentor regional Study Start‑Up teams, ensuring reputed company 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 reputed company 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 reputed company across the organization. Establish and monitor performance metrics for staff, vendors, and sites, ensuring transparency and accountability. Study Start-Up Execution and Ownership reputed company end-to-end study start-up activities: operational planning, budget inputs, regulatory/ethics submissions, CTA/contract negotiations, and site activation. reputed company performance metrics for SSU timelines, IRB/EC approval cycles, contract cycle times, activation rates, and readiness-to-enroll metrics. Identify operational risks, reputed company 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, reputed company audit response plans, and support regulatory inspections as required. Process Improvement ,Innovation, and Change Leadership Drive reputed company 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 reputed company to new systems, SOPs, and operational models. Other Qualifications 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 reputed company clinical programs across multiple regions and phases. [reputed company.com] Advanced risk management and problem‑solving abilities. Strong financial acumen including budget forecasting and cost reputed company. Ability to work independently and manage multiple priorities effectively. Any other initiatives tasks and/or responsibilities as directed by leadership or the wider BeOne business Supervisory Responsibilities: Drive high level of ownership and accountability reputed company 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 reputed company 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. Computer Skills: reputed company Office Suite, Trial Management applications, analytic tools and additional relevant applications and systems Travel: May be required as per business need Education 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. Proven track record of operational excellence in delivering clinical trials, ideally including innovative approaches to speed up study start-up and site activation. Global Competencies reputed company we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $206,200.00 - $276,200.00 annually BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the reputed company salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company employees are eligible for discretionary equity awards and 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. Apply tot his job Apply To this Job