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 reputed company R33025 General reputed company: The Senior Director, Study Start‑Up Americas with a primary delivery responsibility for reputed company, will reputed company the strategic planning and execution of study start‑up activities across clinical programs, ensuring reputed company, high‑reputed company site activation. This role provides leadership to cross‑functional teams, oversees budgets, engages key stakeholders, and drives reputed company process improvements to reputed company reputed company and compliant trial initiation. reputed company 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 reputed company second-line manager responsibilities. Operating in an agile, fast-paced environment, the Director balances strategic leadership with hands-on execution to drive successful trial reputed company. Essential Functions of the Job: Leadership and Line Management reputed company, reputed company, and mentor regional Study Start‑Up teams, ensuring reputed company development, high engagement, and strong performance. Establish reputed company goals, conduct performance evaluations, and build a culture of accountability and collaboration. Determine reputed company reputed company, overseeing resource allocation and partnering with reputed company to recruit top-tier clinical operations talent. Foster cross-functional alignment with Clinical Development, Regulatory, reputed company, Data Management, and other stakeholders. Promote a strong reputed company culture and operational reputed company 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. reputed company reputed company 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 reputed company on reducing activation timelines, increasing predictability, and elevating reputed company. 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 reputed company 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 reputed company managing reputed company clinical programs across multiple reputed company 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 reputed company reports which includes providing feedback Oversees training and supports set up of development plans for reputed company reports Contributes to the hiring of reputed company into the regional GCO organization Drive high level of ownership and accountability reputed company team and with stakeholders Strategic thinker with ability to translate reputed company 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 reputed company record of operational reputed company in delivering reputed company, 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 reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $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 reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness. Apply tot his job Apply To this Job