Regional Clinical Compliance Director/Senior Director

Regional Clinical Compliance Director/Senior Director Apply for the Regional Clinical Compliance Director/Senior Director role at BeOne Medicines. General Description The Regional Clinical Compliance (RCC) Director/Senior Director leads the implementation of Global Clinical Compliance and Inspection Management strategy across BeOne Medicines clinical activities at global, regional, country, site and/or study levels. In Summary Provides compliance oversight and quality support to BeOne GCO study teams, ensuring that GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained. Seeks opportunities to implement best practices, share lessons learned, and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team and Clinical Operations. Supports timely identification of non‑compliance issues and quality events, ensuring appropriate escalation to relevant stakeholders. Tracks and trends non‑compliance issues, quality events, and observations identified during Site Compliance Visits to help identify issues and risks across BeOne study programs and processes. Adheres to ICH/GCP, local regulations, applicable BeOne SOPs and contributes to the development and review of Clinical Operations Work Instructions and SOPs. Demonstrates significant clinical study experience and understanding of investigational site setup, trial management, trial conduct at study & site level, and clinical operations processes. Demonstrates leadership competencies, project management and organizational skills. Supports inspection readiness, preparation, hosting, response management, and further lesson‑learn development. Essential Functions Provides team leadership, guidance, oversight, and GCP expertise to Regional Clinical Compliance stakeholders. Fosters a collaborative relationship with key stakeholders to enable timely identification of potential problems and to ensure proper root‑cause assessments and corrective actions. Supports the Regional Clinical Compliance team through guidance in drafting responses and corrective action plans for audits and inspections. Identify potential compliance matters and drive development of improvement methods and resolutions. Ensures appropriate escalation of GCP non‑compliance issues, quality events, potential misconduct, and significant deviations to relevant GCO stakeholders. Develops and implements satisfactory CAPA to address GCP non‑compliance issues within timelines defined in relevant BeOne SOP. Prepares, hosts and manages Site & Sponsor inspections as applicable. Develops GCP inspection readiness programs at study, country, regional and/or global level, as assigned. Feeds audit/inspection findings into the GCP inspection readiness program and process improvement initiatives. Approves On‑Site Compliance Visit (SCV) and Remote Compliance Review scheduling and preparation for assigned studies. Peer‑review compliance assessment reports for SCV and Remote Compliance Review. Leads RCC management in monitoring Key Compliance Indicators (KCI) and develops metrics accordingly. Conducts trend analysis to identify potential compliance risks associated with study delivery and shares outcomes with Regional Clinical Operation and Global Clinical Compliance teams. Establishes preventive action initiatives to mitigate risks proactively. Leads development and implementation of internal GCP compliance process improvement strategies, tools and initiatives. Provides expertise and guidance on initiatives involving processes and systems intended for use in clinical trials to ensure compliance with ICH GCP and local regulations. Provides feedback on investigator site performance for future study feasibility. Stays abreast of new and revised government, industry, and company regulations, trends and interpretations by participating in trainings, conferences, workshops, and discussion groups. Core Competencies, Knowledge and Skill Requirements Expert knowledge of ICH/GCP, regional regulations, SOPs and Clinical Operations Work Instructions. High level of clinical operations knowledge. Strong analytical and managerial skills. Ensures appropriate escalation of quality issues, potential misconduct, and significant deviations to relevant stakeholders. Communication & Interpersonal Skills Excellent English written and verbal communication and interpersonal skills. Excellent organizational, presentation and training skills with an ability to prioritize and multi‑task. Ability to work independently in a multicultural setting and effectively handle multiple priorities in a fast‑paced environment. Supervisory Responsibilities Oversees the work of direct/indirect reports to ensure on‑time, on‑target and within‑budget results. Conducts regular 1:1 meetings and staff meetings, including performance appraisals and development planning. Mentors Clinical Compliance team members, delegating responsibilities and providing support. Provides constructive feedback to Clinical Operations line managers to support performance reviews. Education and Experience Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline with a minimum of 14 years of progressive experience in clinical operations roles. Minimum 14 years of experience in a GCP compliance or equivalent role. Experience in oncology global trials preferred. Exceptions may be made for candidates with equivalent appropriate Clinical Operations experience. Computer Skills and Travel PC literacy required; MS Office (Outlook, Word, Excel, PowerPoint). Up to 10‑15% travel. Global Competencies Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self‑Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results‑Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal‑opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. #J-18808-Ljbffr