BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Regional Clinical Compliance (RCC) Senior Director is responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne Medicines Clinical activities at global, regional, country, site and/or study levels as applicable.
In summary:
- Provides compliance oversight as well as quality support to BeOne GCO study teams, for their assigned studies and ensures that appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained.
- Seeks opportunities to implement best practices, share lessons learned, lead and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team.
- Supports timely identification of non-compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.
- Tracks and trends non-compliance issues, quality events, and any other relevant observations identified during Site Compliance Visits, to help identify issues and risks across BeOne study programs and processes. The job holder supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs.
- Adheres to ICH/GCP, local regulations, applicable BeOne SOPs and contributes to the development and/or 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, as well as clinical operations processes.
- Demonstrates BeOne clinical operations knowledge, organizational skills, project management and leadership competencies.
- Supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as applicable.
Essential Functions:
- Provides team leadership, including guidance, oversight and GCP expertise to Regional Clinical Compliance stakeholders.
- Fosters a collaborative working relationship with key stakeholders (e.g. regional and country study team members, global & regional clinical compliance, GCOE and GCO team members), to enable timely identification of potential problems, to ensure proper root cause assessments and corrective and preventative actions are in place.
- Supports Regional Clinical Compliance team through guidance in drafting responses and corrective and preventative action plans to internal/external audits and external inspections as required.
- Identifies potential compliance matters and drives development and implementation of methods for improvement and resolution.
- Responsible to provide GCP compliance guidance and support to BeOne CST and other GCO stakeholders across portfolio of studies in the applicable country / region, ensuring that appropriate GCO study conduct, inspection readiness and overall compliance to applicable regulatory requirements is maintained.
- Ensures appropriate escalation of GCP non-compliance issue and / or quality events, potential misconduct, and significant deviations to relevant GCO stakeholders.
- Ensures development and implementation of satisfactory CAPA addressing GCP non-compliance issue / quality event within timelines defined in relevant BeOne SOP.
- Ensures preparation, hosting and management of Site & Sponsor inspections, as applicable.
- Ensures development and implementation of satisfactory CAPA addressing site inspection findings as applicable.
- Ensures the development of GCP inspection readiness programs at study, country, regional and/or global level, as assigned.
- Ensures GCP related events; audit/inspection findings are fed back into the GCP inspection readiness program, as well as process improvement and/or use for relevant training material.
- Approve On-Site Compliance Visit (SCV) and Remote Compliance Review scheduling and preparation for assigned studies, as relevant.
- Peer review Compliance Assessment reports (e.g. Site Compliance Visit (SCV) and Remote Compliance Review), as relevant.
- Lead RCC management in monitoring Key Compliance Indicators (KCI) and developing metrics accordingly.
- Conducts trend analysis to identify potential compliance risks associated with study delivery and opportunities for compliance optimization and share outcomes with Regional Clinical Operation and Global Clinical Compliance team as required.
- Establishes preventive action-related initiatives to mitigate risks proactively.
- Drive the development and implementation of internal GCP compliance process improvement strategies, tools, initiatives, or workstreams.
- Lead development of GCP Compliance and inspection readiness management program and associated training material.
- Provides expertise and guidance on initiatives involving processes and systems intended for use in clinical trials to ensure compliance with ICH GCP and any local regulations.
- Provide feedback on investigator site performance for future study feasibility purposes.
- Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate.
Core Competencies, Knowledge and Skill Requirements:
- Serves as a GCP expert to the Clinical Operations EMEA with excellent working knowledge of ICH/GCP, regional regulations, SOPs and Clinical Operations Work Instructions.
- Demonstrates a 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 skills, presentation skills and training skills, with an ability to prioritize and multi-task.
- Ability to work independently in multi-cultural 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.
- Conduct regular 1:1 meetings and any other staff meetings including mid-year and year end performance appraisals for direct reports which includes providing constructive feedback. Engages in career development planning for direct reports.
- Mentors Clinical Compliance team members by delegating responsibilities, overseeing and providing support with assigned tasks, in line with their development plans.
- Provides constructive feedback on Clinical Operations team members to their line managers to support performance review.
Education Required:
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 12 years of progressive experience in clinical operations roles.
- Minimum 12 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
- Experience in oncology global trials is preferred.
*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.
Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Travel: up to 10-15% travel
Global Competencies
When 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 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.