BeOne Medicines · 3 days ago
Director, Global Clinical Operations, Compliance
United States
Full-time
Remote
Director/Executive
$176K/yr - $236K/yr
7+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer. The Director of Global Clinical Operations, Compliance is responsible for managing compliance-related needs, providing guidance to stakeholders, and implementing strategies to enhance successful clinical trial conduct.
Pharmaceuticals
Responsibilities
Identifies and anticipates potential issues impacting the ability to meet business goals; develops and implements methods of improvement and resolution
Independently leads and/or participates in global and cross-functional initiatives, working groups and project teams as a decision maker, subject matter expert or reviewer of initiatives and solutions to ensure compliance with ICH GCP, applicable laws and regulations and consistency within BeiGene Quality Management System
Works collaboratively with global and regional study teams to ensure that proper root cause assessments, corrective and preventive actions for quality issues, site non-compliance, audit and inspection findings are in place, and that lessons learnt are disseminated and actioned upon within the broader GCO organization. Identifies and escalates significant compliance issues within GCO and to relevant leadership, including assessment of serious breaches
Contributes to the design and implementation of risk identification and management strategies for clinical studies and other regulated drug development activities. Works collaboratively with internal and external business partners and key stakeholders to provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical study conduct and other regulated drug development activities to ensure compliance with ICH GCP, applicable laws and regulations and BeiGene policies and procedures
Maintains the highest level of expertise in global GCP guidance and regulations, industry best practices, and internal policies and procedures impacting drug development to promote quality and compliance within GCO. Embeds quality principles throughout the organization
Supports quality issue trending, analysis, and review activities to proactively identify broader issues and/or patterns within the GCO organization; leads the design and implementation of corrective and/or preventive actions, as applicable; escalates the identified issues with broader organizational impact within GCO and to relevant leadership
Ensures provision of actionable data and insights regarding the state of quality and compliance to GCO leadership and other stakeholders as requested i.e., GCOE
Reports compliance state of the organization by working together with critical functions in GCOE, such as Learning & Development, TMF, process management, and Global Program Compliance
Identifies potential compliance matters and drives the development and implementation of methods for improvement and resolution pragmatically and effectively
Proactively researches, evaluates, and makes recommendations associated with organizational impact of evolving laws and regulations. Benchmarks and stays abreast of other industry and marketplace developments and best practices as they relate to drug development quality and compliance
Leads inspection preparation and management for local country and global Health Authority inspections
Provides leadership (direction, oversight, guidance and subject matter expertise) to project teams as assigned
Oversees the work of indirect/direct reports, as assigned, to ensure on-time, on-target and within budget results. Provide ongoing mentoring, coaching, guidance and feedback to ensure indirect/direct reports are successful in their work, as well as have the necessary and timely access to information and other resources. Supports the professional development of direct/indirect reports, as applicable
Conducts regular one-on-one and any other staff meetings to ensure timely communication with indirect/direct reports. Provides feedback on formal performance reviews and career development planning for all indirect reports
Manages budget for assigned projects and/or activities. Maintains operational and budgetary awareness of the overall GCO Compliance project portfolio, as applicable
Qualification
Required
Bachelor's degree in Life Sciences, Medicine, Quality Management, or related field and at least 10 years of relevant experience; or Master's degree in Life Sciences, Medicine, Quality Management, or related field and at least 7 years of relevant experience
Relevant experience can be in drug development, clinical operations, clinical quality assurance, medical affairs, clinical regulatory compliance or a related field
Has impeccable ethics. Exercises sound judgement and discretion in matters of significance
Demonstrated experience with planning, prioritizing, and managing high-level initiatives and projects
Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity
Knowledgeable in stakeholder management and influencing change
Proven interpersonal skills, customer-focused approach, and effective teamwork and collaboration skills
Must demonstrate knowledge of and strong aptitude to learn about the evolving legal and regulatory environment, ICH GCP, applicable laws, regulations, and industry standards as it relates to a global pharmaceutical organization
Must understand corporate (local and global) and organization (local and global) policies, procedures and guidelines
Excellent organizational and planning skills; able to prioritize, identify conflicts and meet deadlines without direction
Strong verbal and written communication skills
Highly adept at synthesizing and summarizing unusually complex and/or voluminous content in clear, concise, and actionable communications
Proven ability to lead the analysis and simplification of complex systems or processes into pragmatic solutions
Strong ability to analyze and simplify complex systems
Highly effective in analytical and strategic assessment of GCP compliance risks; able to articulate potential business impact
Demonstrated ability to influence and lead both with and without authority in a matrix organization, leading innovation and change
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