General Description:BeiGene is actively seeking a seasoned compliance leader at the Director level who thrives in fast-paced settings, brings a proactive, pragmatic approach to risk management, and is driven to make an impact. This new role will report to the Head of Compliance, North America and New Markets, and will play a critical role in enhancing BeiGene’s Compliance program across North America, supporting both U.S. and Canadian operations.We are looking for someone who can seamlessly partner with business teams to nurture our culture of integrity and compliance, ensuring we meet both regulatory and ethical standards while fostering practical, actionable solutions. In this role, you will engage closely with key stakeholders and various business lines, driving initiatives that align compliance with broader business objectives to support BeiGene’s ongoing growth and commitment to ethical practices.This position will be in the United States, either remote or at BeiGene’s offices in Emeryville, CA, San Mateo, CA, or Cambridge, MA.Essential Functions of the job:
Key Compliance Leadership : Serve as the primary compliance contact for the U.S. and Canadian markets, providing proactive, solutions-oriented support to Commercial, Market Access, Medical Affairs, Clinical, and R&D teams. Actively participate in their critical business activities, offering insights that align with BeiGene’s goals.
Strategic Compliance Development : Shape a forward-looking compliance strategy that aligns with company goals and adapts to regulatory shifts, industry trends, and internal dynamics. Gather input from stakeholders, assess risks, and set targeted priorities to support a proactive ethics and compliance environment.
Performance and Progress Metrics : Establish clear, measurable performance metrics for compliance activities, tracking and adjusting as needed to ensure strategic goals are met efficiently and effectively.
Risk-Based Approach and Advisory : Lead a risk-based methodology for activity reviews, offering expert compliance insights and consulting relevant stakeholders or subject matter experts as necessary.
Training and Communication Development : Design and implement both formal and informal training programs, along with other internal communication efforts, to address compliance risks, reinforce program messages, and build a culture centered on ethics and integrity.
Committee Participation : Actively participate in both standing and ad hoc committees, contributing compliance expertise and insights to cross-functional initiatives.
Trends and Process Adaptation : Partner with business stakeholders to anticipate and address emerging compliance trends, adjusting processes as needed to maintain compliance integrity within a dynamic environment. Stay current on ethics and compliance developments, adapting BeiGene’s practices to align with new regulatory requirements and industry standards.
Compliance Guidance and Business-Focused Solutions : Provide actionable, business-oriented compliance solutions that align with an evolving legal landscape, supporting BeiGene’s commitment to ethical operations.
Live and Remote Monitoring : Lead live compliance monitoring efforts and support ongoing back-end monitoring activities, including measurement, tracking, and reporting on compliance performance.
Audit Support and Corrective Action Guidance : Guide and support compliance audits, working collaboratively with stakeholders to ensure that any required corrective actions are implemented promptly and effectively.
Data-Driven Insights : Use monitoring and audit data to identify and present trends to leadership, offering coaching, recommendations, and corrective actions to address compliance challenges.
Policy Oversight and Resource Management : Oversee internal compliance policies, procedures, and communication channels, managing resources like the ethics hotline and intranet compliance content to ensure accessibility and transparency.
Organizational Compliance Culture : Drive efforts to build and communicate a robust compliance culture across the organization, emphasizing integrity and ethical behavior as core values.
Responsive Stakeholder Communication : Maintain open, transparent communication channels, promptly responding to stakeholder inquiries and offering timely, constructive feedback.
Continuous Improvement and Feedback Integration : Pursue continuous improvement by actively seeking stakeholder feedback, continuously enhancing the quality, effectiveness, and impact of compliance support.
Required Qualifications:
Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required.
Minimum of ten years of combined experience in healthcare compliance, including in-house experience.
Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products.
Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA).
Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings.
Ability to maintain a high degree of confidentiality in dealing with sensitive matters.
Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner.
Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization.
Strong analytical and problem-solving skills.
Strong attention to detail and accuracy.
Strong collaborative, interpersonal and oral communication skills.
Preferred Qualifications:
Ability to work effectively in a global environment and good at managing work under a matrix organization structure and comparably complicated environment.
Management experience and ability to mentor and supervise a team of professionals.
Computer Skills:
Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel
Supervisory Responsibilities:
N/A
Travel:
Travel approximately 20%
Able to travel within the region or internationally as required
BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.