Director, Healthcare Compliance, Germany, UK & Ireland

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:

BeOne is seeking an experienced and strategic Director, Healthcare Compliance, Germany, UK & Ireland to lead and advance BeOne’s Healthcare Compliance program across these key markets. The role will serve as a senior strategic partner to the business and leadership teams, providing independent, pragmatic and risk-based advice to support responsible business growth and ensure that BeOne’s activities are conducted in accordance with applicable laws, regulations, industry codes, BeOne’s Code of Conduct and Healthcare Compliance policies, as well as relevant industry standards and best practices.

As BeOne continues to expand its global presence and evolve its commercial, medical and clinical activities, this position will have accountability for the strategic direction, implementation, oversight and continuous enhancement of the Healthcare Compliance framework across Germany, the UK and Ireland. The Director will work closely with local, regional and global stakeholders to ensure that the compliance program remains proportionate, effective and aligned with the organization’s evolving business model and risk profile.

The Director will act as a trusted senior advisor to leadership, providing expert compliance counsel on strategic initiatives and complex business activities and helping the organization anticipate, assess and appropriately manage compliance risks. The role will work closely with Commercial, Medical, Market Access, Regulatory, Clinical, Pharmaceutical Affairs, Corporate Affairs, Legal, Finance, Procurement and other functions on a broad range of healthcare compliance matters.

The successful candidate will be a highly credible and influential compliance leader who is comfortable operating in a dynamic and evolving environment, able to navigate complexity and ambiguity, exercise sound judgment and balance robust compliance standards with pragmatic and commercially informed solutions.

Experience in the pharmaceutical or biotechnology industry is strongly desirable. Comprehensive experience in healthcare compliance within another heavily regulated industry and/or relevant consulting experience supporting pharmaceutical or biotechnology organizations may also be considered.

The Director will serve as a senior compliance leader across Germany, the UK and Ireland, participate in relevant local leadership and governance forums, and work closely with the European and Global Compliance organizations. The role will also contribute to the continued evolution and strengthening of BeOne’s broader global Healthcare Compliance program, bringing regional insights, leading practices and emerging risk considerations into global initiatives.

This position is part of the senior management in Germany, UK & Ireland and will be located in Germany (Hybrid) with at least 25-30 % travel to UK & I.

Key Responsibilities:

• Single point of Compliance and Risk Managament for Germany, UK & Ireland with the responsibility of leading and owning the Healthcare Compliance strategy for Germany, UK & Ireland, establishing a risk-based framework aligned with applicable local laws, regulations and industry codes, BeOne’s Code of Conduct, global Healthcare Compliance policies and relevant industry standards and best practices.

• Serve as a senior strategic compliance advisor to local and regional leadership, providing independent advice and constructive challenge on significant compliance risks, strategic business initiatives, new operating models and evolving regulatory expectations.

• Act as the senior point of contact for Healthcare Compliance across Germany, UK & Ireland, establishing clear accountability and governance for compliance matters and ensuring appropriate escalation and resolution of material risks.

• Shape and continuously enhance the Healthcare Compliance Program across the three markets, ensuring that policies, procedures, controls and governance mechanisms remain effective, proportionate and aligned with BeOne’s evolving business activities and risk profile.

• Partner closely with senior stakeholders across Commercial, Medical, Market Access, Regulatory, Clinical, Pharmaceutical Affairs, Corporate Affairs, Legal, Finance, Procurement and other functions to provide timely, practical and risk-based compliance advice on business activities and strategic initiatives.

• Provide expert compliance advice on activities involving healthcare professionals, healthcare organizations, patients, government entities and other external stakeholders, including events, engagements, consultancy arrangements, sponsorships, grants, educational activities and other interactions presenting healthcare compliance risk.

• Lead the compliance risk management framework across Germany, UK & Ireland, including the annual compliance risk assessment, identification of emerging risks, prioritization of mitigation activities and development of a risk-based monitoring and assurance plan.

• Provide strategic oversight of the implementation of ABAC controls and other relevant compliance controls, including risk-based third-party due diligence and controls relating to interactions with HCPs, HCOs, government entities and other external stakeholders.

• Provide oversight of high-risk activities and arrangements, including consulting agreements, sponsorships, grants, donations, educational activities and other engagements, ensuring appropriate controls, approvals, documentation and escalation mechanisms are in place.

• Oversee applicable regulatory, industry code, transparency and other mandatory submissions and disclosures across Germany, the UK and Ireland, working with relevant internal and external stakeholders to ensure requirements are met accurately and within applicable timelines.

• Oversee the compliance monitoring and assurance framework, including risk-based reviews, monitoring, testing and audits. Identify systemic or emerging compliance risks and ensure that appropriate remediation and corrective action plans are developed, implemented and tracked to completion in partnership with the Global Compliance teams.

• Lead/Partner on the compliance response to significant issues, investigations and potential violations, partnering with Legal, HR, Internal Audit, Security and other relevant stakeholders as appropriate. Oversee remediation activities and ensure lessons learned are incorporated into the compliance program.

• Partner closely with the European and Global Compliance teams to implement global and regional compliance programs while ensuring that local market requirements, risks and business realities are appropriately incorporated.

• Regularly educate and inform the local leadership and team on matters related to the compliance program as well as relevant healthcare industry legal and compliance developments

• Represent the function when needed in any committee or other leadership platform

• Partner with internal stakeholders (local LT and all key functions) and external (e.g., outside counsel, local Competent authorities, investigators) stakeholders for the conduct and resolution of potential compliance investigations/observations, including the management of any resulting corrective actions plans; support coordination of any speak up, engagement, and other whistleblowing mechanisms and ensure alignment with all applicable laws

• Provide and maintain effective compliance communications with business partners to promote compliance awareness

• Support global and regional compliance projects on an as-needed basis, including support of commercial, medical, market access and clinical teams and activities

• Any other requirements that may be identified by Management.

Education Required:

Bachelor's of Law, Bachelor of Arts or Bachelor of Science required and 10+ years of experience.

LLM, MBA or other advanced degree would be a plus.

Supervisory Responsibilities:

To be decided. This is a matrix set up so the individual should be fluent in ability to navigate matrix reporting and management. This means that this individual also manages liaisons and relationships autonomously and or under direction from the Management.

Travel:

Approximately 35%.

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.