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**General Description:** The Director, Global R&D Compliance will serve as the strategic compliance business partner and advisor to BeOne’s Global Research & Development (R&D) functions, including Global Clinical Operations, Clinical Development, and other Research functions across all therapeutic areas. Additionally, this role will support key functions with our Global Medical Affairs team. This individual will play a critical leadership role in sustaining and strengthening a culture of integrity, providing proactive guidance on current and emerging compliance risks in a rapidly evolving healthcare environment.

Acting with appropriate independence and sound judgment, the Director will oversee the Global R&D Compliance & Ethics Policy, relevant Standard Operating Procedures (SOPs), and all monitoring activities for Global R&D. This leader will collaborate closely with Legal, Compliance, HR, and R&D executives, while also working independently and communicating effectively across levels and functions.

The Director will be a key member of the Global Compliance Business Partner leadership team and will contribute meaningfully to department strategy, planning, and execution of key initiatives.

This role will report to the Head of Compliance, North America and LATAM, and Global Business Partner and be part of the Compliance Department.

This position will be in the United States, either remote or at BeOne’s offices in San Carlos, CA, Hopewell, NJ or Cambridge, MA.

Essential Functions of the Job:

+ **Compliance Business Partnership**

+ Serve as a trusted, strategic advisor to Global R&D stakeholders, providing real-time, practical compliance guidance.

+ Participate in key meetings to offer risk-based insights on clinical, scientific, and research activities including HCP and HCO communications and interactions; HCP fee for service engagements (e.g., study steering committees, advisory boards); cross border HCP engagements; external engagements (e.g., community outreach regarding clinical trials); HCP conflict of interests; and data generation initiatives.Deliver tailored compliance training and communications to ensure alignment with internal policies, industry standards, and regulatory expectations.

+ Provide compliance risk assessment, education, and oversight for Global R&D and Global Medical Affairs functions, ensuring activities comply with applicable laws, codes, and best practices.

+ Other reviews and approvals, as needed.

+ **Regulatory & Industry Standards Expertise**

+ Maintain advanced knowledge of laws, regulations, and industry codes applicable to R&D, including but not limited to:

+ U.S. Anti-Kickback Statute (AKS) and Anti-Bribery and Anti-Corruption Laws

+ False Claims Act (FCA)

+ Food, Drug & Cosmetic Act (FDCA)

+ HIPAA and HITECH

+ FDA and OHRP regulations governing clinical research (e.g., GCP)

+ ICH-GCP (International Council for Harmonisation – Good Clinical Practice)

+ EMA and global regulatory authority expectations

+ PhRMA Code, EFPIA Code, IMI, and other relevant industry standards

+ PhRMA Principles on Clinical Trials

+ International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) Principles for Responsible Data Sharing

+ Monitor emerging trends, enforcement actions, and regulatory developments to anticipate areas of evolving risk.

+ **Policy & Procedure Management**

+ Oversee the development, implementation, and maintenance of Global R&D compliance policies and related SOPs.

+ Partner with functional leaders to ensure operational understanding and adoption of policies.

+ **Training & Continuous Compliance Education**

+ Design, deliver, and evaluate engaging, role-based compliance training for R&D stakeholders.

+ Reinforce ethical decision-making and compliance obligations through ongoing education, communication, and awareness initiatives.

+ Ensure training content reflects current laws, regulations, codes, and internal processes.

+ **Monitoring & Auditing**

+ Conduct live and remote monitoring of R&D activities and provide timely feedback to stakeholders.

+ Support and coordinate back-end monitoring activities, including tracking, trending, and reporting of compliance performance metrics.

+ Partner with Global Internal Audit and Quality by preparing documentation and coordinating corrective and preventive actions.

+ Independently assess areas of potential risk and recommend actionable mitigation strategies.

+ **Ethical Interactions & Stakeholder Engagement Oversight**

+ Ensure interactions with HCPs, HCOs, study subjects, patients, caregivers, patients, community groups, and patient advocacy groups comply with BeOne policies, SOPs, and industry standards.

+ Participate in relevant meetings and activities to provide guidance and guardrails for compliant engagements.

+ Support review and evaluation of research collaborations, advisory interactions, data generation projects, and other scientific engagements.

Qualifications:

+ **Education & Experience**

+ Bachelor’s degree required; advanced degree (JD, MBA, MPH, or related scientific field) strongly preferred.

+ 10+ years of relevant compliance, legal, or R&D experience in the biopharmaceutical or life sciences industry.

+ Strong understanding of global clinical development, research operations, and global regulatory frameworks.

+ Prior experience advising Global R&D or Medical Affairs functions preferred.

+ **Skills & Competencies**

+ Demonstrated ability to serve as a strategic, solutions-oriented business partner while maintaining independence and objectivity.

+ Exceptional communication skills, with ability to influence, coach, and guide stakeholders at all levels.

+ Strong analytical, problem-solving, and risk assessment capabilities.

+ Ability to work autonomously and manage competing priorities in a dynamic environment.

+ High degree of integrity, professionalism, and sound judgment consistent with OIG and DOJ expectations for effective compliance programs.

+ **Key Leadership Attributes**

+ Collaborative team player and contributor to Compliance leadership.

+ Proactive, business-minded, and practical in approach.

+ Commitment to fostering a culture of ethics, integrity, and accountability.

+ Confidence and capability to challenge the status quo respectfully when needed.

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:

+ No

Travel:

+ Travel approximately 30%

+ Able to travel within the region or internationally as required

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.