BeOne Medicines · 1 day ago
Director, Global R&D Compliance
United States
Full-time
Remote
Director/Executive
$193K/yr - $253K/yr
10+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer and is seeking a Director of Global R&D Compliance. This role will serve as a strategic compliance business partner, overseeing compliance policies and providing guidance on compliance risks within the Global Research & Development functions.
Pharmaceuticals
Responsibilities
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
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
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
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
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
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
Qualification
Required
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
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
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
Proficiency in the Microsoft suite of tools including Outlook, Word, PowerPoint and Excel
Preferred
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
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