Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Global Compliance Officer based in Somerset, NJ. 

Role Overview

The Global Compliance Officer is responsible for leading the global compliance function in a rapidly growing and evolving biotechnology company that is focused on successful transition to commercial operations globally. They will develop, execute, and oversee the company’s compliance program on a global scale to prevent illegal, unethical, or improper conduct, in line with current industry best practices and government guidance. The Global Chief Compliance Officer will serve as a strategic advisor to the CEO, other members of senior management and the board of directors, ensuring adherence to all relevant laws, regulations, and industry standards. They will foster a culture of compliance that facilitates the company’s effective operation while meeting government compliance standards. This role requires exceptional leadership, communication, and problem-solving skills, as well as a deep understanding of biopharmaceutical compliance and legal frameworks.

Key Responsibilities  

• Provide leadership to develop, implement and maintain an effective integrated global ethics and compliance program for a rapidly growing biopharmaceutical company with global R&D, manufacturing, and commercial operations. Oversee the development of programs to prevent and detect violations of laws, company policies, and other misconduct; promote ethical practices; and ensure the implementation of the compliance program throughout the organization.
• Lead a global team of Compliance professionals in various geographic markets to ensure effective governance and oversight of compliance-related matters in relevant jurisdictions.
• Provide strategic guidance to the CEO, other members of senior management and the board of directors on global biopharmaceutical compliance-related matters, including enterprise-wide risk assessments to evaluate external and internal compliance risk factors impacting a global biopharma business.
• Establish and maintain relationships with regulatory authorities and industry organizations in various jurisdictions to stay abreast of changes in applicable laws and regulations affecting the biopharma industry.
• Develop strategies for global compliance training programs for employees at all levels of the organization, ensuring awareness of legal and ethical obligations.
• Coordinate audits and assessments to evaluate the effectiveness of the compliance program and identify areas for improvement.
• Oversee investigations of allegations of misconduct or violations of company policies, and recommend appropriate corrective actions.
• Collaborate with global cross-functional teams, including legal, regulatory affairs, and quality assurance, to ensure a coordinated approach to compliance initiatives. Identify and address their specific compliance needs, interests, and requirements through effective communication and collaboration.
• Develop and periodically review and update the Company’s Code of Conduct to reflect evolving regulatory requirements and industry best practices. Serve as a champion for ethical behavior and integrity throughout the organization, promoting a culture of compliance and transparency.
• Prepare and present reports on compliance activities, trends, and metrics to senior management and the board of directors.
• Stay informed about emerging compliance issues and trends in the pharmaceutical industry, and proactively address potential risks or challenges.

Requirements

• A Bachelor’s Degree from an accredited university.
• A Juris Doctor with active membership in a Bar Association highly preferred.
• Minimum 15 years of relevant compliance or legal experience within the pharmaceutical or healthcare industry with expert knowledge of healthcare and anti-corruption laws, and with experience building and operating global compliance programs and, preferably, leading global teams.
• In-depth knowledge of relevant laws, regulations, and industry guidance regarding relating to global biopharmaceutical compliance programs, including government price reporting laws, privacy laws, fraud and abuse and anti-kickback statutes, industry codes in relevant markets including PhRMA code, EFPIA and JPMA, , transparency reporting requirements in various jurisdictions, and anti-bribery laws.
• Proven track record of developing and implementing effective integrated global compliance programs for biopharmaceutical companies with R&D, clinical, manufacturing, and commercial operations.
• Strong leadership and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels of the organization, spanning various functions and geographic regions.
• Excellent analytical and problem-solving abilities, with a keen attention to detail.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Advanced degrees in Science and Professional certifications in compliance are a plus.
• Commitment to upholding the highest standards of integrity, ethics, and professionalism.

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.