Location: Somerset,NJ, USA
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 Senior Director, Global Compliance Operations as part of the Compliance team based in Somerset, NJ.
Role Overview
Senior Director of Global Operations: This role is responsible for overseeing investigations, managing conflict of interest cases, and directing third-party management processes. This role involves ensuring that compliance issues are addressed promptly and effectively, promoting a culture of transparency and ethical behavior within the organization. Reporting directly to the Global Head of Compliance, this position will manage two direct reports and engage with cross-functional stakeholders to implement strategies and support the organization's compliance objectives.
Key Responsibilities
* The Senior Director of Global Operations is responsible for:
* Reviewing and providing oversight as team members execute on compliance activities
* Monitoring ongoing compliance activities conducted by team members, providing detailed feedback, and ensuring uniform application of compliance standards across all regions
* Overseeing and guiding the development of compliance plans by team members
* Supervising the creation of detailed plans, offering strategic input and corrections to align with the company's global compliance strategy
* Thinking strategically about compliance trends and insights, informing future actions, and recommending strategies to the CCO to enhance the organization's compliance framework
* Leading and managing the investigation and hotline functions
* Developing and implementing conflict of interest policies and procedures
* Leading third-party management and due diligence activities to mitigate compliance risks
* Conducting training and awareness programs on conflict of interest and compliance issues
Requirements
* At least 15+ years of pharmaceutical industry experience with thorough knowledge of US and Global laws, regulations, and industry guidance that affect the pharmaceutical industry.
* Advance degree required
* The Senior Director, Global Compliance Operations should have current working knowledge of various laws, regulations, and industry guidance regarding compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA code, EFPIA and JPMA, US state marketing compliance laws, the Sunshine Act, FCPA, UK Bribery Act and other anti-bribery laws.
* Ability to lead and work effectively with cross functional teams and projects. Ability to lead complex projects to successful completion in an organized, efficient and effective manner. Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with feedback from multiple stakeholders.
* Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
* Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence
* Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
* Must be solutions oriented and have a demonstrated track record of effectively solving complex issues within a global compliance framework
* Strong track record of delivering results through effective team and peer leadership in matrix
* Excellent organizational skills, analytical skills, presentation skills, and results driven
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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.