Director, Ethics & Compliance Business Partner

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

 

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). 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 Director, Ethics & Compliance Business Partner as part of the Compliance team based in Bridgewater, NJ.

 

Role Overview

This role directly supports the Commercial and Medical teams and oversees the engagement of external stakeholders, providing subject matter expertise and leading the development of policies, training, and communications as needed, reviewing various materials, tactics, and engagement requests for compliance, and providing consultation to business partners across medical, clinical, and commercial functions. The position reports directly to the Global Head of Compliance and works closely with other senior leaders to align compliance strategies.

 

Key Responsibilities

 

• Embedding seamlessly with the business to provide clear, timely, and solutions-oriented compliance advice.
• Providing thought leadership on emerging risks and enforcement trends as the business evolves.
• Collaborating with the Global Operations Senior Director and other compliance leaders to ensure cohesive and integrated efforts.
• Advising internal stakeholders on compliance risks associated with external engagements.
• Overseeing the processes and systems associated with engagement of HCPs / HCOs (FMV, Contracting, etc.)
• Guiding the development and oversight of compliance frameworks for interactions with key external stakeholders.
• Overseeing product material reviews to ensure compliance with corporate standards.
• Contributing to the development of compliance policies.
• Conducting live training sessions to educate business partners.

 

 

Requirements

 

• Bachelor’s degree in related field (compliance); Masters degree in business or accounting or JD preferred. 
• 8+ years compliance and/or pharmaceutical industry experience.
• Solid experience in global pharmaceutical company with proven track record of managing projects requiring significant stakeholder involvement.
• Extensive experience advising Commercial and Medical Affairs .
• Knowledge of adboards, speaker programs, FMV compliance principles .
• Strong understanding of compliance processes and activities common to the U.S. biotech/pharmaceutical industry.
• Strong understanding of healthcare compliance and enforcement environment.
• High degree of familiarity with False Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulations.
• Understanding of how to efficiently operationalize OIG’s seven elements.
• Team player with proven ability to develop trusting and productive relationships within and across the business areas to seek alignment on objectives and achieve results .
• Ability to work independently and prioritize projects in a rapid growth environment as well as exercise sound judgment as to when to escalate matters to management.
• Excellent written and oral communication skills.
• High level of integrity with good ethical core values.
• Excellent time management and organizational skills with strong attention to detail, organizational, analytical and people skills.
• Sense of humor.

 

 

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): $193,629—$254,137 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

 

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

 

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

  For information related to our privacy notice, please review: Legend Biotech Privacy Notice.