Director, Ethics & Compliance Business Partner

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From three R&D sites around the world, Legend Biotech applies 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 autoleucel (cilta-cel). This 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.

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 & Qualifications

• Bachelor’s degree in related field (compliance).
• Master’s 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 ad-boards, speaker programs, and 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 business areas.
• Ability to work independently and prioritize projects in a rapid growth environment.
• 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.
• Sense of humor.

Compensation & Benefits

• Base Pay Range: $193,629–$254,137 USD.
• Performance-based bonus and/or equity available to employees in eligible roles.
• Medical, dental, and vision insurance.
• 401(k) retirement plan with company match that vests fully on day one.
• Eight (8) weeks of paid parental leave after three (3) months of employment.
• Paid time off: vacation, personal, sick, floating holidays, plus 11 company holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance; short- and long-term disability coverage.
• Legal assistance and supplemental plans (pet, critical illness, accident, hospital indemnity).
• Voluntary commuter benefits.
• Family planning and care resources; well-being initiatives.
• Peer-to-peer recognition programs.