Assistant General Counsel, Americas

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

⚖️ Legal Counsel / General Counsel

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Serve as the primary legal business partner to Americas commercial, marketing, sales, and medical affairs leadership • Provide strategic legal counsel from Phase 3 development through commercial product lifecycle management • Advise on FDA labeling strategy, post-market commitments, REMS, expanded access, pipeline submissions, and regulatory compliance • Lead Medical-Legal-Regulatory promotional review committees and assess promotional and non-promotional materials for off-label risk, fair balance, claims substantiation, and FDA compliance • Advise on healthcare fraud and abuse compliance, Anti-Kickback Statute safe harbors, False Claims Act risk, Sunshine Act/Open Payments, and healthcare stakeholder interactions • Counsel on patient support programs, co-pay assistance, hub services, specialty pharmacy relationships, and patient engagement programs • Advise on market access, government pricing, drug pricing transparency, payer/GPO contracting, specialty distribution, and commercial launch readiness • Draft, review, and negotiate complex commercial agreements with healthcare counterparties • Advise on antitrust and unfair competition law for commercial activities, pricing, distribution, and competitive intelligence • Manage Americas litigation and disputes, including outside counsel, budgets, and material-risk reporting to the Group General Counsel • Coordinate with Compliance on field activities, speaker programs, advisory boards, MSL interactions, and enforcement trends • Develop legal playbooks, templates, escalation guidance, and compliance training materials • Manage outside counsel relationships and budgets with spend discipline • Provide Americas clinical trial support, including CTAs, site agreements, investigator relationships, IITs, publications, medical affairs programs, advisory boards, and MSL frameworks • Structure HCP/KOL engagement programs with appropriate legal and compliance considerations

🎯 Requirements

• Juris Doctor (JD) from an accredited law school • Active bar admission in at least one United States state required • 8–12+ years of legal practice with significant FDA promotional/labeling, healthcare compliance, pharmaceutical commercialization, market access, and/or commercial healthcare litigation experience • At least 4 years of in-house experience at a pharmaceutical, biotechnology, or life sciences company strongly preferred • Substantive knowledge of U.S. healthcare fraud and abuse laws, including the Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, Stark Law, OIG guidance, and DOJ enforcement precedent • Experience with promotional review processes, FDA advertising and promotion requirements, and labeling/claims substantiation for pharmaceutical or biologic products • Experience advising on market access, government pricing, state drug pricing transparency/reporting laws, and/or specialty distribution/pharmacy contracting preferred • Experience managing outside counsel, litigation and advisory budgets, and measurable spend efficiency • Familiarity with antitrust/unfair competition law, patient support program compliance, and/or life sciences litigation preferred • Strong communication, collaboration, adaptability, ethical behavior, and continuous-learning capabilities

🏖️ Benefits

• Competitive salaries • Health and wellbeing incentives • Bonus incentives • Support for learning and development • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Hybrid and remote work arrangements (company-wide)