[Hiring] Assistant General Counsel @AMER

Role Description

The Assistant General Counsel, Americas serves as the lead attorney and strategic legal partner for Telix's Phase 3 and go-to-market activities in the Americas region, the company's largest market by revenue and headcount. The role covers the full Phase 3-to-commercial product lifecycle:

• Food and Drug Administration labeling and promotional/advertising review
• Medical-Legal-Regulatory (MLR) review committee participation
• Healthcare fraud and abuse compliance (Anti-Kickback Statute safe-harbor analysis, False Claims Act risk)
• Patient support program design and compliance
• Market access and government pricing (Medicare, Medicaid, 340B Drug Pricing Program, state drug pricing transparency laws)
• Specialty distributor and specialty pharmacy contracting
• Commercial medical affairs activities
• Antitrust and unfair competition law as applied to commercial activities
• Litigation/dispute management

This is a growth role for a lawyer who wants to build a career in pharmaceutical product counseling while embedded with Americas commercial, medical affairs, and market-access leadership. It offers meaningful autonomy, close business partnership, and the opportunity to shape commercial legal support in Telix’s largest market.

Key Accountabilities:

• Serve as the primary legal business partner to Americas commercial, marketing, sales, and medical affairs leadership, providing strategic and solutions-oriented counsel on all downstream legal matters from Phase 3 development through commercial product lifecycle management.
• Advise on Food and Drug Administration labeling strategy, post-market commitments, Risk Evaluation and Mitigation Strategies, expanded access, and pipeline submissions; counsel on regulatory compliance requirements for Telix's approved and near-approval radiopharmaceutical products.
• Serve as legal lead on Medical-Legal-Regulatory (MLR) promotional review committees; assess promotional and non-promotional materials (including digital, social media, and field-force content) for off-label risk, fair balance, claims substantiation, and compliance with Food and Drug Administration advertising and promotion requirements.
• Advise on Anti-Kickback Statute safe-harbor analysis, False Claims Act risk, healthcare fraud and abuse compliance, Sunshine Act/Open Payments transparency obligations, and interactions with Healthcare Professionals, Key Opinion Leaders, patients, patient advocacy organizations, and payers.
• Counsel on patient support program design and compliance, including co-pay assistance, hub services, specialty pharmacy relationships, and patient engagement programs, ensuring consistency with federal and state healthcare fraud and abuse frameworks.
• Advise on market access, government pricing (Medicare, Medicaid, 340B Drug Pricing Program, Veterans Health Care Act pricing obligations), state drug pricing transparency laws, payer/group purchasing organization contracting, specialty distribution arrangements, and commercial launch readiness for the Americas market.
• Draft, review, and negotiate complex commercial agreements with healthcare-community counterparties including hospitals, clinics, payers, specialty pharmacies, pharmacy benefit managers, diagnostic partners, and patient/professional advocacy organizations.
• Advise on antitrust and unfair competition law as applied to commercial activities, pricing strategies, distribution arrangements, and competitive intelligence programs.
• Manage and oversee litigation and dispute matters in the Americas, including coordination with outside counsel, budget discipline, and reporting of material litigation risk to the Group General Counsel.
• Coordinate with Compliance on field activity compliance risks, speaker programs, advisory boards, Medical Science Liaison interactions, and evolving healthcare enforcement trends; monitor government enforcement actions and settlement developments relating to pharmaceutical promotion.
• Develop and maintain playbooks, templates, escalation guidance, and compliance training materials for recurring Americas commercial legal matters; proactively identify process-improvement and efficiency opportunities to strengthen the legal function's service delivery.
• Effectively manage outside counsel relationships and budgets for Americas commercial and litigation matters with spend discipline and measurable outcomes.
• 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 design, value-exchange, antitrust, distribution, and compliance considerations.

Qualifications

• 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 Food and Drug Administration 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 United States healthcare fraud and abuse laws: Anti-Kickback Statute and its safe harbors, False Claims Act, Sunshine Act/Open Payments, Stark Law (as applicable to pharmaceutical arrangements), and relevant Office of Inspector General compliance guidance and Department of Justice enforcement precedent.
• Experience with promotional review processes (Medical-Legal-Regulatory/Promotional Review Committee), Food and Drug Administration advertising and promotion requirements, and labeling/claims substantiation for pharmaceutical or biologic products.
• Experience advising on market access, government pricing (Medicare, Medicaid, 340B Drug Pricing Program), state drug pricing transparency and reporting laws, and/or specialty distribution/pharmacy contracting preferred.
• Experience managing outside counsel, adhering to litigation and advisory budgets, and driving measurable spend efficiency.
• Familiarity with antitrust/unfair competition law in the pharmaceutical commercial context, patient support program compliance, and/or life sciences litigation (product liability, government investigations, commercial disputes) preferred.

Requirements

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.

Benefits

• Competitive salaries
• Health and wellbeing incentives
• Bonus incentives
• Support for learning and development