Assistant General Counsel, Americas

OpenKrill; United States; On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health and wellbeing incentives

Bonus incentives

Learning and development support

Job summary

The role offers strategic autonomy within a fast-paced biopharmaceutical environment and opportunities to shape regulatory and commercial strategy in Telix's largest market.

Qualifications

• 8–12+ years of legal practice with significant FDA promotional/labeling, healthcare compliance, and pharmaceutical commercialization experience.
• In-house experience at a pharmaceutical, biotechnology, or life sciences company preferred.

Responsibilities

• Serve as the primary legal partner to Americas commercial, marketing, sales, and medical affairs leadership.
• Advise on FDA labeling strategy, post-market commitments, and compliance requirements for radiopharmaceutical products.
• Lead MLR promotional review committees and assess materials for off-label risk and compliance.
• Counsel on healthcare fraud and abuse compliance, Open Payments, and interactions with HCPs and payers.
• Design and oversee patient support programs, pricing obligations, and payer contracting.
• Draft, review, and negotiate complex commercial agreements with healthcare partners.

Skills

Regulatory compliance

FDA advertising & promotion

Contract negotiation

Litigation management

Life sciences knowledge

Education

Juris Doctor (JD)

Job description

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

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, and litigation/dispute management. The role is designed for an experienced life sciences attorney who can operate with substantial autonomy as the primary, trusted legal point of contact for Americas commercial and medical affairs leadership, proactively partnering with the business rather than merely providing reactive legal review, while escalating high-risk issues appropriately.

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.

We are a dynamic, fast-growing biopharmaceutical company where everyone counts. In addition to competitive salaries, we offer health and wellbeing incentives, bonus incentives, and support for learning and development. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.

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.

Position Requirements

Education and Experience

• 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 s