Head of Unlicensed Medicines

About the role

The Head of Unlicensed Medicines will lead Clinigen’s Unlicensed Medicines Business Unit, overseeing On‑Demand Unlicensed Medicine, Clinical Trial Services and Managed Access divisions. This senior leadership position drives strategic vision, operational excellence and cross‑functional collaboration to ensure patients receive essential unlicensed medicines.

Key responsibilities

• Define and communicate a clear strategic vision for the unlicensed medicines department.
• Lead, mentor and develop a high‑performing team, fostering operational excellence.
• Design, implement and maintain compliant processes to guarantee seamless supply of unlicensed medicines.
• Ensure strict adherence to all regulatory and quality standards.
• Collaborate with commercial, medical, regulatory and operational teams to grow the business and improve patient access.
• Introduce tools and strategies to achieve profitable margins, competitive sourcing and cost‑effective inventory management.
• Drive continuous improvement initiatives to enhance service delivery and compliance.
• Build and maintain relationships with healthcare professionals, regulators and key stakeholders.
• Manage budgeting and resource allocation for the function.
• Represent Clinigen at industry forums, conferences and regulatory meetings.

Required profile

• Advanced degree in Pharmacy, Life Sciences, Medicine or a related field.
• 10+ years of experience in the pharmaceutical industry, preferably with unlicensed medicines or access programmes.
• Proven leadership experience in a regulated environment.
• Strong understanding of regulations governing unlicensed medicines.
• Ability to travel nationally and occasionally internationally.
• Full working rights in Australia.

Required skills

• Knowledge of the TGA Special Access Scheme (SAS).
• Understanding of Good Clinical Practice (GCP).