# Head of Unlicensed Medicines

> Clinigen · Warriewood, Australia (Hybrid) · Full-time · Posted 2026-06-05

**Workplace:** hybrid

**Department:** Commercial Functions

## Description

The Head of Unlicensed Medicines is a senior leadership role responsible for steering the dynamic Unlicensed Medicines Business Unit, which encompasses the On-Demand Unlicensed Medicine, Clinical Trial Services, and Managed Access divisions.

By bringing visionary strategic leadership, deep operational expertise, and strong cross-functional collaboration, you will champion the mission to forge clear pathways ensuring patients gain access to essential medicines. Your leadership will be instrumental in upholding Clinigen's reputation as a trusted partner in delivering access to unlicensed medicines.

**Key Responsibilities:**

-   Lead and inspire the unlicensed medicines department with a clear strategic vision.
-   Champion a dynamic, high-performing team, fostering mentorship and operational excellence.
-   Create, execute, and uphold robust, compliant processes and procedures to ensure seamless unlicensed medicines supply.
-   Maintain strict compliance with all regulatory requirements and quality standards.
-   Partner closely with commercial, medical, regulatory, and operational teams to drive business growth and enhance patient access.
-   Innovate and implement tools and strategies that empower the team to achieve profitable margins, source competitively, and optimize inventory management to reduce costs.
-   Lead continuous improvement initiatives that elevate service delivery and strengthen compliance.
-   Build strong relationships with healthcare professionals, regulatory bodies, and key stakeholders to promote understanding and accessibility of unlicensed medicines.
-   Manage budgeting and resource allocation thoughtfully to support the unlicensed medicines function effectively.
-   Act as Clinigen’s ambassador at industry forums, conferences, and regulatory meetings related to unlicensed medicines, showcasing expertise and leadership.

## Requirements

-   Advanced degree in Pharmacy, Life Sciences, Medicine, or related field.
-   Extensive experience (10+ years) in pharmaceutical industry, preferably with unlicensed medicines or access programs.
-   Proven leadership experience managing teams in a regulated environment.
-   In-depth knowledge of regulations governing unlicensed medicines.
-   Knowledge and understanding of TGA Special Access Scheme (SAS) and Good Clinical Practice (GCP)
-   Strong strategic planning and project management skills.
-   Excellent communication and stakeholder management abilities.
-   Experience working collaboratively across functions including medical, regulatory, commercial, and operations.
-   Ability to drive change and continuous improvement initiatives.
-   Strong problem-solving and decision-making skills.
-   Commitment to patient safety and regulatory compliance.
-   Ability to travel nationally to attend conferences and support field-personnel, with occasion international travel.
-   Full working rights in Australia.

## Apply

[Apply at Clinigen](https://apply.workable.com/clinigen/j/22A56BCA43/apply)

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