Head of Unlicensed Medicines

About the role

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. 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.

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Company Intel

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