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:
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Lead and inspire the unlicensed medicines department with a clear strategic vision.
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Champion a dynamic, high-performing team, fostering mentorship and operational excellence.
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Create, execute, and uphold robust, compliant processes and procedures to ensure seamless unlicensed medicines supply.
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Maintain strict compliance with all regulatory requirements and quality standards.
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Partner closely with commercial, medical, regulatory, and operational teams to drive business growth and enhance patient access.
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Innovate and implement tools and strategies that empower the team to achieve profitable margins, source competitively, and optimize inventory management to reduce costs.
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Lead continuous improvement initiatives that elevate service delivery and strengthen compliance.
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Build strong relationships with healthcare professionals, regulatory bodies, and key stakeholders to promote understanding and accessibility of unlicensed medicines.
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Manage budgeting and resource allocation thoughtfully to support the unlicensed medicines function effectively.
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Act as Clinigen’s ambassador at industry forums, conferences, and regulatory meetings related to unlicensed medicines, showcasing expertise and leadership.
Requirements
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Advanced degree in Pharmacy, Life Sciences, Medicine, or related field.
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Extensive experience (10+ years) in pharmaceutical industry, preferably with unlicensed medicines or access programs.
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Proven leadership experience managing teams in a regulated environment.
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In-depth knowledge of regulations governing unlicensed medicines.
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Knowledge and understanding of TGA Special Access Scheme (SAS) and Good Clinical Practice (GCP)
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Strong strategic planning and project management skills.
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Excellent communication and stakeholder management abilities.
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Experience working collaboratively across functions including medical, regulatory, commercial, and operations.
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Ability to drive change and continuous improvement initiatives.
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Strong problem-solving and decision-making skills.
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Commitment to patient safety and regulatory compliance.
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Ability to travel nationally to attend conferences and support field-personnel, with occasion international travel.
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Full working rights in Australia.
