Head of Unlicensed Medicines

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.