The Investigational Product (IP) Study Supply Lead is responsible for oversight of the IP supply chain, including forecasting the IP distribution of multiple clinical trials. This includes ensuring activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and applicable Standard Operating Procedures (SOPs); contributing to ongoing process improvement initiatives; collaborating and interacting with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and Chemistry, Manufacturing and Controls (CMC), external manufacturing, and stability. This role applies to internally sourced studies and/or Contract Research Organization (CRO)/Partnered studies.

The duties and responsibilities of this position include but are not limited to the following:

• Lead supply planning and develop timelines to manage supply chain risk and cost, ensure end-to-end supply chain in alignment with study expectations and manage and track IP inventory through life of program;
• Oversee IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites;
• Serve as lead logistics liaison for the functional area in supply planning, including demand forecasting, and vendor identification, selection and set-up;
• Proactive triage, documentation, escalation, resolution and correction/improvement of issues involving a range of technical, quality, regulatory and operational issues to ensure delivery to patient without compromising quality or cost;
• Contribute to the development of IP-related study documents including protocols, study and pharmacy manuals;
• Work with the clinical team to design a packaging configuration and supply strategy taking cost and efficiency into consideration;
• Represent Clinical Supplies on global clinical project teams; work with other line functions and external partners to manage complex projects.

• Excellent verbal, written, and interpersonal skills, and ability to influence a small team of functional experts;
• Bilingual in English and Mandarin Chinese;
• Must be independent, a self-starter, and have the ability to “roll-up sleeves” to produce work-products without “people working for you”;
• Must be proactive (but have sufficient “soft skills”) to maintain and/or accelerate timelines for achieving clinical operational milestones;
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems;
• Investigational Product forecasting skills, accounting for global cost and risks, and regional regulatory requirements;
• Ability to effectively multi-task and prioritize;
• Project management and organizational skills;
• Computer skills with competency in Microsoft Word and Excel;
• Study Tools including electronic system skills, Interactive Voice Response Systems (IVRS)/Interactive Web Response Systems (IWRS), Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC);
• Cross-functional and cross-cultural awareness;
• Ability to work flexibly and efficiently in a remote multi-national matrix environment.

• Bachelor's degree and at least 3 years of relevant experience in the biotechnology/pharmaceutical industry, with work experience in clinical supply management;
• Experience in biologics and cold chain IP management is preferred;
• Experience in developing global trial drug supply plans;
• Working knowledge of global and regional clinical drug development process and clinical trial methodology;
• Demonstrated knowledge of international clinical pharmaceutical standards, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) guidelines and regulatory compliance.