Job Description:

The Opportunity:The Clinical Trial Supply (CTS) Asset/Program Lead (Associate Director) is an experienced clinical supply chain professional accountable for the development and execution of the clinical supply operational strategy for an asset or program (a group of related, typically larger and/or more complex, clinical studies) throughout the multi-year lifecycle.  The CTS Asset/Program Lead is responsible for clinical supply operational planning activities by influencing protocol design and leveraging concepts like pooling to maximize reliability and efficiency across the asset or program.  The incumbent will also supervise staff responsible for, and/or lead, clinical supply activities such as kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing and managing the depot network and distribution to clinical sites, and ensuring final return and destruction for clinical studies within the asset/program on-time and within budget. The CTS Asset/Program Lead is a contributor to CTS strategy development, and sponsors/leads improvement initiatives for the clinical supply chain.Responsibilities:1.    Establishes and oversees the creation and execution of multi-year clinical supply strategies and plans for an asset or program.  Develops long-term clinical supply forecasts to support company planning processes.  Ensures alignment of these plans with the multidisciplinary Core Project Teams and Clinical Development Teams, as well as with Commercial, Operations and Global Supply Planning.  2.    Influences protocol design and leverages concepts like pooling, late stage customization, standardization and consumption driven resupply across studies in order to maximize reliability and efficiency across the asset or program.   Develops proactive risk mitigation strategies and corrective action plans to address asset or program issues.3.    Considers impact of asset or program clinical supply chain on sites and patients. Gathers feedback where possible and leverages innovative concepts (i.e. site to subject or direct to patient logistics) to improve patient and site experience.4.    Leads a team of CTS Study Managers and/or CTS Study Specialists to supply all clinical studies in the asset or program with drug and ancillary materials.  Mentors junior staff. Participates in hiring of CTS.  Manages performance and career development of team members.  5.    Represents CTS in Clinical Development Teams and Study Execution Teams.  Reviews study protocols and provides clinical supply input.  Determines clinical kit design based on protocol needs.  Plans and forecasts product volume requirements for assigned global clinical programs based on clinical study assumptions. Adjusts forecasts monthly based on study progress and changes to clinical and/or supply assumptions.  Leverages simulation modeling capabilities to optimize clinical supply plans and minimize the effect of inherent uncertainties.6.    Establishes global network of regional and local depots to distribute drug supplies and ancillary supplies to countries and sites in asset or program.  Manages timely and compliant importation of drug supplies and ancillary supplies into regional and local depots.  Ensures on time delivery of drug supplies and ancillary supplies from depots to clinical sites and/or patients. Establishes cold chain management parameters for storage and distribution of drug supplies and ancillary supplies.  Ensures temperature control of shipments from manufacturing sites to depots to clinical sites and resolution of temperature excursions.7.    Ensures development of clinical trial supply documentation and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product Handling Manuals, product reconstitution videos).  Presents clinical supply plans, approaches and logistics at international investigator meetings.8.    Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies.  Participates in audits and regulatory inspections as needed.  Responsible for ensuring proper documentation is completed and filed throughout the study and after study closure.  Investigates deviations, product technical complaints and temperature excursions.  Develops global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities.9.    Ensures creation and accuracy of budgets and forecasts including internal and external product costs, packaging and labeling costs, storage and distribution costs, and comparator and ancillary material costs across the asset or program.  10.    Independently leads cross-functional process improvement projects for the clinical supply chain.  Drives ongoing continuous improvements in clinical drug supply efficiency and cost-effectiveness. Contributes to the clinical supply chain strategy.Education & Requirements:•    University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience•    Minimum of 8 years' experience in biopharma R&D or supply chain including 5 years' experience in clinical trial supplies leading global studies; experience managing a teamOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.Please take the time to review our benefits site to see what's available to you as a CSL employee.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Behring!