Associate Director, Trial Supplies Management

Associate Director, Trial Supplies Management At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science.In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Global Clinical Supply Chain (CSC) is a new organization within Global Supply Chain (GSC). GSCs vision is to be a patient-centric, integrated supply chain, launching and supplying innovative products that deliver hope to patients through life-changing medicines. The Global Clinical Supply Chain (CSC) organization contributes to this vision by working seamlessly across the enterprise to supply BMSs global portfolio of clinical studies. CSC represents an innovative organizational model, an innovation that enables BMS for a future in which commercial supply chains will be increasingly similar to clinical supply chains due to advances in personalized medicine and targeted therapies. Position Summary This position is responsible for all matters pertaining to the global forecasting and planning of investigational materials for clinical studies with a primary responsibility for leading the development and execution of investigational material supply strategies for global studies. The incumbent will lead a group of Trial Supply Managers and/or Inventory Planning & Coordination Specialist/Managers responsible for obtaining long term forecasts and developing supply strategies for each study. Working as a key member within Trial Supply Management, the position will proactively recognize and address any technical and regulatory issues associated with the products quality or suitability for intended use. The incumbent will also be considered a subject matter expert on all information regarding the global use of investigational material in clinical studies. Roles and Responsibilities Directly oversee and manage the development and implementation of supply strategies for all investigational material based on study needs and scientific and regulatory confines of the drug development. Directly oversee the management of investigational material inventories, related study forecasts and assessments. Accountable for timely, cost effective and high-quality execution of approved strategies. Manage project budget and project timelines, with the support of the Clinical Supply Program Team, Global Clinical Supply Chain management and functional leadership, ensuring appropriate and timely resource allocation to achieve project goals and deadlines. Provide to functional head, and continuously update, a balanced appraisal of the project status, including risk, cost, and value to stakeholders. Provide direction to Trial Supply Managers on study protocols for packaging and label design, distribution plan and IRT design for global studies. Provide leadership and vision needed to create, implement, execute and maintain processes that ensure production deliverables and cost effectiveness. Influence and counsel senior management in the establishment of these systems. Identify and evaluate fundamental issues pertaining to the clinical supply chain through assessment of intangible variables and provide plans for resolution. Independently make decisions to ensure effective utilization of global investigational material resources based on capacities and resources. Communicate project status and readiness, business and technical issues and risks and options across function lines and management up to and including executive levels. Participate in and provide leadership to Trial Supply Management process improvement Initiatives resulting in cohesive supply chain activities Foster strong collaboration with all functional partners, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical, to assure clinical trials are conducted efficiently and effectively solve abstract problems across functional areas of the business. Manage a team of Trial Supply Managers and/or Inventory Planning & Coordination Specialist/Managers. Hire, train and retain team members to develop the second line of management. Performs other tasks as assigned. Skills and Qualifications 10 yrs. experience in the pharmaceutical industry with 7 yrs. experience in drug development, clinical supply chain management and/or clinical manufacturing and 3 years in project management OR Equivalent experience. An equivalent combination of education and experience may substitute. Experience across multiple functional areas (i.e. clinical, regulatory, quality) demonstrating a broad understanding of pharmaceutical development. In-depth knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment. Extensive experience with planning and execution of investigational materials supply strategies. Demonstrated strategic and leadership skills. Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders. Result oriented individual to execute strategy and meet objectives. Experience managing change in a dynamic, complex environment. Strong background in cGxPs and ICH requirements. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Location: Hyderabad, IN

Posted Date: 9/13/2024