Trial Supplies Manager

Working with Us Challenging Meaningful Life-changing Those aren t words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here uniquely interesting work happens every day in every department From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it You ll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams Take your career farther than you thought possible 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 Read more Trial Supplies Manager 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 an organization within Global Supply Chain GSC GSC s 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 BMS s 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 Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug s development with minimal supervision Roles and Responsibilities Collaborates with internal Global Clinical Supply Chain GCSC teams and external Customers and Service Providers including but not limited to Global Drug Development Pharmaceutical Development Product Development Quality PDQ External Vendors and Medical to ensure all needs are met Proactively defines plans and communicates the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals Demonstrates strong knowledge of GCSC processes when presenting at cross-functional meetings Responsible for identifying and supporting strategies for continuous improvement both departmental and or inter-departmental Influences clinical and development timelines study design and country selection Directly responsible for reviewing and providing input to draft clinical protocols communicating timelines and investigational product strategies to study and cross-functional teams Develops supply forecasts for studies through evaluation of the clinical development plan and protocol analysis Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines Issues Manufacturing and Packaging Labeling requests to Clinical Supply Operations CSO in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team Chemistry Manufacturing Controls CMC team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements Monitor use date of investigational drug product for assigned protocols Support use date extension activities such as generation of Use Date Extension UDE memo and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements Participates in development review and approval of Interactive Response Technology IRT specifications Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings Study Team meetings Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting highlighting any risks and mitigation strategies Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements Attends meetings with vendors and generates purchase requisitions as needed Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans Acts as the main Clinical Supplies contact person for the assigned compound and associated studies leading communications regarding global supply strategy with study team as appropriate Supports associated actions stemming from change controls In collaboration with Compliance prepare eTMF CSR appendices and batch listings to support inspection readiness activities Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution Manages conflicts issues with internal and external partners and customers Writing of departmental procedural documents as applicable Performs other tasks as assigned Skills and Qualifications Minimum 2 years Pharma industry related experience Minimum 1 years Clinical Supplies Development with global experience or equivalent experience An equivalent combination of education and experience may substitute Moderate Strong knowledge of the global drug development process and global regulatory requirements Proficient and strong analytical skills Strong communication and negotiation skills Proficient and strong Project management skills Strong knowledge of Forecasting and Planning and proficient knowledge of related areas i e Manufacturing Packaging Labeling IVRS Logistics Quality Stability etc Proficient knowledge of import export requirements Proficient Strong knowledge of IVRS and CTMS systems Proficient Strong knowledge of industry technology Applies and drives Forecasting and Planning activity as it relates to protocol Ability to build drive internal team consensus Translates broad strategies into specific objectives and action plans Team and individual leadership leads courageously Oral and written communication fosters open communication Conflict resolution manages disagreements Negotiation Manages Execution Results Driven Analysis of Issues Effective Speaking Builds Relationships Influencing manages influencing others Coaching and mentoring fosters teamwork Education Experience Licenses Certifications BA BS in Science IT or Business preferably with focus on IT Digitization Supply Chain 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 If you come across a role that intrigues you but doesn t perfectly line up with your resume we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science TM every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential site-by-design field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100 of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations