Senior Trial Supplies Manager

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Senior 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 a new 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. Working independently, they will be capable of mentoring others whilst acting as a consultant to others outside of the role.

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 ensure optimal use and alignment with study and corporate goals. Demonstrates robust knowledge and confidence of GCSC processes when presenting at cross-functional meetings.

Responsible for generating and driving 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 complex 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 and leads issue resolution with internal and external partners and customers.

Writing of departmental procedural documents as applicable.

Performs other tasks as assigned.

Skills and Qualifications

Minimum 5+ years Pharma industry related experience.

Minimum 3 years Clinical Supplies/Development with global experience or equivalent experience.

An equivalent combination of education and experience may substitute.

Advanced knowledge of the global drug development process and global regulatory Requirements.

Advanced analytical skills.

Advanced communication and negotiation skills.

Advanced project management skills.

Advanced knowledge of forecasting and planning and proficient knowledge of related areas i.e., Manufacturing, Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc.

Strong knowledge of import / export requirements.

Strong knowledge of IVRS and CTMS systems.

Advanced knowledge of industry technology and how to apply source innovative solutions and new industry best practices.

Develops and applies unique ideas and new methods to achieve higher performance and excellence.

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).

Delegating (provides direction).

Coaching and mentoring (fosters teamwork).

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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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  adastaffingsupport@bms.com . Visit  careers.bms.com/eeo-accessibility  to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  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:  https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at  https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at  TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606884 : Senior Trial Supplies Manager