Job Description

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.

Manager, Trial Supply Management

Location: New Jersey / Uxbridge

The Manager, Trial Supplies Management will create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.

Position 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.

•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 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. Monitor’s inventory and evaluates drug utilization versus forecast considering 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.

•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. Dynamically 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.

Degree Requirements

•BA/BS

Experience Requirements

•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.

Key Competency Requirements

•Moderate knowledge of the global drug development process and global regulatory requirements.

•Proficient and good analytical skills.

•Communication and negotiation skills.

•Proficient and good management skills.

•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/good knowledge of IVRS and CTMS systems.

•Proficient /good 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 (lead 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).

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 recognises 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. 
 
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. If you require reasonable adjustments in completing this application, or any part of the recruitment process direct your enquiries to adastaffingsupport@bms.com. Applicants can request an approval of an adjustment prior to accepting a job offer.