Manager, Trial Supply Management

Bristol Myers Squibb•Princeton, NJ

3d•Hybrid

About The Position

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

Requirements

Minimum 2 years Pharma industry related experience.
Minimum 1-year 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 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.
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).

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.
Partners with the Clinical Supply Lead (CSL) in planning and communicating 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.
Contributes to strategies for continuous improvement, both departmental and/or inter-departmental.
Influences clinical and development timelines, study design and country selection.
Responsible for reviewing and working with the CSL to provide any contributions to the clinical protocol and directly responsible for protocol amendments, communicating timelines and investigational product strategies to study and cross-functional teams
Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
Issues Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with 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.
Derives enhancements to improve the timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account global and country Regulatory and QP Release requirements.
Participates in development, review and approval of Interactive Response Technology (IRT) specifications.
Executes 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 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.
Supports associated actions stemming from change controls.
In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
Manages conflicts/issues with internal and external partners and customers.
Writing of departmental procedural documents as applicable.
Performs other tasks as assigned.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Unlimited paid sick time
Up to 2 paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day.