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Manager, Trial Supply Management
Manager, Trial Supply ManagementNew Jersey Staffing • Princeton, NJ, US
Manager, Trial Supply Management

Manager, Trial Supply Management

New Jersey Staffing • Princeton, NJ, US
14 days ago
Job type
  • Full-time
Job description

Manager, Trial Supply Management

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.

The role of the Manager, Trial Supply Management is to create and maintain supply strategies for all investigational products 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.

Key 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.
  • 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.

Qualifications & Experience :

  • B.A. / B.S.
  • 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).
  • 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.

    Compensation Overview

    Princeton - NJ - US : $114,150 - $138,319 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Years holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    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 adastaff

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