Senior Manager, Trial Supply Management - Princeton NJ

Military Spouse Corporate Career Network•Princeton, NJ

3d•Onsite

About The Position

The Senior Manager, Trial Supply Management provides senior-level accountability, oversight, and execution of supply strategies for all investigational products based on the scientific and regulatory confines of the drug’s development with minimal supervision.

Requirements

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 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).

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 ensure optimal use and alignment with study and corporate goals.
Demonstrates robust knowledge and confidence of GCSC processes when presenting at cross-functional meetings.
Formulates and drives strategies for continuous improvement to supply strategies for investigational products, 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.