Global Program Manager- Clinical Packaging Operations

Title

Global Program Manager – Clinical Packaging Operations

Position Summary

The Global Program Manager (GPM) serves as the strategic single point of contactfor clients. Responsible for the end-to-end operational delivery of global clinical supply services at Xerimis. This high-impact role drives alignment across cross-functional teams, ensuring on-time, compliant execution of study milestones while developing strong partnerships with sponsors and Internal Stake holders.

Position Reports to:

Director, Global Program Management

Position Supervises:

Global Program Managers

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Act as the primary liaisonfor sponsors, owning all communications, decisions, and deliverables throughout the duration of global clinical trials.
• Provide strategic leadership across internal teams and vendors to align study execution with sponsor expectations, timelines, and regulatory requirements.
• Develop and manage comprehensive project plans, timelines, and study dashboards to track progress and provide key insights to stakeholders.
• Lead cross-site coordination between US and UK and NL facilities to deliver consistent global execution.
• Proactively identify risks and lead resolution strategies, ensuring uninterrupted study supply and sponsor satisfaction.
• Initiate and lead kickoff meetings, establish communication plans, and set cadence for ongoing alignment with sponsors and internal teams.
• Track the finical heath of the project. Facilitate change order management and support quoting and invoicing processes in collaboration with Business Development and Finance.
• Collaborate with Qualified Persons and regulatory stakeholders to support timely release of clinical supplies.
• Champion continuous improvement initiatives, leveraging client feedback and operational insights to refine processes.
• Serve as a trusted strategic advisor, contributing to business reviews and future program planning with sponsors.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree or equivalent work experience
• Bachelor’s degree or equivalent work experience required.
• 5+ years of experience in clinical supply management or a related pharmaceutical function.
• Strong command of GMP/GDP guidelines, IRT systems, supply forecasting tools, and global clinical trial logistics.
• Proven ability to lead complex programs across time zones and functions, with a strategic mindset and client-focused approach.
• Excellent communication, relationship management, and project documentation skills.
• Proficiency in Microsoft Office and project management software.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is required to sit; stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. While performing the duties of this job, the employee is exposed to warehouse and operations (packaging) environments including regular exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.