Associate Director, CMC Project Management

Xeris Pharmaceuticals•Chicago, IL

7d•Hybrid

About The Position

The Associate Director, CMC Project Management is a dedicated project management expert supporting the Product Development/Technical Operations “PDTO” function for the XP-8121 development program. This role partners directly with the CMC lead to drive the operational execution of all CMC related activities for the XP-8121 program. The role is responsible for developing and maintaining detailed project plans for all drug substance, drug product, device, and analytical development workstreams. This individual will ensure that all CMC milestones for the 8121 program are met on time and within budget to support broader program goals, with a heavy focus on managing and coordinating external manufacturing partners. This role provides the essential project management structure that allows CMC technical experts to focus on scientific and engineering challenges.

Requirements

Bachelor’s degree in business, or other related life sciences
Minimum of 7+ years in CMC project management or 7+ years combining project management and CMC execution on Phase 3 development programs.
Strong skills and experience with Adobe and Microsoft Office Suite, including Word, Excel, and Power Point
Proficient in project management software such as Asana, Monday.com, Smartsheet, or MS Project.
Broad business understanding and a good awareness of specific industry sectors
Understanding of the drug development process and the interdependencies of key functions, including clinical development, CMC/PDTO, regulatory affairs, medical affairs, and commercial.

Nice To Haves

Background in a CMC discipline and/or project management experience with all CMC disciplines is preferred

Responsibilities

Develop, maintain, and manage detailed, integrated project plans for all CMC activities, including process development, scale-up, validation, stability studies, and clinical trial material and supply.
Proactively track progress against established timelines, identify and manage the critical path, and ensure that deliverables from all functions are completed on schedule.
Monitor project scope, budget, and resources, providing timeline and comprehensive status reports to key stakeholders.
In partnership with the PDTO team, maintain the CMC risk management plan. Proactively identify CMC risks, facilitate the development of mitigation strategies, and implement approved action plans, escalating significant risks as appropriate.
Organize and facilitate cross-functional team meetings, ensuring a focus on clear objectives, actions, and decisions.
Serve as a central point of communication for the PDTO team, ensuring all members are aligned on timelines, priorities, and interdependencies.
Support the PDTO lead in managing the PDTO budget. Assist team members with resource planning and identify potential budget variances.
Implement and champion the use of standardized project management tools and methodologies to drive efficiency and consistency in program execution.
Continually improve project management execution to establish best practices at Xeris.
Act as an organization-wide resource to coach others who take on project management duties on projects where a project manager cannot be assigned.
Builds productive and positive relationships across the organization by enabling responsibility at all levels to drive influence and timely decisions as attributed to effective and efficient project management.
Elevates issues for perspective only where possible and for decisions either strategic or critical to the company.
Builds consensus to drive to the best decision possible in a reasonable timeframe among cross-functional teams.
Influences decision making with leadership audiences by providing timely analysis and options.
Organizes and prioritizes critical issues and strategic communications for senior management to facilitate efficient decision making.
Performs other duties and projects as needed.