Associate Director, CMC Project Management

Essential Job Functions

• 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 mitigation strategies, and implement approved action plans.
• 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.
• Build productive relationships across the organization and influence decision making with leadership audiences.
• Organizes and prioritizes critical issues and strategic communications for senior management.

Skills and Qualifications

• 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.
• Background in a CMC discipline and/or project management experience with all CMC disciplines is preferred.
• Strong skills and experience with Adobe and Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Proficient in project management software such as Asana, Monday.com, Smartsheet, or MS Project.
• Broad business understanding and 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.

Competencies

Verbal and Written Communication skills, Proofreading, Editing, Interpersonal skills, Adaptability, Organizational skills, Problem Solving, Cross-Functional, Matrix Management, Conflict Management, Leadership.

Working Conditions

Position may require periodic evening and weekend work. Infrequent overnight travel may occur. This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office.