Associate Director, CMC Project Management
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. Working directly with the CMC lead, the role drives operational execution of CMC activities and develops and maintains detailed project plans for drug substance, drug product, device, and analytical development workstreams. The position ensures that CMC milestones are achieved on time and within budget, with a strong focus on coordinating external manufacturing partners and enabling CMC technical experts to focus on scientific and engineering challenges. The role oversees integrated planning, schedules, scope, budgets, resources, risks, and cross-functional deliverables. It facilitates communication and decision-making among program teams and senior management, supports standardized project management practices, and coaches colleagues undertaking project management duties. This is a hybrid role based in Xeris’ Chicago office, requiring at least three days per week in the office; that requirement may change at management’s discretion. Periodic evening and weekend work may be required, and infrequent overnight travel may occur. The anticipated base salary range is $155,200–$232,800. Non-sales employees are eligible for an annual bonus, and employees may be eligible for equity or long-term incentive awards, where applicable. The company offers paid time off, health, vision, and dental insurance options, 401(k) retirement benefits, and other benefits for eligible employees.
Requirements
- Bachelor’s degree in business or another related life sciences field.
- At least 7 years of CMC project management experience, or at least 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 PowerPoint.
- Proficiency with project management software such as Asana, Monday.com, Smartsheet, or MS Project.
- Broad business understanding and awareness of specific industry sectors.
- Understanding of drug development and the interdependencies of clinical development, CMC/PDTO, regulatory affairs, medical affairs, and commercial functions.
- Competencies in verbal and written communication, proofreading, editing, interpersonal skills, adaptability, organization, problem solving, cross-functional collaboration, matrix management, conflict management, and leadership.
Nice To Haves
- Background in a CMC discipline and/or project management experience across all CMC disciplines.
Responsibilities
- Develop, maintain, and manage integrated project plans for CMC activities, including process development, scale-up, validation, stability studies, and clinical trial material and supply.
- Track progress against timelines, manage the critical path, and ensure functional deliverables are completed on schedule.
- Monitor project scope, budget, and resources, and provide timeline and status reports to stakeholders.
- Maintain the CMC risk management plan with the PDTO team; identify risks, facilitate mitigation strategies, implement approved action plans, and escalate significant risks as appropriate.
- Organize and facilitate cross-functional meetings focused on objectives, actions, and decisions.
- Serve as a central communication point for the PDTO team and align team members on timelines, priorities, and interdependencies.
- Support the PDTO lead with budget management, assist with resource planning, and identify potential budget variances.
- Implement and promote standardized project management tools and methodologies, improve execution, and establish best practices at Xeris.
- Coach colleagues who take on project management responsibilities when a project manager cannot be assigned.
- Build productive relationships across the organization and enable responsibility at all levels to support influence and timely decisions.
- Build consensus and influence cross-functional and leadership decisions using timely analysis and options.
- Organize and prioritize critical issues and strategic communications for senior management.
- Perform other duties and projects as needed.
Benefits
- Paid time off benefits.
- Health insurance options.
- Vision insurance options.
- Dental insurance options.
- 401(k) retirement benefits.
- Annual bonus eligibility for non-sales employees.
- Equity or long-term incentive awards, where applicable.
- Comprehensive benefits package for eligible employees.
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What This Job Offers
Job Type
Full-time
Career Level
Director
