Senior Director, CMC Project Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the planning, coordination, and execution of CMC activities across various development programs.

• Collaborate with CMC functional leaders, cross-functional teams, and CDMOs to convert CMC strategy into comprehensive project plans.

• Create and sustain integrated CMC project plans, intricate timelines, and Gantt charts.

• Monitor CMC activities, milestones, deliverables, dependencies, commitments, risks, issues, and changes in scope.

• Recognize schedule risks, resource limitations, dependencies, and potential delays; escalate concerns to leadership.

• Maintain project dashboards and deliver status updates to management and project teams.

• Plan, organize, and facilitate internal CMC/Technical Operations meetings.

• Document meeting minutes and keep action-item and decision logs.

• Act as the project-management liaison between Technical Operations/CMC and Clinical, Regulatory, Quality, Finance, Legal, and Program Management.

• Align CMC timelines with clinical and regulatory development plans.

• Assist in portfolio planning, management reporting, and executive-level reviews.

• Develop and oversee CMC project budgets and financial forecasts.

• Review and monitor vendor/CDMO invoices in relation to contracts, statements of work, purchase orders, milestones, and payment schedules.

• Maintain financial trackers and assist with budget planning, reforecasting, and long-term financial strategy.

• Create and uphold organized CMC electronic filing and document-management systems.

• Organize CMC SharePoint folders and ensure adherence to filing conventions for project, manufacturing, analytical, stability, regulatory, contract, meeting, budget, and vendor documentation.

⛳️ Requirements

• Proven experience in project management within the pharmaceutical or biotech industry.

• Strong understanding of CMC regulatory requirements and development processes.

• Proficient in project management tools and techniques, including Gantt charts and financial tracking.

• Excellent communication and interpersonal skills, with the ability to work collaboratively across multiple teams.

• Detail-oriented with strong organizational skills to manage complex project timelines and documentation.

• Ability to identify and mitigate risks, and escalate issues effectively.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.