Remote Associate Director, CMC Operations & Strategy

Ladders; United States; À distance; USD 155 000 - 190 000; Plein temps

Avantages offerts par ce poste

Health insurance

Flexible time off

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability & life insurance

Bonus & equity grants

Year-end shutdown

Résumé du poste

The Ladders is seeking an Associate Director, CMC Operations to lead planning and execution of CMC workstreams from development through regulatory submission. This role partners with Technical Operations, CDMOs, Regulatory, Finance, and senior leadership to keep programs on track and ensure timely submissions.

The ideal candidate brings 10+ years in pharmaceutical drug development with 5+ years in CMC project management, strong Smartsheet use, budgeting experience, and a track record of

Qualifications

• 10+ years in pharmaceutical drug development, with 5+ years in CMC PM or related role.
• Strong understanding of CMC development, technology transfer, and manufacturing with CDMOs.
• Proven ability to manage multiple projects simultaneously.
• Advanced proficiency in Smartsheet for project timelines and dashboards.
• Experience in project budgeting, forecasting, and expense tracking.
• Excellent communication and presentation skills, especially with senior leadership.
• Demonstrated creativity and problem-solving skills in ambiguous situations.
• Experience working in interdisciplinary and cross-cultural teams.

Responsabilités

• Lead planning and execution of CMC workstreams from development to regulatory submission
• Build and maintain integrated CMC project plans and timelines in Smartsheet
• Facilitate cross-functional Technical Operations Program Teams, driving decisions and tracking action items
• Coordinate activities with CDMO partners, ensuring deliverables meet contracted timelines
• Identify and mitigate project risks and dependencies, developing contingency plans as needed
• Coordinate CMC contributions to regulatory submissions, tracking timelines for authoring and approvals
• Communicate project status and key issues to management and project teams in a timely manner
• Support departmental budget planning and expense tracking in collaboration with Finance
• Drive continuous improvement of CMC project management tools and processes

Connaissances

CMC project management

Pharmaceutical development

CDMO collaboration

Budgeting & forecasting

Cross-functional leadership

Executive communication

Risk management

Multitasking

Problem solving

Cross-cultural teamwork

Outils

Smartsheet

Description du poste

The Ladders is seeking an Associate Director, CMC Operations to lead planning and execution of CMC workstreams from development through regulatory submission. This role partners with Technical Operations, CDMOs, Regulatory, Finance, and senior leadership to keep programs on track and ensure timely submissions.

The ideal candidate brings 10+ years in pharmaceutical drug development with 5+ years in CMC project management, strong Smartsheet use, budgeting experience, and a track record of