Cross-Functional Plan Management

• Partner with functional leads (including Clinical, Regulatory, CMC, Quality, Commercial, Medical Affairs) to ensure functional project plans are complete, accurate, and interconnected.
• Validate that key interdependencies, risks, and critical path items are captured and reflected in the enterprise integrated plan.
• Drive proactive discussion around trade-offs, resourcing, risk mitigation and contingency planning

Enterprise Integrated Plan

• Maintain the master integrated plan covering pivotal Phase 3 execution, BLA submission, and incorporating U.S. launch readiness.
• Provide ongoing visibility into progress, risks, and scenario updates for leadership.
• Highlight bottlenecks and ensure timely escalation/resolution.
• Work with functional leaders and the Head of Operation to define KPI, Critical Path, On-Time measures, organizing this in support of the Core team. 

Execution & Communication

• Facilitate cross-functional working team meetings; capture and track decisions, risks, and action items.
• Translate complex program status into clear updates for senior leadership and governance forums.
• Ensure consistency and transparency of planning data across all stakeholders

Tools & Systems

• Build and manage Smartsheet-based timelines, dashboards, and automated reports.
• Act as a subject-matter resource for Smartsheet use and integration across function

QUALIFICATIONS

Education & Experience

• Bachelor’s degree required; advanced degree in Life Sciences, Business, or related field preferred.
• 7+ years of project/program management experience in biotech or pharma, with working knowledge of Phase 3 to pre-commercial readiness.
• Strong understanding of core functional content areas including Clinical Development, Regulatory, CMC, Commercial, and Medical Affairs.
• Experience supporting BLA/NDA submissions and/or product launches strongly preferred.

Skills & Competencies

• Advanced Smartsheet expertise (required).
• Demonstrated experience in project and or program management. Project Management certifications encouraged.
• Strong ability to synthesize information across multiple functions into an integrated view.
• Proven skill in managing interdependencies and communicating trade-offs.
• Excellent written and verbal communication skills; able to engage both working teams and senior executives.
• Highly organized, detail-oriented, and able to manage competing priorities in a fast-paced environment.
• Ability to integrate in to an agile organization