Director, Project Management - FSP (Client Embeded) - Remote based in the US

Thermo Fisher Scientific is a global team that values passion, innovation, and a commitment to scientific excellence. As a Project Manager Director, you will oversee the overall delivery of clinical trials, ensuring operational excellence and managing customer expectations while leading a cross-functional project team.

Responsibilities:

• Serves as the primary contact and subject matter expert between the sponsor and the organization at the project level
• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery)
• Drives and owns the strategic direction and overall delivery of the cross-functional project (time, cost, quality)
• Oversees the financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines
• Drives business by ensuring management of customer expectations to achieve optimal delivery during the project
• Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE)
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements

Requirements:

• Position requires extensive Oncology global full service clinical trial management experience
• Bachelor's degree or equivalent; preferably in medical or biological sciences or discipline associated with clinical research
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years)
• Proven clinical expertise in Oncology
• Regulatory submission experience
• Program management experience
• Strong leadership skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Sharp analytical, investigative, and problem-solving skills
• Advanced financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
• Recognized executive presence and consultation and presentation skills
• Effective critical and strategic thinking skills that accounts for a broad impact
• Excellent customer service and relationship building skills and proven ability to provide strategic input into customer management in a complex environment
• Excellent negotiation and marketing skills with ability to influence internal and external stakeholders and drive results
• Superior judgment, decision making, escalation and risk management skills
• Solution oriented with a demonstrated ability to drive innovation
• Cell Therapy study management experience, preferably in a pharma/biotech setting
• Project management certification
• Knowledge of process improvement methodology such as Lean Sigma/Change Management, certification is desirable but not mandatory
• Experience with development and implementation of digital health initiatives in clinical studies