Senior Clinical Project Manager

Summary

Join our team as a Senior Clinical Project Manager (Contract) at Day One Biopharmaceuticals. We're seeking a creative, resourceful, and integrative thinker to oversee and deliver complex projects for Development Operations.

Requirements

• BS/BA in physical science, Communication, Nursing or technical field (such as chemistry, engineering, biology, mathematics)
• 10+ years project management experience with focus in pharmaceutical or biotechnology industry
• Extensive experience in leading complex, cross-functional projects or programs with expertise in R&D and understanding of manufacturing, materials management, procurement, supply chain, quality, and regulatory affairs
• Ability to apply a wide range of disciplines, including business requirements analysis, project planning, scheduling, cost control, and economic analysis, to manage projects and programs effectively
• Demonstrated time management skills, particularly in calendar management and goal setting
• Proficient in MS Office tools (PowerPoint, Word, Excel, Project, Visio) and other project management software such as SmartSheets
• Well-versed in governmental regulations, including FDA, EMA, MHRA regulations

Responsibilities

• Manage and support multiple projects' priorities, dependencies, scope, risks, and project resources
• Build integrated timelines across trials and functions to exhibit deliverables, competing priorities, major milestones
• Collaborate with DevOps for CRO delivery discussion regarding timelime, cost and delivery per the contract
• Lead program and project reviews, fulfilling reporting requirements
• Collaborate with cross-functional teams to assess risks, define scope and budget, and develop project schedules and plans
• Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
• Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline
• Build and maintain project management documents such as project plan, RAID (risks, actions, issues, and decisions) log, charter, and communications plan
• Ownership and support of SharePoint, Slack channels, Smartsheet, and other communication & tracking systems
• Communicate and report project updates to stakeholders and risk escalations to leadership team
• Ensure projects adhere to portfolio flow, and documentation and gate criteria meet project management standards
• Foster a collaborative and high-performing project team environment, providing guidance, support, and mentorship to team members
• Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations
• Promote effective communication and teamwork among project members

Preferred Qualifications

• Strong knowledge of regulatory requirements
• Certification as a Project Management Professional by the Project Management Institute (PMI)