Clinical Project Manager

Planet Pharma is a company focused on drug development, and they are seeking a Clinical Project Manager to oversee program timelines and ensure the execution of high-quality project plans. The role involves applying project management best practices, conducting critical path analysis, and managing risks and communications across teams.

Responsibilities:

• Serve as the main steward of the PMed Team (PMT) overall program timelines, study pull-through and team efficiency by Driving the strategic planning, development and ensures execution of high quality, integrated cross-functional PMed Plans in support of the overall asset strategy & value
• Apply PM best practices in the planning, development, initiation, execution, QA/QC, and closing of projects while driving trade-off / decision making to ensure flawless execution
• Co-lead with PML content creation in preparation to cross-functional meetings, such as technical reviews (PMAF), Portal Reviews, Governance, etc
• Conduct critical path analysis (challenging assumptions, hold cross-functional team members accountable); recognize and communicate inflection points w/ mitigation strategies
• Serve as an integrator to the Evidence Generation Teams (EGTs) and Product Teams (PTs) while ensuring connectivity with (inputs to/from) Discovery Bx, platform functions and IVD/Dx activities
• Drive risk management and effective communication plans, to include asset-wide impacts
• Ensure on time delivery; drive adherence to plan (time, budget and scope); challenge delays with why not and propose mitigations; quickly escalate changes to plan
• Applying best practice project management methodology aligned with global commercialization process
• Ability to lead Agile teams and pivot quickly with changes in scientific or strategic assumptions based on internal / external data impacting the program
• Meeting effectiveness, MS Teams/Smartsheet maintenance, proper and timely escalation of issues to PMed TAHs

Requirements:

• Clinical Program Management experience
• Clinical trial operations experience
• Scientific/drug development experience
• PhD and/or Masters degree and 2 years of relevant PM experience OR
• Bachelors degree and 4 years of relevant PM experience OR
• Associates degree and 6 years of relevant PM experience
• Technical / scientific background with 6+ years industry and/or academic experience
• Prior pharma / consulting and/or drug development experience including deep experience in one or more core drug development and commercialization functions and experience leading teams through governance processes
• Development experience ideally incl. a program that involved one or more of the following: Research, early or late development; Diagnostics; novel biomarkers; Computational Biology; RWE
• Program and project management skills with experience in a healthcare-related environment, operationalizing strategic initiatives, including cross-functional strategic planning, development of integrated plans, monitoring and driving execution to plan
• Emotional intelligence skills including influencing without authority and navigating within a matrix environment
• Experience using Project Management and AI/ML tools, methodologies, practices and infrastructure, as related to the Biopharmaceutical Industry
• Highly experienced on MS Suite tools (PowerPoint, Excel, etc.) and project management software such as Smartsheet, Planisware, SharePoint, etc
• Finance and budget management experience
• Business process and systems management, Project planning and management (PMP preferred)
• Knowledge of SOPs, good clinical practices and regulatory requirements
• Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment
• Exceptional leadership and team management skills
• Experience on late research and early development projects
• Exposure to one or more of the following TAs: Rare Disease; CV/Metabolic; and/or Obesity