Staff Program Manager - Product Development (Clinical/CDx) Remote Potential

Responsibilities:

• Provides management and leadership skills to drive execution on project goals
• Collaborate cross-functionally to create, execute and communicate overall project plans (scope, schedule, resourcing, quality, risk management, budget, and procurement) and revise them appropriately to meet changing project needs and requirements
• Identify needs for changes to plan and communicate them to the team and stakeholders to ensure program goals are in alignment with business objectives
• Schedule and lead phase gate reviews with an executive approval committee
• Identify, resolve and escalate program issues, facilitate tradeoff decisions, and remove obstacles
• Ensure product development efforts adhere to internal processes and design control standards
• Continuously analyze and manage risks to enable successful project completion
• Define and optimize project management and development processes, methodologies, and tools to improve organizational efficiency and effectiveness
• Apply best practices and knowledge of internal/external business challenges to improve products
• Contribute to product development process or PMO functional improvement initiatives

Experience\Knowledge Requirements:

• Experienced in program managing full cross-functional new product development Core Teams as the primary program manager for the project, resulting in the launch of IVD and/or highly complex RUO products/platforms
• Familiar with FDA and CE-IVD regulated product development processes and design controls, preferably in Next-Gen Sequencing and/or Oncology
• Familiar with Pharmaceutical or CDx development lifecycles and regulatory requirements
• Expert at project scheduling of new product development phase gate projects using MS Project, including dependencies and critical path determination and optimization
• Able to develop project plans, communicate proposals to leadership, and manage scope across the phases of the project.
• Finance/Business Experience: Experienced in resource planning, resource management, and managing/delivering to project budgets. Ability to lead a project team to meet business commitments, objectives, and support strategic goals.
• Ability to identify key issues, motivate and empower others to address them in a way which builds morale and generates ownership and commitment
• Experienced in applying basic principles of Six Sigma. Recommends best practices to improve products, processes, or services.
• Familiarity with most topics in the PM Body Of Knowledge (PMBOK)
• Excellent written and verbal communication skills with the ability to present complex information in a clear and concise manner to all levels of the organization and to transparently deliver difficult messages
• Experienced in managing projects with external partners or customers
• Familiarity with molecular assay development, genetic sequencing principles or sequencing devices, preferred
• Ability to effectively lead virtual, global teams, and mentor more junior team members

Education Requirements:

• Bachelors degree and a minimum of 8 years of product development experience with 4 years managing projects, or equivalent. Experience in a regulated industry is desired.
• PMP certification, preferred