Program Manager - Product Development; Clinical​/CDx Remote Potential

Job Openings 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 escape 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 nowledge 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 life cycles 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.