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

Military, Veterans and Diverse Job Seekers; San Diego (CA); Remote; USD 150,000 - 210,000; Full time

Job summary

Military, Veterans and Diverse Job Seekers is seeking a Staff Program Manager for Product Development (Clinical/CDx) with remote potential. The role leads cross-functional teams, drives phase-gate reviews, and ensures compliance with design controls in regulated environments.

Strong MS Project scheduling and stakeholder communication are essential. The ideal candidate has 8+ years in product development, with experience in IVD/complex platforms, regulatory knowledge, and global virtual team

Qualifications

• 8+ years of product development experience with 4+ years in project management, in a regulated industry.
• Experience leading cross-functional NPD core teams and launching IVD/complex platforms.
• Familiarity with FDA and CE-IVD processes and design controls.
• Skilled in MS Project for scheduling, dependencies and critical path.
• Budget management experience and ability to lead a project team to commitments.
• Knowledge of PMBOK concepts and design controls in regulated settings.
• Excellent written and verbal communication for leadership audiences.
• Experience managing external partners or customers.
• Familiarity with molecular assay development concepts.

Responsibilities

• Provide leadership to drive execution on project goals.
• Collaborate cross-functionally to create and execute and communicate project plans.
• Identify needs for changes to plan and communicate them to the team and stakeholders.
• Schedule and lead phase gate reviews with an executive approval committee.
• Identify, resolve and elevate 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 processes, methodologies, and tools.
• Apply best practices to improve products and contribute to PMO initiatives.

Skills

Program management

Cross-functional collaboration

Regulatory knowledge

MS Project scheduling

Budget management

Six Sigma basics

PMBOK familiarity

Communication skills

Global virtual teams

Education

Bachelor's degree + 8+ years in product development

Tools

MS Project

Job description

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

About the job 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 elevate 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.