Associate Director, Program Management

The Position:

The Associate Director - Program Management to lead cross-functional teams in the development and commercialization of diagnostic products. This individual will be accountable for the successful delivery of complex projects to ensure business objectives are met and accomplished on time, within budget, and meet operational standards. The successful candidate will oversee and manage a variety of projects across the organization, ensuring they are completed on time, within scope, and within budget. The ideal candidate brings a deep understanding of product development under ISO13485, global regulatory pathways (e.g., EU IVDR, US FDA, etc.), and lifecycle management, along with strong leadership and communication skills to influence and guide teams in a fast-paced, regulated environment.  

 This is a hybrid position based in our South San Francisco, CA office. Based on candidate location, we may consider remote. 

Key Responsibilities:  

• Lead end-to-end project management of diagnostic development programs, from feasibility through development, verification/validation, regulatory submission, and commercialization. 
• Drive cross-functional core teams (e.g., R&D, QA/RA, Clinical Affairs, Manufacturing, Supply Chain, Commercial) to achieve program milestones on time, within scope, and on budget. 
• Serve as a leader for assigned programs/projects with a high level of comfort in leading others including senior level personnel. 
• Develop and maintain integrated project plans, timelines, risk registers, and mitigation strategies. 
• Partner closely with regulatory and quality teams to align project activities with global regulatory pathways and regulations (e.g., IVDR, US FDA 510k, PMA, etc.) and quality management system requirements (e.g., ISO 13485, MDSAP, US FDA 21 CFR 820). 
• Prepare and present project status, risks, and strategic recommendations to governance committees and executive leadership. 
• Foster a culture of accountability, collaboration, and continuous improvement across teams and stakeholders. 
• Provide mentorship and leadership to junior project managers and contribute to the development of PMO processes and tools. 
• Identify, raise, and address issues or risks that arise as needed. 
• Identify individual project resource requirements and portfolio capacity needed. Work with functional leads to identify and assign individual project responsibilities. 
• Report regularly on project status, milestones, and KPIs to senior leadership 
• Contribute to the design and implementation of project management framework and tools. 
• Foster a culture of continuous improvement and innovation within the project management team and broader organization. 
• Work with business leaders and PMO leadership to align product / program roadmaps to goals, portfolio priorities, budgets, and resource plans. 
• Other duties as assigned. 

Who You Are:

• Minimum of 7+ years of project management experience within the IVD, diagnostics, or medical device industry. 
• Bachelor’s or master’s degree in life sciences, biotechnology, engineering, business, or related field preferred. 
• Strong working knowledge of IVD design development processes, including clinical validation, regulatory pathways (e.g., CE/IVDR, ISO 13485, 510(k), PMA), and quality systems. 
• Proficiency in project management methodologies and tools. Smartsheet knowledge and experience is preferred. 
• Excellent communication, collaboration, and leadership skills with the ability to influence at all levels of the organization  
• Ability to effectively lead people and drive results through cross-functional engagement. 
• Experience working with cross-functional teams, including Product Development, clinical, regulatory, operations, and commercial departments. 
• PMP or equivalent certification preferred. 
• You are a good business partner and a good human. 

#LI-Hybrid, or #LI-Remote