Senior Program Manager, R&D - Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

The Sr. Program Manager is responsible for providing overall project and program management support to commercial product development projects. This role interacts with all levels throughout the organization. This position also directly interacts with cross-functional project team members.   

In This Role, You Will: 

• Initiate and set project and roadmap goals for assigned program(s) according to the strategic objectives of the organization.  
• Plan assigned program(s) from start to completion involving deadlines, milestones and processes.  
• Develop, maintain and track detailed project and/or program timelines that feed into an integrated project plan. Report out program/project status to Senior Management using dashboards and other tools.   
• Coordinate and schedule regular cadence of project team meetings and facilitate discussion and conflict resolution as needed.  
• Identify assumptions, risks, mitigations, key deliverables and milestones, critical path dependencies and resource needs. Work with technical managers and team leads to resolve blockers.   
• Work with Product Development leads to develop program budgets and resourcing plans.  
• Devise evaluation strategies to monitor on-time project performance and determine the need for improvements.  
• Supervise project managers involved to provide feedback and resolve complex problems.  
• Discover ways to enhance the efficiency and productivity of procedures and people.  
• Apply change, risk, and resource management principles when needed.  
• Ensure program operations and activities adhere to legal and regulatory guidelines and follow internal policies.  
• Ensure the Design History File is complete, accurate, and stored appropriately.   
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.  
•  Actively promote and support the company’s Management Review process.    

Who You Will Report To: 

Sr. Vice President of Research and Development 

Requirements: 

• 8+ years of project management experience at the Senior Program Manager level in the biotech, pharmaceutical or medical device industries. Experience in full-cycle product life cycle management is required.   
• 12+ years of relevant work experience with demonstrably increasing work responsibilities  
• Bachelor’s or Master’s degree in an engineering discipline is required.   
• Thorough understanding of project/program management techniques and methods. Project Management certification is strongly desired.   
• Extensive knowledge of project tracking tools, dashboards as well as performance evaluation techniques. 
• Expertise in working in a highly regulated environment and the associated procedures and processes according to Good Manufacturing Practices, and applicable FDA and International Regulatory requirements.  
• Start-up experience preferred.   

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

We also offer a compensation plan as follows: 

• Competitive base salary range of $152,000 - $182,000
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid time off 

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. 
 
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.