Manager, Medical Affairs - 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.

Summary:

The Manager, Medical Affairs plays a strategic, cross-functional leadership role within the Medical & Clinical Affairs team. With an emphasis on enhancing the value, visibility, and impact of the Medical Affairs function, the role operates to maintain patient safety at the forefront, advocating for the well-being of patients while maintaining the integrity of healthcare practices. This role demands autonomy, strategic thinking, strong clinical judgment, and people leadership to drive and support critical initiatives spanning risk management, regulatory strategy, new product development, scientific communications, and cross-functional alignment. The Manager, Medical Affairs will build and lead a team of Medical Affairs professionals, providing mentorship, oversight, and strategic direction while serving as a key partner to senior leadership. The successful candidate will be a proven leader with a proactive mindset, capable of building and scaling processes, developing talent, and elevating Medical Affairs as a strategic partner in achieving corporate goals.

In This Role, You Will:

Leadership & Cross-Functional Influence

• Serve as a leader and partner across Clinical, Regulatory, R&D, and Commercial functions to align medical strategy with organizational goals and business priorities
• Lead the development and implementation of scalable, efficient processes and operational frameworks that elevate Medical Affairs' strategic impact
• Represent Medical Affairs in cross-functional leadership forums and contribute to departmental strategic planning
• Partner with senior leadership to define Medical Affairs priorities, resource allocation, and key performance indicators

Team Leadership & Talent Development

• Build, lead, and mentor a team of Medical Affairs Specialists, providing guidance, professional development, and performance management
• Establish team goals, objectives, and individual development plans aligned with departmental and corporate priorities
• Foster a culture of excellence, collaboration, continuous learning, and accountability within the Medical Affairs team
• Recruit and onboard new team members as the organization scales. Delegate responsibilities effectively while maintaining oversight of critical deliverables and quality standards

Medical Governance & Risk Management

• Oversee and provide strategic direction for complex risk management initiatives, including patient safety evaluations, health hazard evaluations (HHEs), and medical harm stratification with clinical judgment and regulatory expertise
• Lead and manage the strategic approach to patient complaints and incident investigations, ensuring proper determination of severity, relatedness, and root cause in alignment with FDA regulations; conduct or oversee writing of all medical assessments
• Provide oversight of the external HCP safety committee, ensuring effective identification and action on emerging safety concerns; lead strategic decision-making and ensure adequate training and preparedness
• Develop and implement risk management frameworks, SOPs, and quality metrics to enhance patient safety oversight

Scientific Communications & Medical Writing

• Oversee the development of high-quality, strategic medical content including but not limited to Clinical Evaluation Reports (CERs), regulatory submissions, clinical summaries, white papers, and responses to requests for additional information (RFAI) from regulatory bodies
• Lead the standardization, continuous improvement, and quality oversight of medical response templates, assessments, and adverse event rate derivation from post-market clinical follow-up (PMCF)
• Manage the review process for marketing communication promotional content and other materials, ensuring cross-functional collaboration, completeness, and accurate interpretation of clinical practice and data
• Ensure consistency, scientific rigor, and regulatory compliance across all Medical Affairs communications

Medical Information & External Engagement