Manager, Medical Affairs

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

• Oversee management of off-label inquiries and ensure team compliance with FDA regulations while facilitating cross-functional awareness and education
• Direct literature surveillance and competitive intelligence programs (in conjunction with scientific affairs and marketing) to proactively inform strategic decision-making and clinical differentiation
• Manage the process for medical information requests, ensuring utilization of appropriate cross-functional input and standardization of responses
• Build relationships with key external stakeholders, including healthcare providers, thought leaders, and safety consultants

Process Innovation & Operational Excellence

• Identify organizational gaps, design strategic solutions, and lead implementation of improvements to advance the maturity of Medical Affairs systems, metrics, and management tools
• Drive departmental initiatives with strategic vision, navigating ambiguity and prioritizing high-impact outcomes
• Establish and track key performance indicators (KPIs) to measure team effectiveness, quality metrics, and operational efficiency
• Champion the adoption of new technologies, tools, and methodologies to enhance Medical Affairs capabilities

Budget and Resource Management

• Contribute to budget planning and resource allocation for Medical Affairs activities
• Manage vendor relationships and external consultants as needed to support team objectives
• Optimize resource utilization and operational efficiency across the Medical Affairs function

Who You Will Report To:

• Vice President, Medical & Clinical Affairs

Requirements:

• Advanced clinical degree (MD, PharmD, NP, PA, RN or equivalent) with at least 5-7 years of experience in Medical Affairs or a function closely associated with patient safety and PMCF in the medical device or biopharma industry. Candidates holding a PhD will be considered on an ad hoc basis
• Minimum 3 years of people management or team leadership experience, with demonstrated success in building and developing high-performing teams
• Proven track record of strategic leadership, cross-functional collaboration, and influencing organizational outcomes
• Strong communication skills with the ability to effectively engage and influence executives, cross-functional leadership teams, and external healthcare providers
• Strong clinical decision-making with demonstrated examples of strategic implementation and measurable impact
• Strong interpersonal and relationship-building skills with proven ability to lead through influence and inspire team performance
• Adaptable and welcoming of change and willingness to explore and implement process improvements. Change management expertise with a track record of driving organizational transformation and process improvement initiatives a plus.
• Advanced organizational, time management, and project management skills with proven ability to lead multiple initiatives simultaneously; formal project management certification a plus
• Demonstrated success leading strategic projects, developing scalable solutions, and mentoring others within a dynamic, fast-paced environment
• Proficiency with Microsoft Office Suite, Teams, SharePoint and OneNote. Use of Microsoft Excel for PMCF analyses and data visualization will be required
• Understanding of statistics as it relates to clinical studies, post-market surveillance, and interpretation of medical literature
• Medical writing experience inclusive of medical assessments, abstracts, clinical summaries, presentations, and regulatory submissions
• Advanced skills in complex analytic problem solving; ability to anticipate obstacles, develop mitigation strategies, and drive resolution within set timelines
• Expertise in medical device regulations and guidelines (FDA, ISO, MDR)
• Experience with budget management and resource planning preferred
• Work location: Pleasanton, California. Hybrid (minimum 3 days in the office)
• Travel: Up to 10%
• Full-time employment
• Responsible for performing all duties in compliance with FDA's Quality System Regulation (ISO13485) and FDA Medical Device Reporting Guidance for Manufacturers as well as all other regulatory requirements with which the company complies
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
• Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings
• Compliance with relevant county, state, and Federal rules regarding vaccinations

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 an attractive compensation package, which includes:

• A competitive base salary of $155,000 - $190,000 and variable incentive plan
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

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.

Disclaimer:

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.