Calyxo, Inc.
Manager, Medical Affairs - Pleasanton, CA
Calyxo, Inc., Pleasanton, California, United States, 94566
Join Calyxo, Inc. to advance kidney stone treatment. Calyxo is a medical device company headquartered in Pleasanton, CA, founded in 2016 with a mission to improve patient safety through innovative devices.
Summary The Manager, Medical Affairs plays a strategic, cross‑functional leadership role within the Medical & Clinical Affairs team. The role builds and leads a high‑performing team, overseeing risk management, regulatory strategy, new product development, scientific communications, and cross‑functional alignment.
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.
Develop and implement 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 priorities, allocate resources, and set key performance indicators.
Team Leadership & Talent Development
Build, lead, and mentor a team of Medical Affairs Specialists, providing guidance, 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.
Recruit, onboard, and delegate responsibilities effectively while maintaining oversight of critical deliverables and quality standards.
Medical Governance & Risk Management
Oversee strategic direction for complex risk management initiatives, including patient safety evaluations, HHEs, and medical harm stratification.
Lead patient complaint and incident investigation strategy, ensuring proper determination of severity and root cause.
Provide oversight of the external HCP safety committee, enabling timely action on safety concerns.
Develop and implement risk management frameworks, SOPs, and quality metrics to enhance patient safety oversight.
Scientific Communications & Medical Writing
Oversee development of high‑quality, strategic medical content including CERs, regulatory submissions, clinical summaries, white papers, and RFAI responses.
Lead standardization, continuous improvement, and quality oversight of medical response templates and adverse event rate derivation.
Manage review process for marketing communication promotional content and other materials.
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.
Direct literature surveillance and competitive intelligence programs.
Manage the process for medical information requests.
Build relationships with key external stakeholders, including healthcare providers and safety consultants.
Process Innovation & Operational Excellence
Identify organizational gaps and lead implementation of improvements to advance the maturity of Medical Affairs systems.
Drive departmental initiatives with strategic vision, navigating ambiguity and prioritizing high‑impact outcomes.
Establish and track KPIs to measure team effectiveness, quality metrics, and operational efficiency.
Champion 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.
Optimize resource utilization and operational efficiency across the function.
Who You Will Report To
Vice President, Medical & Clinical Affairs
Requirements
Advanced clinical degree (MD, PharmD, NP, PA, RN or equivalent) with 5‑7 years of experience in Medical Affairs or a closely related function.
Minimum 3 years of people management or team leadership experience.
Proven track record of strategic leadership, cross‑functional collaboration, and influencing organizational outcomes.
Strong communication skills with ability to engage executives, cross‑functional teams, and external healthcare providers.
Strong clinical decision‑making with measurable impact.
Adaptable, welcoming of change, and skilled in process improvement.
Advanced organizational, time management, and project management skills.
Proficiency with Microsoft Office Suite; Excel for PMCF analyses required.
Medical writing experience inclusive of assessments, abstracts, summaries, and regulatory submissions.
Experience with FDA and medical device regulations (ISO, MDR).
Experience with budget management and resource planning preferred.
Hybrid work model: minimum 3 days in the office.
Travel up to 10%.
Full‑time employment.
What We Offer
A competitive base salary of $155,000–$190,000 with variable incentive plan.
Stock options – ownership and a stake in a mission‑driven company.
Comprehensive benefits package including 401(k), health insurance, and paid vacation.
EEO Statement Calyxo is an equal‑opportunity employer. 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 characteristic.
Legal Authorization Legal authorization to work in the United States is required. All persons hired will be required to verify their identity and eligibility to work in the U.S. and complete the required employment eligibility verification upon hire.
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Summary The Manager, Medical Affairs plays a strategic, cross‑functional leadership role within the Medical & Clinical Affairs team. The role builds and leads a high‑performing team, overseeing risk management, regulatory strategy, new product development, scientific communications, and cross‑functional alignment.
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.
Develop and implement 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 priorities, allocate resources, and set key performance indicators.
Team Leadership & Talent Development
Build, lead, and mentor a team of Medical Affairs Specialists, providing guidance, 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.
Recruit, onboard, and delegate responsibilities effectively while maintaining oversight of critical deliverables and quality standards.
Medical Governance & Risk Management
Oversee strategic direction for complex risk management initiatives, including patient safety evaluations, HHEs, and medical harm stratification.
Lead patient complaint and incident investigation strategy, ensuring proper determination of severity and root cause.
Provide oversight of the external HCP safety committee, enabling timely action on safety concerns.
Develop and implement risk management frameworks, SOPs, and quality metrics to enhance patient safety oversight.
Scientific Communications & Medical Writing
Oversee development of high‑quality, strategic medical content including CERs, regulatory submissions, clinical summaries, white papers, and RFAI responses.
Lead standardization, continuous improvement, and quality oversight of medical response templates and adverse event rate derivation.
Manage review process for marketing communication promotional content and other materials.
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.
Direct literature surveillance and competitive intelligence programs.
Manage the process for medical information requests.
Build relationships with key external stakeholders, including healthcare providers and safety consultants.
Process Innovation & Operational Excellence
Identify organizational gaps and lead implementation of improvements to advance the maturity of Medical Affairs systems.
Drive departmental initiatives with strategic vision, navigating ambiguity and prioritizing high‑impact outcomes.
Establish and track KPIs to measure team effectiveness, quality metrics, and operational efficiency.
Champion 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.
Optimize resource utilization and operational efficiency across the function.
Who You Will Report To
Vice President, Medical & Clinical Affairs
Requirements
Advanced clinical degree (MD, PharmD, NP, PA, RN or equivalent) with 5‑7 years of experience in Medical Affairs or a closely related function.
Minimum 3 years of people management or team leadership experience.
Proven track record of strategic leadership, cross‑functional collaboration, and influencing organizational outcomes.
Strong communication skills with ability to engage executives, cross‑functional teams, and external healthcare providers.
Strong clinical decision‑making with measurable impact.
Adaptable, welcoming of change, and skilled in process improvement.
Advanced organizational, time management, and project management skills.
Proficiency with Microsoft Office Suite; Excel for PMCF analyses required.
Medical writing experience inclusive of assessments, abstracts, summaries, and regulatory submissions.
Experience with FDA and medical device regulations (ISO, MDR).
Experience with budget management and resource planning preferred.
Hybrid work model: minimum 3 days in the office.
Travel up to 10%.
Full‑time employment.
What We Offer
A competitive base salary of $155,000–$190,000 with variable incentive plan.
Stock options – ownership and a stake in a mission‑driven company.
Comprehensive benefits package including 401(k), health insurance, and paid vacation.
EEO Statement Calyxo is an equal‑opportunity employer. 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 characteristic.
Legal Authorization Legal authorization to work in the United States is required. All persons hired will be required to verify their identity and eligibility to work in the U.S. and complete the required employment eligibility verification upon hire.
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