Manager, Medical Affairs - Pleasanton, CACalyxo • Pleasanton, CA, US
Manager, Medical Affairs - Pleasanton, CA
Calyxo • Pleasanton, CA, US
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job_description.job_card.job_descriptionBuild, 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 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 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 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 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 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 Vice President, Medical & Clinical Affairs 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
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.
Manager, Medical Affairs
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
Medical Governance & Risk Management
Scientific Communications & Medical Writing
Medical Information & External Engagement
Process Innovation & Operational Excellence
Budget and Resource Management
Who You Will Report To :
Requirements :
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
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Manager Pleasanton • Pleasanton, CA, US
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