Medical Affairs Specialist - 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 Medical Affairs Specialist plays a strategic cross-functional 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 and clinical judgment to help drive and support critical initiatives spanning risk management regulatory strategy new product development scientific communications and cross-functional alignment. The successful candidate will be a self-starter with a proactive mindset capable of shaping and executing scalable processes that elevate Medical Affairs as a strategic partner in achieving corporate goals.

In This Role You Will:

• Strategic Leadership & Cross-Functional Influence
  • Serve as a strategic partner across Clinical Regulatory R&D and Commercial functions to align medical strategy with organizational goals
  • Facilitate the development and implementation of scalable efficient processes that elevate Medical Affairs operational and strategic roles
• Medical Governance & Risk Management
  • From a Medical Affairs perspective lead complex risk management initiatives including patient safety evaluations health hazard evaluations (HHEs) and medical harm stratification with autonomy and sound clinical judgment
  • Strategically guide patient complaints and incident investigations with the goal of determining severity relatedness and root cause in alignment with FDA regulations; and produce all medical assessments
  • Oversee the external HCP safety committee whose primary objective is to help identify and recommend actions on newly emerging safety concerns associated with complaints received during post-market surveillance; and support training as needed
• Scientific Communications & Medical Writing
  • Contribute to the development of high-quality strategic medical content including but not limited to Clinical Evaluation Reports (CERs) regulatory submissions clinical summaries white papers and requests for additional information (RFAI) from regulatory bodies
  • Lead the standardization and continuous improvement of medical response templates or assessments; and derive adverse event rates from the post market clinical follow up (PMCF)
  • Participate in the review of marketing communication promotional content and other materials working internally and cross-functionally to ensure materials are processed completely and are based on accurate interpretation of clinical practice and data
• Medical Information & External Engagement
  • Manage off-label inquiries and ensure compliance with FDA regulations while facilitating cross-functional awareness and education
  • Lead literature surveillance and competitive intelligence gathering (in conjunction with scientific affairs and marketing) to proactively inform strategic decision-making and clinical differentiation
  • Oversee requests for medical information utilizing appropriate cross-functional input to create and standardize responses
• Process Innovation & Operational Excellence
  • Identify gaps design solutions and implement improvements to advance the maturity of Medical Affairs systems metrics and management tools
  • Drive forward new initiatives with minimal oversight navigating ambiguity and prioritizing impact
• Other duties as assigned

Who You Will Report To:

• See Organizational Chart

Requirements:

• Advanced clinical degree (MD PharmD NP PA RN or equivalent) with at least 5 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
• Strong communication skills with the ability to respond to verbal and written inquiries from all levels including executives cross-functional team members and healthcare providers
• Sound clinical decision-making with expected examples of successful implementation
• Strong interpersonal and relationship building skills with an expectation to lead by influence
• Adaptable and welcoming of change and willingness to explore and implement process improvements
• Advanced organizational and time management skills with proven ability to drive initiatives forward successfully; formal experience in project management a plus
• Demonstrated success leading autonomous projects and developing strategic solutions within a dynamic fast-paced environment
• Proficiency with Microsoft Office Suite Teams SharePoint and OneNote. Use of Microsoft Excel for PMCF analyses will be required.
• Understanding of statistics as it relates to clinical studies and interpretation of medical literature
• Medical writing inclusive of medical assessments abstracts clinical summaries and presentations
• Skills in complex analytic problem solving; ability to recognize potential obstacles and work to resolve them within set timelines
• Expertise in scientific and research methodology medical device regulations and guidelines
• 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 FDAs 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 $130000 - $150000 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 onlyvalued but alsoprioritized. 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 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. If you receive a request for information from any other domain please contact us directly at 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.