Medical Affairs Specialist

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.

The Medical Affairs Specialist is an integral member of the Medical and Clinical Affairs team and will lead and participate in several dynamic workstreams. The role will enable you to utilize and grow your skills in multi-project management, on-going development, and improvement of processes, building strong internal relationships and representing Medical Affairs in activities driven by other departments. This work will rely on your skills in clinical decision-making, project management, medical writing, and process improvement methods. We are looking for someone with a clear understanding of healthcare delivery, and an interest in exposure to scientific affairs, clinical operations, regulatory requirements; strong, collaborative and communication skills and the ability to perform independently in a fast-paced, dynamic environment.

In This Role, You Will:

• Cross-functional risk management activities, including but not limited to
  
  
  
  • Support patient safety evaluations
  • Documentation of risk/harm stratifications
  • Management of health hazard evaluations (HHEs) and other risk assessments
  • Review of risk document updates
  
  
  
  
• Complaint medical assessment, narrative writing, and other complaint processing activities for clinical studies and post market surveillance
  
  
  
  • Develop, implement, and improve templates and standardization of processes for reportable event follow-up and regulatory submissions
  
  
  
  
• Clinical input and medical writing support of regulatory reports, i.e., Clinical Evaluation Reports (CERs), regulatory submissions, formal requests for additional information (RFAIs)
• Manage requests for medical information, utilizing appropriate cross-functional input to create and standardize responses
• Participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data
• Medical input and content expertise, implemented in the following areas:
  
  
  
  • Performance of comprehensive literature searches to inform clinical decision-making and competitive benchmarking
  • Development of clinical summaries, white papers or responsive documents
  • Inform and guide support of clinical, R&D, and marketing initiatives
  • Support of external and internal training
  
  
  
  
• Off-label program, including but not limited to
  
  
  
  • Documentation of off label inquiries and responses including quarterly and annual reports as requested
  • Creation of standard response letters in adherence with FDA guidance
  • Knowledge of FDA procedures guiding off label policy
  
  
  
  
• Perform other duties as assigned

Who You Will Report To:

• Director, Scientific Affairs

Requirements:

• MD, PhD, NP, PA, PharmD, RN, LPN/LVN or equivalent practical experience with at least 5 years of experience in or combination of experience in clinical care, medical device, biotech, hospital administration or pharmaceutical industry
• Strong communication skills with the ability to respond to verbal and written inquiries at all levels including executives, 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; experience in project management to drive initiatives forward successfully
• Intermediate level of comfort with Microsoft Office, (including strong experience Excel) Teams/Sharepoint, OneNote, etc.
• 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
• Travel: Up to 10%
• Full time employment
• Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which the company complies.
• Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• 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 a compensation plan as follows:

• Competitive base salary of $120,000 - $140,000
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

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.