Scientist, Scientific 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.

The Scientist, Scientific Affairs is an integral member of the Medical and Clinical Affairs team and will lead and/or participate in several dynamic work streams including but not limited to scientific communication strategy, support of clinical and R&D initiatives, regulatory submissions and marketing priorities. The ideal candidate will have a deep understanding of scientific research, clinical development, and market dynamics in the field of urology.

This position requires a highly collaborative team member who will work cross-functionally with R&D, regulatory, legal, clinical operations, and marketing. Excellent communication skills and the ability to perform independently in a fast-paced, dynamic environment are essential.

• Scientific Communication
  • Implementation and project management of the company's scientific podium and publication plan with expected contribution to strategy
  • Creation and timely submission of high-quality peer-reviewed publications, abstracts and presentations covering all categories listed below
  • Build relationships with key opinion leaders (KOLs) to foster research collaborations and ensure timely abstract and publication submissions. In-person support of all KOL presentations at meetings is required
  • Development of deliverables including but not limited to white papers, op eds, and clinical summaries
• Clinical Pipeline Initiatives
  • Collaborate with clinical operations to support trial design, develop protocols, and ensure clinical data supports the company's scientific objectives
  • Foster communication and alignment with clinical operations and other stakeholders to ensure trial execution is aligned with podium and publication plans. Work cross functionally to adjust timelines if/when milestones may be at risk elevating to leadership as needed
• R&D Projects
  • Support R&D teams and external partners to ensure scientific rigor in the development of preclinical research to clinical trials
  • Project management of the company's preclinical research strategy, inclusive of adjoining communication plan, with expected contribution to strategy
• Regulatory Submissions
  • Provide medical writing for all FDA submissions
  • Write Clinical Evaluation Reports (CERs); oversee accompanying comprehensive literature review
• Marketing Initiatives
  • Collaborate with the marketing team to translate scientific data into compelling marketing messages and develop scientific content for promotional materials as needed
  • Support medical communications review by ensuring that all marketing materials are scientifically accurate and compliant with regulations
  • Support the scientific analysis of competitive landscape, identifying trends, emerging technologies, and potential threats in the urinary stone market
• Reimbursement and health economic initiatives
  • Project management of the company's health economics outcomes research strategy, inclusive of adjoining communication plan, with expected contribution to strategy
  • In-depth participation of healthcare claims analyses including benchmark research and vendor identification
  • Continuously liaise with the reimbursement team to ensure clinical pipeline and outcomes meet foreseeable needs; align podium and publication plan accordingly
• Other requirements
  • Attend in-person team building events and contribute meaningfully
  • Attend society meetings as requested to ensure a successful podium plan and seek out immersive research presentations
  • Contribute to a culture of innovation, collaboration and scientific excellence
  • Perform additional…