Scientist, Scientific 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. Summary: The Scientist, Scientific Affairs is an integral member of the Medical and Clinical Affairs team and will lead and/or participate in several dynamic workstreams 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. In this role, you will have responsibilities in these areas: • 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 activities as assigned by supervisor Who You Will Report To: • Director, Scientific Affairs Requirements: • Advanced degree, such as a PhD or MD with proven biostatistical training and application, in a relevant scientific discipline (e.g., Life Sciences, Pharmaceutical Sciences, Clinical Research, or similar fields) • Minimum of 3.5 to 5 years of experience in scientific affairs, clinical research, or drug development within the pharmaceutical or biotech industry, preferably in urology, nephrology, or related fields • Strong publication record required with at least 1 first author publication. Please include publication record as part of your resume or CV • Proven experience in scientific communications...