Scientist, Scientific Affairs - Pleasanton, CA

Calyxo

17h • $120,000 - $140,000 • Onsite

About The Position

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.

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, including peer-reviewed publications, abstracts, and scientific presentations
• Demonstrated ability to interact with industry professionals and KOLs
• Strong strategic thinking and interpersonal skills with the ability to work in a fast-paced, dynamic start-up environment
• Exceptional written and verbal communication skills, with the ability to translate complex scientific data into clear, concise messaging for diverse audiences
• Ability to work independently with sound autonomous decision making
• Legal authorization to work in the United States is required

Nice To Haves

• Experience managing clinical pipelines, regulatory submissions, and R&D projects a plus
• Experience in competitive intelligence and interpreting market trends a plus

Responsibilities

• 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
• 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
• 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
• Provide medical writing for all FDA submissions
• Write Clinical Evaluation Reports (CERs); oversee accompanying comprehensive literature review
• 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
• 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
• 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
• 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
• Compliance with relevant county, state, and Federal rules regarding vaccinations

Benefits

• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree