Manager 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.

Summary:

This leadership role within Medical and Clinical Affairs is responsible for strategic management of Scientific Affairs activities including scientific communications, publication and podium planning, KOL engagement and pre-clinical evidence generation. The role requires cross-functional collaboration with Clinical Operations, Marketing, R&D, Sales, and Regulatory to drive impactful outcomes. The ideal candidate will have a deep understanding of scientific research and clinical development and will oversee medical writing, as well as biostatistical support for all scientific affairs research engagements. This position requires strong communication skills and the ability to lead and support a fast-paced, dynamic team

In This Role, You Will:

• Scientific Communication

• Develop project management tools that clearly demonstrate scientific communication plans (i.e., publication and podium plans)

• Manage the development and submission of high-quality peer-reviewed publications, abstracts and presentations by overseeing medical writing. Directly write, edit, and analyze data as needed

• Manage biostatistics and programming requests required for all scientific communication deliverables

• Own relationships with investigators / authors of publications, abstracts and presentations. This includes administrative oversight of HCP engagements, contracts and payments

• In-person support of KOL presentations at meetings as requested

• Pre-clinical and Clinical Research

• Support trial design, protocol development and statistical analysis plans by deploying available resources

• Organize and/or lead meetings with clinical operations, clinical development engineering and R&D ensuring evidence generation is aligned with major urology meetings. Elevate risks as they emerge

• Assist with and eventually lead strategic evaluation of pre-clinical investigator-initiated studies

• Marketing Initiatives

• Translate scientific data for the commercial team and ensure marketing messages are fair and balanced

• Distill scientific evidence that will be presented at urology meetings focusing on SURE/CVAC and relevant competitors. Assist with organizing meeting coverage

• Support medical communications review, train medical writers on content review

• Regulatory and Reimbursement Initiatives

• Oversee medical writing and literature reviews for all FDA submissions and Clinical Evaluation Reports (CERs) as requested by deploying available resources

• Manage healthcare claims analysis including benchmark research and vendor identification

• Organize meetings or liaise with the market access team to ensure evidence generation and publication plans meet foreseeable needs

• 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:

• Vice President, Medical & Clinical Affairs

Requirements:

• PhD preferred 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 years of experience in scientific affairs or clinical research within the biotech industry. Direct experience in urology or nephrology required

• Strong publication record required with at least 2 first author publications and multiple first author research abstracts submitted to society meetings. Please include publication record as part of your resume or CV

• Demonstrated ability and past experience interacting with urologists and/or endourologists

• Experience having direct reports, teaching or overseeing graduate or undergraduate students required

• Management of various research related projects including but not limited to clinical pipeline deliverables, regulatory submissions, pre-clinical experimentation, competitive intelligence gathering and databased analyses

• 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

• Work location: Pleasanton, CA.

• Travel: Up to 25%

• Full-time employment

• Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, and all other international regulatory requirements with which the company complies

• 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 range of $140,000 - $155,000 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 only valued, but 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 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.

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 firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com 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.