Manager, Scientific Affairs- Pleasanton, CA

Calyxo • Pleasanton, CA

12h • $145,000 - $165,000 • 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:
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

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
• 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.

Responsibilities

• 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
• 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.

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: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees