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Calyxo, Inc. · 4 hours ago

Manager, Scientific Affairs- Pleasanton, CA

Pleasanton, CA

Full-time

Onsite

Mid, Senior Level

$145K/yr - $165K/yr

3+ years exp

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, focused on improving kidney stone treatment. The Manager of Scientific Affairs will oversee strategic management of scientific communications, publication planning, KOL engagement, and pre-clinical evidence generation, requiring collaboration across multiple departments to drive impactful outcomes.

Health CareMedicalMedical DeviceWellness

Responsibilities

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

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

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

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

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

Qualification

PhD in relevant fieldBiostatistical trainingScientific communicationClinical research experienceUrology/nephrology experiencePublication managementProject managementInterpersonal skillsWritten communicationVerbal communicationStrategic thinkingTeam collaboration

Required

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

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

Legal authorization to work in the United States is required

Preferred

PhD preferred with proven biostatistical training and application in a relevant scientific discipline (e.g., Life Sciences, Pharmaceutical Sciences, Clinical Research, or similar fields)