Director Of Scientific Affairs - Pleasanton, CA

About this Position: 

The Director of Scientific Affairs will play a pivotal role in shaping the scientific communication strategy, supporting clinical and R&D pipeline initiatives, and contributing to the company’s regulatory and marketing strategies. 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 leader who will work cross-functionally with R&D, regulatory, legal, clinical operations, marketing, and senior management teams.

Key Responsibilities:

• Scientific Communication Strategy
• Lead the development and execution of the company’s scientific communication strategy, ensuring alignment with overall business goals.
• Oversee the creation and submission of high-quality peer-reviewed publications, white papers, opinion editorials, abstracts, and scientific presentations for national and international meetings.
• Develop and maintain relationships with key opinion leaders (KOLs), academic institutions, and scientific organizations to foster collaborative research opportunities.
• Ensure that scientific content effectively communicates the company’s research, clinical trials, and innovative treatments to both scientific and non-scientific audiences.
• Strategic Scientific and Clinical Planning
• Partner with the leadership team to develop long-term scientific and clinical strategies that align with the company’s vision for growth and market leadership.
• Ensure the scientific strategy is forward-looking, anticipating changes in the market, clinical guidelines, and regulatory environment.
• Identify new opportunities for strategic partnerships, collaborations, and licensing agreements that will drive the company’s scientific objectives.
• Clinical Pipeline Initiatives
• Lead strategic planning for clinical trials and clinical development programs related to urinary stone treatments.
• Work closely with clinical operations to ensure that clinical trials are executed effectively, meeting timelines, regulatory requirements, and budget.
• Collaborate with clinical teams to design clinical trials, develop protocols, and ensure clinical data supports future product development.
• R&D Projects
• Support the company’s R&D pipeline, ensuring alignment with scientific goals and market needs.
• Facilitate scientific innovation by identifying new opportunities for research and development within the urinary stone treatment space.
• Support R&D teams and external partners to ensure scientific rigor in the development of new products, from preclinical research to clinical trials.
• Support R&D from a clinical and scientific perspective with respect to risk management and analysis
• Regulatory Submissions and Product Monitoring Support
• Work closely with the regulatory affairs team to ensure that all scientific aspects of regulatory submissions are thorough and accurate.
• Provide scientific expertise for the preparation and submission of all regulatory filings.
• Represent the company in interactions with regulatory bodies, addressing scientific questions and ensuring compliance with industry standards.
• Support quality assurance and product monitoring teams in safety assessment and MDR reportability determinations.
• Promotional Marketing and Competitive Intelligence
• Collaborate with the marketing team to translate scientific data into compelling marketing messages that resonate with healthcare professionals and patients.
• Support promotional strategies by ensuring that all marketing materials are scientifically accurate and compliant with regulations.
• Develop scientific content for promotional materials, including brochures, websites, and digital media, to effectively communicate the value proposition of the company’s products.
• Support marketing on the scientific analysis of competitive landscape, identifying trends, emerging technologies, and potential threats in the urinary stone market.
• Support updates to the executive team on competitive activities, product developments, and regulatory changes that may impact the company’s scientific and business strategy.
• Team Development and Leadership
• Build, manage, and mentor a high-performing research and scientific affairs team.
• Provide leadership in the recruitment, development, and retention of key scientific talent.
• Foster a culture of innovation, collaboration, and scientific excellence within the company.
• Other requirements
• Perform 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 Calyxo, Inc. complies.
• Assist with additional activities as assigned by supervisor
• Contribute to the company culture of being trustworthy, ethical, efficient, and fun! 

 Who You Will Report To: 

• VP, Medical and Clinical Affairs

Requirements: 

• Advanced degrees, such as a PhD or MD, in a relevant scientific discipline (e.g., Life Sciences, Pharmaceutical Sciences, Clinical Research, or similar fields).
• Minimum of 5-7 years of experience in scientific affairs, clinical research, or drug development within the pharmaceutical or biotech industry, preferably in urology, nephrology, or related fields.
• Proven track record of managing clinical pipelines, regulatory submissions, and R&D projects.
• Strong publication record and experience in scientific communications, including peer-reviewed publications, abstracts, and scientific presentations.
• Demonstrated ability to interact with regulatory bodies, industry professionals, and key stakeholders.
• Expertise in competitive intelligence and market analysis.
• Strong strategic thinking, leadership, 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.

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 a compensation plan as follows: 

• Competitive base salary range of $210,000 - $230,000
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid time off