Principle Scientist, Regulatory Bioinformatics

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as a Principal Scientist, Regulatory Bioinformatics. This player-coach role involves both individual contributions and team leadership. You will lead the design and execution of complex bioinformatics analyses, develop algorithms and software for medical device applications, and mentor a growing team. Experience with the FDA and regulatory submissions is highly preferred. Remote work is available, with the option to work on-site in Boulder, CO. The position offers a competitive salary, bonus, equity, and comprehensive benefits.

Requirements

• MS or PhD in Bioinformatics, Computational Biology, Computer Science, or a related field with at least 7 years of relevant experience
• Demonstrated expertise in the development of algorithms and software for medical devices, with an emphasis on diagnostic applications
• Proficiency in statistical modeling and analytical validation for FDA regulated medical devices
• Experience designing and analyzing complex studies, including clinical or genomic datasets
• Proven track record of working with regulatory bodies such as the FDA (e.g., 510(k), PMA, or Breakthrough Device Designation)
• Proficiency in Python (or similar languages), bioinformatics tools (SAMtools, GATK, Picard), and scripting tools (Bash) used for genomic analysis
• Experience with cloud computing environments, workflow management tools (e.g., Nextflow), and container technologies (e.g. Docker)
• Strong interpersonal and communication skills, with the ability to work effectively in a cross-functional team environment
• Successful history of coaching, mentoring, and providing feedback to support team members in their career growth

Responsibilities

• Lead the design and execution of complex studies and analyses, including statistical modeling, computational pipeline development, and genomic data interpretation
• Develop and validate algorithms and software solutions for medical device applications, ensuring compliance with regulatory and quality standards
• Collaborate with clinical, regulatory, and product development teams to integrate bioinformatics innovations into diagnostic tools and workflows
• Optimize and scale bioinformatics pipelines for processing high-throughput sequencing data in cloud-based environments
• Stay at the forefront of advancements in computational biology, bioinformatics, and medical device development to drive innovation
• Provide technical, strategic, and career guidance to the bioinformatics team, fostering a culture of excellence and continuous learning
• Oversee and contribute to the preparation of technical documentation, reports, and regulatory submissions
• Act as a bioinformatics subject-matter expert, representing the function in internal strategy discussions and external collaborations
• Drive cross-functional initiatives, ensuring alignment with organizational goals, timelines, and regulatory requirements

Preferred Qualifications

• Ability to understand and communicate needs and requirements for cloud-based execution and storage infrastructure
• Familiarity with software validation practices, quality systems, and compliance requirements (e.g., ISO 13485, IEC 62304)
• Adaptable to fast-paced, dynamic work environments and shifting demands
• Highly collaborative, team-oriented, and an effective communicator
• Passion for making a difference in the world

Benefits

• Paid vacation
• Sick time
• Parental leave
• Medical
• Dental
• Vision
• Life
• Disability coverage
• Flexible spending accounts
• 401k with company match
• Bonus
• Equity offerings