Bioinformatics Group Lead

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as their accomplished Bioinformatics Group Lead. This player-coach role blends individual contributions with management responsibilities, requiring you to lead a growing remote team while driving cutting-edge bioinformatics solutions. You will design and execute complex analyses, develop algorithms and software for medical devices, and collaborate with various teams. Experience with the FDA and regulatory submissions is highly preferred. Remote work is available, with the option to work in Boulder, CO. The role offers a competitive salary, equity, and comprehensive benefits.

Requirements

• BS, 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
• 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

• Experience working in a regulated domain
• 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

• Salary between $170,000 - $205,000
• Equity offerings
• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical, dental, vision, life, disability coverage
• Flexible spending accounts
• 401k with company match
• Professional development opportunities