Principle Scientist, Regulatory Bioinformatics

Location: Remote, Hybrid, or On-Site in Boulder, Colorado, United States

About our Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role

Foresight Diagnostics is seeking an accomplished Principal Scientist, Regulatory Bioinformatics to join our innovative team. This is a player-coach role that includes both senior individual contributions along with management responsibilities. You will drive cutting-edge bioinformatics solutions while leading, coaching, and mentoring a growing, remote team. The ideal candidate will have a proven ability to design and execute complex analyses, lead the development of algorithms and software utilized in medical device applications, and supporting the career and growth of other bioinformatic scientists and engineers. Experience working with the FDA or supporting regulatory submissions is highly preferred.

Remote candidates in the United States are encouraged to apply. Our team is remote, but candidates can work at our main office in Boulder, CO if they prefer.

What You Will Do

Individual Contributions

• 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.

Leadership

• 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.

What You Will Bring

• 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.

Desired Qualities

• 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.

Compensation & Benefits

This role is hiring at a salary between $185,000 - $235,000 and is eligible for bonus and equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

The application deadline for this position is July 30, 2025.

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.