Vice President, Bioinformatics

Location: Remote, Hybrid, or Onsite in Boulder, CO

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

The Vice President, Bioinformatics is a strategic a collaborative role overseeing bioinformatics and computational biology efforts supporting clinical validation studies and regulatory submissions, including FDA interactions. Reporting to the CEO/CSO, the VP, Bioinformatics will lead study design for both regulated and non-regulated programs, with a focus on clinical trials, custom panel development, and companion diagnostics. The ideal candidate brings proven experience in regulatory study design, data analysis, and direct FDA engagement, including presenting and defending analytical approaches. This is a player-coach role with responsibility for technical oversight and growing a cross-functional team, with team growth scaling to align with clinical trial activity. Success in this role will require strong collaboration across scientific, regulatory, and program management functions, particularly in support of FDA submissions.

What You Will Do

• 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.

• Ensure turnaround time and contractual obligations are consistently met.

• Oversee compliance with applicable regulatory and quality standards, including LDT, FDA medical device, IVDR, and other relevant regulations, ensuring proper compliance documentation and evidence.

• 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.

• Manage change control processes for production environments, ensuring smooth and compliant transitions.

• 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.

• Establish clear goals, expectations, and performance metrics supporting team accountability and excellence.

• Conduct regular performance evaluations to enforce team performance accountability, provide constructive feedback, implement professional development plans, and timely corrective actions when necessary.

• Manage bioinformatics talent acquisition, onboarding, and succession planning.

• 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

• PhD in Bioinformatics, Computational Biology, Computer Science, or a related field with 10+ years of relevant experience.

• 5+ years of leadership experience, with increasing responsibility managing teams, with experience managing remote teams highly preferred.

• 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.

• Ability to travel up to 10% as needed.

Desired Qualities

• 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

This role is hiring at an annual salary of $260,000 - $275,000 and is eligible for equity and bonus 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 June 15, 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.