Vice President, Bioinformatics

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as their Vice President, Bioinformatics. This strategic role oversees bioinformatics and computational biology efforts supporting clinical validation studies and regulatory submissions, including FDA interactions. You will lead study design for regulated and non-regulated programs, focusing on clinical trials, custom panel development, and companion diagnostics. The position requires proven experience in regulatory study design, data analysis, and direct FDA engagement. It's a player-coach role involving technical oversight and team growth. Success demands strong collaboration across scientific, regulatory, and program management functions, especially for FDA submissions.

Requirements

• 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

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
• 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

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

Benefits

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