Director of Clinical Software Engineering (ADX-158-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
As the Director of Clinical Software Engineering, you will lead the development of our clinical products that are will be approved by regulatory authorities and used to diagnosis and provide treatment paths for patients around the world.
What this role will involve:
Leading the cross functional development of the clinical software offerings. The focus is on the development of the software system as a whole from the sequencer to the final result including the bioinformatics pipeline, web application, cloud infrastructure and security.
What you should know about us:
- The challenges and rewards of working in cancer genomics ensure that we are never bored.
- We have high standards. In our domain, details really matter.
- We take joy in teamwork and collaboration.
- Our tech stack includes Django, Postgres, AWS, VMWare, Docker, Jenkins, Terraform, git, Python, C++ and a ton of Bioinformatics tools.
- The software team is a multifunction group with technical leadership and includes specialists in bioinformatics, algorithm development, web development, UX design, DevOps, and software verification.
What we’re looking for:
- Extensive experience leading and coordinating a multidisciplinary team but both direct and matrixed reports
- Strong familiarity with AWS
- Familiarity with bioinformatics analysis
- Familiarity with cybersecurity
- A genuine appreciation for how wonderful automated testing and documentation is
- An appetite for continuous improvement
- An ability to communicate complex issues with clarity, respect, and tact
- A desire to be part of a tight-knit team of smart, passionate engineers and scientists
Bonus points for experience with and/or enthusiasm for:
- Working under a controlled software development life cycle
- Love of automated testing
- Good documentation
- Molecular biology / genomics
- Job performance will involve a variety of activities including:
- Provide strategic analytical leadership throughout the product development process
- Participate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory)
- Develop road maps for software development and operations based on cross functional need and timelines.
- Reviewing, understanding, and complying with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- 10+ professional experience in IT or software engineering
- 5+ years in software engineering experience
- 5+ years in management experience
- 3+ years in medical devices or other regulated
- Broad knowledge and experience across software lifecycles
- Experience with NGS is a plus
- Knowledge of genetics, familiarity with genomic data, NGS strongly preferred
- Working knowledge of cGMP/CFR/FDA regulations
- Experience with applicable FDA regulations and ISO standards, working knowledge of international regulations strongly preferred
- Drive and Determination
- Proven managerial skills to bring teams together to achieve common goals
- Demonstrated scientific "problem solving" skills
- Problem solver comfortable operating in the grey-space and driving forward with risk balanced decision making
- Strong communication and presentation skills
- Proven Ability to thrive in a start-up/change oriented environment
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