Principal Regulatory Solutions Architect

Company Description

DNAnexus is a leading provider of secure, scalable, and intuitive biomedical data analysis software and bioinformatics applications for the life sciences and healthcare communities. The company actively manages and supports more than 80 petabytes of complex genomic, multi-omic, and clinical datasets on behalf of a growing network of collaborations with large-scale biobanks, as well as leading pharmaceutical, clinical diagnostic, academic research, and government organizations. Over 40,000 scientists across 48 countries are now using the highly collaborative, cloud-based, end-to-end platform to gain data-driven insights that can advance scientific discovery, accelerate precision medicine, and improve patient care.

Business Unit Description

DNAnexus' Regulatory Solutions provides vision and execution for the FDA's flagship FedRAMP Authorized multi-omics and RWD collaborative analysis platform, precisionFDA.gov. At the confluence of biological science, cloud computing, and regulation of drugs and devices, DNAnexus enables new paradigms and efficiencies in cloud-based regulatory science and review for the ultimate benefit of patients. DNAnexus actively manages more than 80 petabytes of genomic, multi-omic, and clinical datasets for a growing network of large-scale biobanks, global pharmaceutical companies, diagnostic test providers, academic research, and government organizations.

Job Description

This is a unique opportunity to contribute to envisioning, creating, and delivering authorized cloud solutions built on the DNAnexus global platform and change the paradigm for interaction between global pharmaceutical companies, and international regulators and patient advocacy groups. You will work directly with the FDA and other international regulators, global pharmaceutical companies, large systems integrators, and patient advocacy groups to advance a wide range of regulatory science and review objectives, while directly contributing to growing Regulatory Solutions revenue and company value.

You will be an expert representative for precisionFDA, working with the DNAnexus Chief Cloud Officer and precisionFDA Program Director and Engineering Team to envision new and enhanced capabilities, and to drive the strategic scientific research and regulatory advancement projects that are rapidly extending DNAnexus' reach into the international regulatory space.

Your work will cover a wide range of disciplines and there will be many opportunities to learn. 

Your world in acronyms will encompass (but not be limited to) FISMA, FedRAMP, ISO-9001, GDPR, GxP, 21 CFR Part 11, QMS, HL7, CDISC, SDTM, OMOP, FHIR, BAM, FASTQ, VCF, DNA-seq, RNA-seq, scRNA-seq, HRD, TMB, I-O, TCR, BCR, FOCR, OCE, DIA, CBER, CDER, CDRH, ODAR, EMA, MHRA, ICMRA, ICH, DIA, AWS, MSFT....

Who We’re Looking For

The following leadership principles (https://www.amazon.jobs/content/en-gb/our-workplace/leadership-principles) are highly valued for this role, in priority order:

• Customer Obsession
• Bias for Action
• Learn and Be Curious
• Dive Deep
• Insist on the Highest Standards
• Deliver Results
• Are Right, A Lot

Demonstration of the above will support the other high valued principle for this role, Earn Trust.

You are fanatical about creating a delightful customer and partner User Experience (UX). UX quality is foundational to all the work that you do regardless of whether it is scientific, technical, or contractual. You leverage your coding and media production skills to enable users and developers to independently gain maximum value with minimal effort.

Security, privacy, and compliance are paramount in all your interactions, designs, and deliverables.

You are adept in creating new value from existing capabilities and developing profitable solutions by packaging up current products in a novel manner.

You can sell your ideas and solutions and create real business value from them. You have no problem getting hands-on and testing your ideas in the cloud. You are revenue, profit, and growth focused and understand how your work contributes to company objectives.

You are an outstanding problem solver and researcher and are able to independently resolve issues and blockers to successfully deliver on commitments.

Qualifications

The role requires:

• Delivery of concise, in-depth, and technically and scientifically accurate written and interpersonal communications.
• Excellent judgement and discretion in the sharing of information.
• Researching, learning, and delivering solutions across scientific, cloud, security and compliance, and regulatory domains.
• Earning trust and working as an independent contributor across customer, partner, and DNAnexus teams.
• Specification of solutions and working with external and internal stakeholders in an Agile manner to deliver them.
• Developing the technical, scientific, regulatory, and business components of proposals.
• Leading porting and development of bioinformatics, data analysis, and regulatory submission informatics applications and workstations to precisionFDA.
• Developing graphics, narration, video, and code for user and developer tutorials and conceptual presentations and delivering these materials to a wide range of audiences.
• Working with Linux shell scripting and PostgreSQL and MySQL databases to test platform capabilities and prototype solutions.
• Contributing to multiple high-visibility projects at the FDA and other international regulators to define the platform for global trusted regulatory spaces.
• 10 years’ experience in life sciences and a solid understanding of NGS, multi-omics and bioinformatics.
• A bachelor’s degree in computational biology, computer science, drug development, public health, or related field of study or 12 years of related work experience. 

Desired Qualifications

The role desires experience with:

• R, SAS, and Python
• Regulatory submission and information management applications software
• The CDER and CBER regulatory review process systems
• International regulatory review
• FDA guidance for use of informatics, genomics, AI, and RWE in regulatory submissions
• DevOps for SaaS or PaaS or at a cloud service provider
• Database servers, command line clients, and administration tools
• SQL and other languages for data wrangling and ETL
• Clinical data representation in FHIR and OMOP and data access tools
• Cloud and network architecture specification
• Docker
• PhD in computational biology, computer science, or related field of study

Salary and Other Compensation:
The total annual cash compensation for this position is between $125K and $160K with both a base salary and annual bonus component. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, flexible paid time off, 12 weeks of paid parental leave, and national holidays paid.

Additional Information

Headquartered in Mountain View, California, with over 220 team members across the United States and Europe, DNAnexus is experiencing rapid growth and market adoption. With the support of leading investors including Google Ventures and Blackstone, and trusted by hundreds of the world's biomedical leaders,  the company is at the innovative forefront with our precision health data cloud to drive scientific breakthroughs.   If you are interested in joining our team, please apply today!