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.
See more jobs at DNAnexus
Apply for this job
