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DNAnexus


DNAnexus® has built the world’s most secure cloud platform and global network for scientific collaboration and accelerated discovery. We embrace challenges and partnership to tackle the world’s most exciting opportunities in human health.

12d

Principal Regulatory Solutions Architect

DNAnexusMountain View, CA, Remote
agilesqlUXdockerpostgresqlmysqllinuxpythonAWS

DNAnexus is hiring a Remote Principal Regulatory Solutions Architect

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.

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DNAnexus is hiring a Remote National Account Director (Pharma)

Job Description

The National Account Director - Pharma (a field-based, individual contributor role) will be responsible for sales activity related to the successful outreach, development, and closure of DNAnexus business focused on accelerating translational research involving genomic and phenotypic/clinical data within the assigned geographic territory and named accounts. Focus will be placed on generating new business while growing and maintaining existing customer accounts. Current research and development, or clinical trial knowledge and expertise are preferred.  

Role Responsibilities

  • Work collaboratively with science, channels, and marketing to build, and execute, a successful business plan for your assigned territory
  • Maintain and grow the forecast projections for existing business
  • Identify and close new business opportunities in a timely manner
  • As the National Account Director, you will ensure that all of DNAnexus’ touch points and activities associated with a specific account are meeting customer expectations
  • Closely manage software trials and pilots through the establishment of mutually agreed upon success criteria that will result in a contract when successful
  • Contact via web-conference, telephone, email and in-person (*once safe/when required) current and prospective customers on a consistent and systematic basis to develop and bring to closure software license orders (net new and renewal business)
  • Engage and support channel partners at the field level
  • Coordinate attendance of current and prospective customers to web-based events and trade shows to drive knowledge, adoption and usage of the platform
  • Develop and maintain a 4x pipeline to quota of well qualified opportunities to meet and exceed all assigned business objectives and performance requirements on a quarterly and annual basis
  • Travel when necessary to develop and bring to closure business with new and existing customers
  • Demonstrate command of the DNAnexus product portfolio in-person, phone, or via web-conference

Qualifications

Preferred Requirements

  • Demonstrated sales and performance over achievement
  • Relevant precision medicine and/or informatics sales experience in the life sciences industry
  • Working knowledge of genomics, pharmaceutical research in general, and the analysis of sequencing data
  • Understanding of the clinical trial process along with current contacts a strong bonus
  • Sales experience and proven ability to negotiate contract terms
  • Aptitude for understanding and communicating scientific concepts, applications and methods.
  • Self-starter with a sense of urgency with regard to the handling and management of multiple sales tasks in a results oriented, technical selling environment
  • Meet and exceed assigned sales objectives & goals related to activity and opportunity development
  • Self-motivated with the ability to work independently while under guidance from manager
  • Excellent listening, written, and oral communication skills for all business levels
  • Accurate, timely, and complete data collection, entry and reporting skills
  • Working knowledge and use of Salesforce.com or related CRM, Google Workspace or Microsoft Office software suite
  • Ability to work in teams and be a team player that is driven by individual performance and contribution
  • Ability to travel up to 50% at times or as the job requires

Preferred Experience and Education

  • 5+ years direct selling experience of selling solutions into the research and discovery, and informatics domains within Life Sciences and/or Clinical Research.  
  • Knowledge of the clinical trial marketplace would be beneficial
  • BA/BS in business or related degree area with experience in genetics/genomics. It would be a plus if the candidate has an advanced degree in genetics, molecular biology, or similar area of study with lab experience in genetics or equivalent experience.

Salary and Other Compensation:

The annual starting OTE is between $200,000- 300,000.  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.

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