Director - IVD/CDx Assay Development (ADX-211-19) at ArcherDX

| Greater Boulder Area
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Director - IVD/CDx Assay Development (ADX-211-19)
 
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 enhance 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. 
 
POSITION SUMMARY:
 
Residing in our Boulder, CO office, the Director- IVD/CDx Assay Development is key member of a rapidly growing IVD and Companion Diagnostics product development team in leading a group responsible for developing and optimizing one or more IVD assays using cutting-edge NGS technology. Will be responsible for developing, execution, and critical evaluation of experimental designs in support of clinically geared projects leading to the FDA submission. 
 
Will work closely with R&D, Quality, Regulatory, Clinical, and Production teams to translate laboratory processes from feasibility to validated assay. Additionally, they will work closely with the Marketing, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong leadership and multi-discipline skills from technical, to writing, to communication. 
 
RESPONSIBILITIES:
  • Coordinate and oversee the full implementation and execution of programs with external and internal collaborators within the accepted timelines, budgets and resources
  • Drive the overall product development planning and implementation strategy for Companion Diagnostics product(s)
  • Oversee verification and validation protocols and study execution under Design Control 
  • Oversee the study data analysis and study reports writing
  • Participate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory) 
  • Participate in the planning, writing and implementation of laboratory focused clinical trials and collaborative studies.
  • Serve as a liaison to Technical, Clinical Development & Operations for clinical biomarker validation activities
  • Draft technical regulatory documents for CDx applications for regulatory approval
  • Develop status reports for Executive Team and external collaborators
  • Publish scientific results 
 
Requirements:
  • MS/PhD in biology, molecular biology, biochemistry or related field
  • Minimum of 15 years' experience in the diagnostic or pharmaceutical industry
  • Strong experience with design control, verification and validation of FDA-regulated products
  • Proficiency in NGS, PCR, qPCR, and sample prep techniques 
  • Experience writing protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications
  • Knowledge of principles of quality control and quality assurance
  • Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management
  • Experience growing a team in meeting company growth objectives
  • Self-driven, starter who is comfortable in fast-paced environment 
  • Effective leadership and communication skills
  • Able to organize and prioritize diverse responsibilities to achieve company goals
  • Demonstrates strong leadership capabilities with the ability to lead multiple projects through a complex development program
  • Handles tight timelines and stress in a constructive manner
  • High attention to detail, with the ability to create clear and concise technical documentation
 
 
 
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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