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Full-Time

Compliance Manager

Posted on 6/28/2024

Adaptive Biotechnologies

Adaptive Biotechnologies

501-1,000 employees

Decodes immune cell receptors for diagnostics

Hardware
Biotechnology
Healthcare

Compensation Overview

$108.2k - $162.3kAnnually

+ Equity Grant + Bonus

Senior, Expert

Remote in USA

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Bachelor’s degree and 7+ years, or Masters and 5+ years of recent, relevant in-house experience or law firm experience in a pharmaceutical, biotechnology, or lab industry
  • Knowledge of and experience with US laws, regulations, and industry guidance that affect the pharmaceutical, biotechnology, or lab industry
Responsibilities
  • Manage, provide oversight, and compliance guidance related to engagements with healthcare professionals globally
  • Provide oversight and strategic direction related to sponsorships and grants requests
  • Provide assistance in preparing and validating the federal and state transparency reports, such as the US Sunshine Act
  • Provide strategic direction for the US Compliance function across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices
  • Partner with and advise business stakeholders to prepare an annual compliance work plan based upon a comprehensive, annual compliance risk assessment
  • Proactively plan for emerging trends in compliance, anticipate the impact on processes, and work with business stakeholders to determine how to address them using the most up to date information around emerging state and federal laws, U.S. government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
  • Advise and provide support to business functions to maintain an internal infrastructure that supports a culture of compliance and recognizes that compliance is a collective responsibility of all employees
  • Establish strong relationships with key internal stakeholders to understand current and future compliance needs
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including antikickback and fraud and abuse laws, transparency laws, OIG and DOJ guidelines, and industry standards, such as the AdvaMed and MedTech codes
  • Provide guidance to the business and integrate compliance controls into the scope of existing business practices where applicable
  • Partner with corporate compliance investigations regarding potential violations of compliance policies, laws or regulations and oversee corrective actions with business functions
  • Work with internal audit to develop annual audit plans for the business and work with the business to timely complete corrective action plans
Adaptive Biotechnologies

Adaptive Biotechnologies

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Adaptive Biotechnologies focuses on using the immune system to improve disease diagnosis and treatment. The company decodes genetic information from immune cell receptors, which are essential for the immune system's ability to identify and respond to diseases. One of their key projects is the ImmuneRACE study, which analyzes blood samples and swabs from participants to understand how the immune system reacts to COVID-19. This research aims to enhance diagnostics, treatments, and vaccines for the virus. Adaptive Biotechnologies generates revenue by partnering with pharmaceutical companies, licensing their technology, and offering diagnostic services. Their goal is to leverage immune system data to advance healthcare solutions for various diseases.

Company Stage

IPO

Total Funding

$575.5M

Headquarters

Seattle, Washington

Founded

2009

Growth & Insights
Headcount

6 month growth

-4%

1 year growth

-8%

2 year growth

-10%
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Simplify's Take

What believers are saying

  • Adaptive Biotechnologies' partnerships with pharmaceutical companies and healthcare providers offer significant growth opportunities and revenue streams.
  • Winning the Workplace of the Year Award highlights their strong company culture and employee satisfaction, making it an attractive place to work.
  • Their collaboration with BeiGene on minimal residual disease measurement could lead to groundbreaking advancements in cancer treatment.

What critics are saying

  • The departure of key board members like Kevin Conroy and Leslie Trigg could lead to strategic instability.
  • The highly competitive biotechnology sector requires continuous innovation to maintain market position.

What makes Adaptive Biotechnologies unique

  • Adaptive Biotechnologies leverages the genetic information of immune cell receptors to develop advanced diagnostic tools and treatments, setting it apart from traditional biotech firms.
  • Their ImmuneRACE study, focusing on COVID-19 immune response, showcases their commitment to addressing current global health challenges.
  • The integration of their clonoSEQ® assay with Epic systems enhances their diagnostic capabilities, providing a seamless experience for healthcare providers.
INACTIVE