Director of Compliance

Austin, Texas, United States Full-time

About SubjectWell

SubjectWell is a venture-backed startup on an unstoppable mission to disrupt the antiquated $100 billion dollar clinical trial patient recruitment sector. Almost all clinical trials fall behind schedule, leaving patients unable to access the most promising treatments and pharmaceutical and biotech companies unable to quickly carry their innovations to market. SubjectWell was founded by two entrepreneurs on their third successful startup, to unlock the potential of a true marketplace for clinical trials. We leverage proven data science and performance marketing techniques to hit a hard reset to the massive patient recruitment challenge that sits at the critical nexus of speeding delivery of the best therapeutics to the world.

Here's your chance to really make a difference, both in your career and in the lives of millions.

 

About the Position

Ethical and legal stewardship of patient data is core to the success of SubjectWell.  The Director of Compliance will work with all aspects of the organization to develop, implement, and monitor tools and processes that ensure that we meet our responsibilities while going through a period of rapid growth and international expansion. This position has responsibility for the global compliance and regulatory affairs impacting the company.

Responsibilities and Duties

  • Create, foster and oversee the company’s culture of compliance.
  • Have primary oversight and responsibility regarding the firm’s SOPs and compliance with applicable laws.
  • Monitor applicable rules and regulations and update policies and procedures to maintain compliance.
  • Design compliance regimes to allow expansion into Europe, South America and Asia.
  • Collaborate with senior leadership on critical and complex aspects of Compliance findings and make operational recommendations.


Qualifications and Skills

  • Deep knowledge of US & European data privacy laws including HIPPA and GDPR
  • Knowledge of clinical trials standard and regulations, particularly around patient recruitment, including GCP, 21 CFR Part 50, and 21 CFR Part 56
  • Prior experience developing, training and monitoring SOPs
  • The ability to build tools and process that can mature with the organization

 

Education

  • Bachelor's degree

 

Benefits

  • Full Medical, Dental, and Vision Benefits
  • 401(k)
  • Company stock options
  • Paid time off
  • Paid holidays
  • Casual office
  • Flexible vacation