Director, Device Clinical Affairs

Fibrogen

$178,000.00-$245,000.00 base; bonus/equity: cash b...
Not specified
Implantable medical devices
Clinical development strategies
Regulatory submissions
Fibrogen is seeking a Director of Device Clinical Affairs to lead the strategic and operational aspects of clinical programs for implantable medical devices. The role requires extensive experience in clinical trials and regulatory compliance, focusing on the successful execution of complex studies

Job Summary

  • Lead the execution of device clinical studies, ensuring compliance with applicable regulations and internal procedures.
  • Manage relationships with subject matter experts, key opinion leaders, and investigators to support high-quality clinical data and submissions.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

Match Score: 85

Fibrogen is seeking a Director of Device Clinical Affairs to lead the strategic and operational aspects of clinical programs for implantable medical devices. The role requires extensive experience in clinical trials and regulatory compliance, focusing on the successful execution of complex studies.

Salary

$178,000.00-$245,000.00 Base; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, Paid Maternity and Parental Leave, 401(k) with match, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • implantable medical devices
  • clinical development strategies
  • regulatory submissions
  • IDE and GCP requirements
  • CRO relationships

Nice-to-have

  • pioneering spirit
  • learning and growth opportunities
  • inclusion and belonging
  • collaboration and innovation

Key Requirements

  • Bachelor’s degree and 12 years’ experience
  • Minimum 6 years supervisory experience with ACRP/SOCRA certification
  • Experience with US FDA and European regulatory authorities
  • High level of organizational and project management skills
  • Ability to travel domestically and internationally

Work Rights

Not specified

Tailored Resume

Cover Letter