Head of Compliance

Location
Hayward, CA, United States
Posted
Jan 08, 2021
Ref
161
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
We're currently seeking an individual who thrives in a fast-paced and high-performing environment to join our company as Head of Compliance. Reporting to the General Counsel, the Head of Compliance will lead the design and implementation of a comprehensive compliance program that will foster a culture of compliance as the company pursues its mission to develop innovative cancer immunotherapies.

Essential Duties and Responsibilities:
  • Develop company-wide compliance policies and procedures that integrate appropriate healthcare, corporate, privacy and other compliance controls to guide the company's operations
  • Develop and monitor the execution of a training program for new and existing employees to ensure a thorough understanding and appreciation of the laws that impact the company's operations and how to conduct business practices appropriately
  • Provides legal support for the company's expanding international operations, proactively identify legal and regulatory issues, and collaborate cross-functionally to offer creative solutions to mitigate risks
  • Provide timely guidance and compliance oversight on company initiatives, such as HCP consulting agreements, advisory boards, speaker programs, sponsorships, grants and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups
  • Identifies emerging industry and company trends to mitigate compliance risks through preparation and preemptive education
  • Conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the company identifies potential compliance risks and remediates where necessary
  • Partner with internal (e.g., Legal and Human Resources) and external (e.g., outside counsel or investigators) stakeholders for the conduct and resolution of potential compliance investigations, including the management of any resulting corrective actions plans
  • Create and maintain dashboards or other reporting tools to track and assess compliance risks; p repare updates, presentations, and compliance reports for executive management, as necessary.
  • May provide support on other policy and procedure implementation governing business operations


Qualifications:
  • 4+ years of experience in the biopharmaceutical industry and/or nationally recognized law firm or consulting practice
  • Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations
  • Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations
  • Knowledge of U.S. and foreign compliance and regulatory matters, including S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), Foreign Corrupt Practices Act, privacy laws (e.g., GDPR and CCPA), and Sunshine and transparency laws
  • Ability to work independently, while meeting aggressive deadlines and juggling complex matters
  • Enthusiastic and resourceful
  • Process oriented with attention to detail and strong analytical thinking and data analysis skills
  • Excellent communication skills, both verbal and written