Vice President, Deputy General Counsel, Compliance

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Vice President, Deputy General Counsel, Compliance

AVROBIO, Inc. is seeking an exceptional, energetic, business-minded attorney with demonstrated experience advising biotechnology or pharmaceutical companies on healthcare compliance matters and the design, implementation, and oversight of effective compliance programs. Reporting to the Chief Legal Officer, this individual will be the third lawyer at an exciting, fast-growing and innovative clinical-stage gene therapy company.

Cambridge
Legal
Apr 1 2021
Key Responsibilities
  • Provide advice and counsel on a day-to-day basis to ensure the Company is in compliance with applicable FDA regulations, advertising and promotion, fraud and abuse, privacy, and anti-bribery laws and regulations, interactions with patients, healthcare professionals and other external parties, state law compliance and reporting requirements, and other aspects of federal and state laws and regulations governing pre-clinical research, clinical development, manufacturing and pre-commercialization of the Company’s gene therapies.
  • Design, implement, monitor and enforce a Company-wide compliance program and associated policies and procedures in order to promote and reinforce a culture of ethical business conduct, principles and practices, in conformity with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance) and industry best practices.
  • Develop and execute a comprehensive compliance training program for employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company’s compliance program.
  • Serve as the lead legal resource for the Company’s Medical, Clinical Development, Patient Advocacy and Engagement, Commercial and Regulatory teams.
  • Provide compliance guidance and oversight in the review of scientific, clinical, medical, corporate, educational, and training materials and programs to ensure compliance with applicable laws, rules and regulations, including advising on advisory boards, scientific and medical conference materials and publications, grants, sponsorships, donations, and other initiatives involving interactions with healthcare professionals, patients, and patient advocacy organizations.
  • Draft, review and negotiate contracts including clinical trial agreements, commercial contracts, third party vendor agreements, consulting and other agreements, informed consent forms and advising on fair market value (FMV) metrics.
  • Institute and maintain effective compliance communications within the Company by promoting awareness and retention of the Code of Business Conduct, the use of the Company’s compliance hotline, as well as other means for employees to report compliance-related concerns or engage with senior leadership.
  • Monitor and advise on new and proposed legal and regulatory developments, market trends and best practices in the areas of healthcare compliance, FDA, privacy, and emerging regulatory risk areas to ensure the Company’s continued compliance.
  • Identify potential areas of compliance vulnerability and enterprise risk and collaborate with functional leaders to strengthen the Company’s practices as appropriate to mitigate risk.
  • Regularly educate and inform employees on matters related to the Company’s compliance program, including providing periodic reports for members of senior management, the board and other stakeholders regarding the Company’s compliance efforts, risks and effectiveness.
  • Obtain and maintain a strong working knowledge of the Company’s business, scientific capabilities, and key strategic business objectives.
Minimum Requirements/ Qualifications
  • 5 to 10+ years as a practicing attorney in the field of healthcare compliance advising both clinical-stage and commercial biotechnology or pharmaceutical companies; prior in-house and law firm experience preferred.
  • Extensive expertise with compliance matters relating to the development, approval and commercialization of biotechnology or pharmaceutical products, privacy, and FDA issues, with an understanding of the OIG Guidance, applicable laws and regulations relating to the development, advertising, promotion, sales and marketing of pharmaceutical products and the current federal and state enforcement landscape.
  • Experience developing and implementing effective compliance policies and programs.
  • Comprehensive knowledge of U.S. healthcare fraud and abuse laws, FDA, OIG, FCPA, and CMS regulations, rules and guidances, pharmaceutical marketing, price reporting, privacy, federal and state disclosure requirements.
  • Experience in drafting and negotiating a range of agreements relating to research, clinical, and commercial activities relevant to a biotechnology or pharmaceutical company.
  • JD degree from an accredited law school.
  • Current member in good standing of a U.S. state bar (Massachusetts preferred).

Other Skills and Abilities

  • Strong written and oral communications skills required to work both internally and externally.
  • Ability to meet deadlines while managing a substantial workload in a fast-paced environment.
  • Ability to recognize risk and develop workable strategies to mitigate such risk.
  • Ability to engender confidence when advising clients at all levels.
  • Ability to work with little oversight.
  • Ability to work with the highest level of integrity is essential.
  • Excellent business judgment and strategic thinking.
  • Flexibility and willingness to work on a broad variety of legal matters.
  • Ability to travel (approximately 10%) as required.
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer