Associate 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.

Job Summary

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 gene therapy company.

Cambridge
Legal
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, anti-kickback, 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 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 Clinical, Medical, Patient Advocacy and Engagement and Regulatory teams.
  • Provide compliance guidance and oversight in the review of scientific, clinical, medical, corporate, educational, marketing, promotional, advertising 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 agreements, informed consents and other agreements, including 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 risk for the Company and collaborate with functional leaders to strengthen the Company's practices as appropriate to mitigate risk.
  • Regularly educate and inform the Company’s senior management 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.
  • Ensure that the audit committee is immediately notified of concerns or reports of compliance violations.
  • 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; 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 understand 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.

 

LEADERSHIP SKILLS and CHARACTERISTICS THAT SPEAK TO WHAT WE VALUE

Pioneering

·        Understands that gene therapy is transformational and paradigm-breaking, and remains comfortable when facing uncertainty and new terrain. Possesses the ability to pivot readily and reshape to evolving business needs while remaining focused on doing the right thing, modeling ethical behavior. Possesses sound business judgment and strategic thinking, with the ability to influence others without serving as the authoritative figure. 

Problem Solver

·        Can solve even the toughest and most complex of problems. Great at recognizing risk and developing workable strategies to mitigate such riskFlexible and willing to work on a broad variety of legal and compliance matters.  Respectful and comfortable working through conflict; knows that crises happen, deals promptly and fairly through critical points.

Driven

·        Attacks everything with drive and energy, meeting deadlines while managing a substantial workload in a fast-paced environment; drives to finish everything he/she starts. Maneuvers well to get things done; politically aware and agile; knows what the right thing to do is. Works easily with little oversight. Works with the highest level of integrity.

Passionate

·        Is skilled at getting individuals, teams, and an entire organization to perform at a higher level of compliance. Communicates clearly in writing and orally developing a compelling vision of what excellence looks like and is committed to what needs to be done; inspires others.

Collaborative

·        Is open and receptive to working in teams at all levels within the organization. At ease and relaxed; easy to talk to and get to know; listens attentively; engenders confidence when advising clients at all levels and deals calmly with stress.

About AVROBIO

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer