Vice President, Compliance & Regulatory Counsel

Aveo Oncology • Boston, MA

4d • Onsite

About The Position

The Compliance & Regulatory Counsel is responsible for advising on a variety of healthcare-related legal, regulatory and compliance issues governing on-market and pipeline products, with a primary focus on the Anti-Kickback Statute, False Claims Act and advertising and promotional regulations. The Compliance & Regulatory Counsel will work closely with senior management, members of the legal department and other business departments, as needed. The Compliance & Regulatory Counsel will report directly to the General Counsel and serve as the Chief Compliance Officer. The Compliance & Regulatory Counsel will manage and support daily activities relating to pharmaceutical compliance. The Compliance & Regulatory Counsel will be involved in the oversight and management of AVEO's compliance and ethics program, ensuring that AVEO exercises due diligence and sound internal controls to operate with integrity and protect against legal risks.

Requirements

• Juris Doctor (J.D.) or equivalent from an accredited law school and admission in good standing to a state bar.
• Minimum of 10+ years of relevant experience (combination of compliance-related inhouse and/or law firm work experience).
• Experience in providing legal expertise/guidance to product development and strategy.
• Experience supporting a pharmaceutical commercialized brand required.
• Experience with leading educational sessions regarding compliance and branding for senior leadership, key stakeholders, the legal team and the company.
• Experience in providing an enterprise view in developing and delivering legal guidance to internal stakeholders.
• Possess significant expertise in all areas of U.S. laws and regulations including FDA, anti kickback, antitrust, privacy and product liability.
• Excellent client service and written/verbal communication skills required.
• High level of professionalism with strong judgment and commitment to ethical issues.
• Must be detail oriented with outstanding organizational skills and the proven ability to handle multiple responsibilities simultaneously while maintaining high quality and performance under pressure.
• Ability to work independently and with a diverse set of personalities in a team environment.
• Results-driven, has a strong sense of urgency and is able to drive results.
• Business-minded and comfortable in an entrepreneurial, fast-paced environment where demands and priorities change rapidly.
• Able to effectively interact with, influence and collaborate with other members of the organization.
• Proven track record of learning quickly, taking initiative, working proactively, being resourceful, and taking on additional responsibility.

Nice To Haves

• Experience with working with Market Access/Managed Health Care matters is desirable.
• 10+ years in the U.S. and International healthcare compliance experience.
• Experience with a senior compliance role in global cross-cultural and cross-functional teams, including implementation of global compliance programs.
• Project Management and System Implementation experience.
• High risk awareness and risk management skills.

Responsibilities

• Implement robust compliance policies and procedures to meet all regulatory standards and state and federal guidelines.
• Maintain, implement and manage all training on compliance-related subjects and processes.
• Monitor employee compliance with policies and procedures.
• Assist in investigations, as necessary.
• Maintain and manage transparency reporting under the Sunshine Act and relevant state laws.
• Keep abreast and monitor all state and federal regulations affecting the pharmaceutical industry and report upcoming changes in federal and/or state laws.
• Review and draft legal documents and advise employees on legal and regulatory issues related to vendors, projects, and sales and marketing.
• Provide clear and substantive advice to senior management and business clients (Commercial Sales Force, Marketing, Market Access, Medical Affairs and Regulatory Affairs departments) on a broad range of legal, regulatory and compliance issues focusing on areas of promotion, patient support, payor access, go-to-market strategies, and scientific exchange. These include FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act and competition law in connection with product labeling, promotional and non promotional activities.
• Advise cross-functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use.
• Provide counsel on appropriate relationships with a variety of external parties including healthcare professionals, patients, academic institutions, and payors.
• Review business materials (including brand plans, promotions, medical plans and training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics.
• Provide legal advice and assistance for the development of policies and training, and conducts training.
• Collaborate with R&D and IP colleagues involved with late-stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products.
• Advise the General Counsel of project developments in a timely manner.
• Provide subject matter expertise on a variety of agreements including complex commercial agreements, third party vendor agreements, service agreements, pharmacy agreements, consulting agreements and other corporate agreements.
• Keep abreast of regulatory developments to identify the potential impact to AVEO’s business.
• Identify potential areas of compliance risk and vulnerability and help develop additional policies and procedures to help minimize that risk.
• Manage vendors and other third-party screenings to identify and mitigate potential corruption and other risks to the company.
• Assist with the development and delivery of compliance training programs.
• Compile and analyze information from such legal reviews to propose revisions to compliance policies and procedures as needed.
• Help select and direct the work of outside counsel, define project objectives, manage project and budget, as needed.
• Partner with Commercial, Medical Affairs, Market Access, Regulatory Affairs, and Clinical Development to provide practical legal and compliance guidance.
• Support compliance risk assessments and recommend solutions to mitigate identified risks.
• Support compliance monitoring, auditing, and corrective action initiatives to strengthen the compliance program.
• Provide legal and compliance guidance regarding healthcare professional (HCP) engagements, including advisory boards, consulting arrangements, and speaker programs.
• Serve as the Legal representative on the Material Review Committee (MRC), providing legal and regulatory guidance for promotional and medical review activities.
• Support compliance initiatives, regulatory inquiries, audits, and other cross-functional projects, as needed.
• Contribute to the development of AVEO’s compliance focused culture.

Benefits

• AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree