Chief Compliance Officer

We are searching for a Chief Compliance Officer (a Vice President level position) to join our company as we transition to commercial operations. We are looking for a candidate who is proactive, well-organized, and will be able to work collaboratively with a strong attention to detail. 
This is a hybrid role - our work from home days are Monday and Friday and our in-office days are Tuesday, Wednesday and Thursday.
Summary:
The Chief Compliance Officer will help to develop, implement, and maintain an effective compliance program, serving as the primary individual responsible for inspiring a strong compliance culture at the company, assuring employee understanding of their responsibilities and adherence to the company's Code of Conduct and compliance policies and guidelines by means of effective communication, training, monitoring, auditing, and investigation activities. The Chief Compliance Officer will report to the company's General Counsel. The Chief Compliance Officer will chair the company’s Compliance Committee and regularly meet with the CEO and other members of the senior management team on the effectiveness of the company's ethics and compliance programs and specific compliance matters. 
Essential Functions and Job Responsibilities:
Develop, implement, and maintain an effective and integrated compliance program to help prevent illegal, unethical, or improper conduct; in particular, as Chief Compliance Officer you will:

• Develop,  implement, and maintain policies and guidelines to help ensure adherence to applicable laws, rules, regulations, and industry standards such as the Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, the False Claims Act, the Department of Health and Human Services Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals,  Health Insurance Portability and Accountability Act (HIPAA), transparency reporting, anti-corruption/anti-bribery, and antitrust/competition.   
• Collaborate with various company leaders, particularly with commercial and medical affairs teams and other stakeholders to develop, implement, and maintain the key elements of the company’s compliance program.
• Interact with the company Board and the Committees of the Board as well as the senior management team to ensure that all are adequately informed on the company’s compliance matters.
• Conduct annual enterprise-wide risk assessments that assess external and internal risk factors in order to develop and implement a “Work Plan” for conducting annual compliance program initiatives. 
• Develop and implement annual reviews of and updates to the company compliance program.
• Create and implement a company-wide compliance training program that adequately and effectively trains employees on the key elements of the company’s compliance program.
• Investigate allegations of violations of the company’s Code of Conduct and compliance policies and guidelines; conduct/coordinate investigations; communicate findings to the appropriate senior leadership and/or Board Committee, as necessary.  Assist in managing potential litigation and investigations related to the company’s compliance program.
• Monitor state, federal and international legislative landscapes to stay informed on applicable proposed laws, rules, regulations and industry standards that the company must follow in regard to its interactions with the healthcare community. Review the proposed or new laws, rules, regulations, and industry standards and provide frequent updates and summaries to executive management and the Board on proposed or new requirements as they relate to the company’s interactions with the healthcare community.
• Oversee follow-up on matters reported through the company's global helpline and oversee an effective program for routine monitoring and auditing of adherence to corporate compliance policies and guidelines; identify potential areas of compliance vulnerability and risk, and opportunities for enhanced training, and develop and implement corrective action plans as necessary.
• Establish and chair a compliance committee to provide governance and evaluation of the company’s compliance program and any alleged violations of such program.
• Ensure proper reporting of violations to duly authorized enforcement agencies as appropriate or required.
• Oversee and ensure annual federal, state, and local compliance transparency reporting submissions and declarations are conducted as required.

Education, Requirements and Experience:

•  Bachelor’s Degree is required. A graduate degree (e.g., MBA, JD, etc.) is preferred.
• Minimum of 15 years of ethics, compliance, or legal experience in an organization subject to U.S. biopharmaceutical regulations, with at least 5 years as an ethics and compliance leader in a biopharmaceutical therapeutics company, with expert knowledge of healthcare and anti-corruption laws.
• Significant executive level biopharmaceutical compliance experience, with demonstrable exposure to building and operating compliance programs.
• Must be able to work cooperatively and influence effectively in a team environment with a wide variety of company employees and leaders on a broad range of matters, including physicians, scientists, and senior leaders of different disciplines.
• Ability to manage multiple tasks simultaneously and to flourish in a fast-paced, high-growth and high stress environment.
• A successful track record implementing/creating a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company’s business planning, operations, and culture.
• Excellent organization, communication (verbal and written – fluency in English required) and prioritization skills, including the ability to communicate concisely, to integrate legal, risk and business considerations, and to provide balanced advice regarding incremental and overall risks.
• Strong track record of developing, implementing, and maintaining effective, practical compliance systems and processes (e.g., transparency reporting and grant approval systems, HCP consultant fair market value review and approval process) and partnering with colleagues to ensure appropriate internal controls and monitoring are in place.
• Position requires national travel.

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