Vice President, Corporate Compliance

Summary The Vice President, Corporate Compliance is a key member of Aimmune's leadership team and will lead all aspects of the Company's Global Corporate Compliance function.  This position is based in Brisbane, California and local candidates are strongly preferred.  As Aimmune prepares for our first commercial launch the Vice President, Corporate Compliance will ensure that the company is compliant in all areas.  To ensure this, the Vice President, Corporate Compliance will be responsible for designing, implementing and maintaining a robust healthcare compliance program on a global level. In addition, the Vice President, Corporate Compliance reviews and evaluates compliance issues/concerns; monitors and reports on healthcare compliance/ethics efforts; and is responsible for building and leading multi-disciplinary efforts within the Company related to healthcare compliance. The Vice President, Corporate Compliance must exhibit the highest level of integrity and ethics. Responsibilities include investigations, the implementation of global compliance programs, risk assessments, internal control procedures, and the comprehensive analysis of exposure issues related to internal and government audits and investigations. Support the development, implementation, and maintenance of Global Compliance activities relating to the Anti-Bribery, Anti-Corruption Program ("ABAC"), including counseling and training on compliance policies, development of ABAC procedures, management of investigations, and support of partners to ensure business activities comport with global healthcare compliance regulations. Specific Responsibilities: Develop and execute on global ABAC program development, including: Support workable, business-oriented solutions for achieving fair market value in payments to HCPs and patient stakeholders worldwide Due Diligence: Refine process for vetting partners and consultants, leveraging external background check resources as well as internal systems, and ensure systematic escalation and vetting of "red flags" Monitoring andHealthcareAudits: Ensure that appropriate ABAC data monitoring, healthcare audits and assessments, and response protocols are in place to respond to developing risks Training: Partner with training program owners to ensure global and regionally tailored training is implemented, recorded, and updated as necessary Enforcement: Ensure appropriate discipline and consequences for ABAC policy violations based on "Global Progressive Discipline" policy. Create corrective action plans to ensure that business units implicated prevent future non-compliance Messaging: Ensure deterrence through company-wide messaging and information regarding ABAC risks and consequences for violative conduct (e.g., use regional communications or other training opportunities to discuss GCE's risk mitigation efforts) Dawn Raid Policy/Process and Training: Partner with training program owner to ensure regional GCE and business personnel are briefed, trained, and prepared for dawn raid scenarios Manage the Global Monitoring Program: Develop North America's regional heat map and monitoring plan, and establish uniform approach to global development of risk assessments and monitoring plans Support regional GCE personnel in establishing regional monitoring/audit plans Manage cross-regional coordination and communication: Provide centralized GCE support to business stakeholders undertaking global (cross-regional) activities, and support analysis of regional GCE activities and controls to ensure GCE takes a consistent global approach to compliance controls where workable, and that any regional inconsistencies are considered and appropriate Investigations Management: Manage investigations of alleged violations of compliance policies, laws, regulations, or procedures as needed on a global basis Develop and implement corrective action plans where compliance violations have been established General Global Compliance and Ethics Support: Assist with creation of a global training plan and training modules in connection with the ABAC Program. Present trainings to global business units and partners as needed Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes. Coordinate project management of various GCEP related activities and requirements, including management and coordination of outside consultants Preferred Experience, Special Skills, Knowledge: A Bachelor's degree and JD are required 10-15+ years in-house experience practicing law handling FCPA and/or ABAC matters or programs, including management of investigations. In-house experience in a biotechnology or pharmaceutical organization Broad experience with US healthcare compliance; experience with global compliance preferred Experience with privacy compliance preferred Demonstrated experience launching new compliance programs, from inception to implementation and beyond Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, and in particular issues arising under the FCPA, Anti-Kickback Statute, or other ABAC laws Demonstrated effectiveness operating in complex organizational and regulatory environments Excellent written, oral, and presentation skills Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients Strong problem solving, risk analysis, and project management skills Demonstrated ability to partner effectively with others in addressing complex issues Strong persuasive skills and sound business judgment Motivated, self-starter with ability to appropriately prioritize issues and allocate resources
Salary Range: NA
Minimum Qualification
11 - 15 years

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