Reporting directly to the Chief Compliance Officer, Oncology, the Head of US Compliance and Deputy CCO leads US Compliance program and serves as the primary strategic partner to US business. This senior leadership role is responsible for navigating the compliance needs of a high-growth, diverse business landscape. The role provides a unique opportunity to support the US business while acting as a leader within Global Compliance organization. The successful candidate will blend deep technical expertise with sound judgment to scale compliance program.
Responsibilities
- Leverage knowledge of industry guidance, laws, codes and best practices to direct the design, implementation, and evolution of a comprehensive US Compliance Program, ensuring alignment with the OIG and DOJ guidelines
- Proactively plan for emerging trends in compliance, anticipating the impact of these trends on Company processes and controls
- Serve as a strategic advisor to Commercial, Medical Affairs, Patient Advocacy, R&D and other teams to enable innovation while proactively addressing compliance risks
- Partner with cross functional stakeholders to understand changing business practices, identify risks and adapt Compliance program elements to address emerging risks
- Chair the US Compliance Committee and provide regular updates to the Chief Compliance Officer, Oncology on program effectiveness, risk profiles, and mitigation strategies
- Lead the strategic development and implementation of a practical and business-oriented compliance training and communication program to empower Company personnel to manage risk with clarity, integrity and sound judgement
- Lead the development and maintenance of a US policy framework designed to establish clear, comprehensive and effective policies and procedures to aid the business in efficient decision making. Oversee initiatives to enhance policy accessibility
- Establish effective business processes and controls to ensure the Company is complying with its legal and regulatory obligations and undertake a continuous improvement process to timely identify and remediate any program gaps
- Set an appropriate tone of integrity and raise awareness of compliance as a collective responsibility of all Company personnel through effective engagement, training, auditing, and monitoring
- Partner with Head of Compliance Risk and Assurance to (i) identify monitoring needs, provide support for live monitoring and pull through monitoring results/analytics to business stakeholders; (ii) conduct planning and inputs for risk assessments; (iii) support annual transparency reporting; and (iv) support internal investigations
- Partner with business stakeholders in connection with the preparation of an annual compliance work plan
- Support various enterprise-wide initiatives led by Global Compliance function
- Manage, coach and develop assigned staff and third party resources
Qualifications
- Bachelor degree is required (a JD or other advanced degree or course of study strongly preferred)
- Minimum of 12 years of broad compliance experience in the pharmaceutical or biotechnology industry with at least 5 years in a senior leadership position.
- Exceptional working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry
- Ability to mentor and retain a high-performing team of compliance professionals, fostering a culture of continuous learning and professional accountability.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
