• Senior Director, Compliance

    Job Locations US-NJ-Princeton
    Category
    Legal
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.  

    The Compliance Officer (“CO”) is a member of the senior staff, reporting to the Vice President and General Counsel with additional oversight by the CEO.  The CO is responsible for managing an effective and credible compliance program that is consistent with current industry best practices and government guidance, e.g., the U.S. Sentencing Guidelines and HHS OIG Compliance Guidance for Pharmaceutical Manufacturers, i.e., “The Seven Elements”.  The CO will develop and execute annual compliance programs, monitoring and reporting results of the compliance/ethics efforts of the company and provide guidance and recommendations to senior management on matters relating to compliance, with a focus and priority on commercial compliance considerations.  Seeks opportunities and improve corporate compliance, including establishing strong working relationships by partnering with department/functional leaders so as to have a positive and productive relationship with compliance.  Periodic presentations to the company’s Board of Directors will also be required.  The CO is authorized to implement all necessary actions to ensure achievement of the objectives of an effective compliance program and to build and maintain a culture of compliance that enables the business to operate effectively while meeting government compliance standards for effectiveness.

    Responsibilities

    • Develops initiates, maintains, and revises policies and procedures for the general operation of the Compliance Program (the “Program”) and its related activities to prevent, detect, correct and report any illegal, unethical, or improper conduct as well as adherence to pharmaceutical regulations. Manages the day-to-day operation of the Program.
    • Establishes and chairs the Company’s Compliance Committee, holding regular and periodic meetings to coordinate the Program’s effective implementation and operation.
    • Develops and periodically reviews and updates the Company’s Code of Conduct to ensure continued currency and relevance in providing guidance to management and employees.
    • Collaborates and partners with other departments, e.g., Sales and Marketing, HR, Finance, Medical Affairs, etc., to coordinate compliance activities to identify and address their specific compliance needs, interests and requirements.
    • Collaborates with other departments to direct compliance issues to appropriate channels for investigation and resolution. Consults with corporate counsel as appropriate and necessary to address and resolve legal compliance issues, understanding the importance of maintaining attorney-client privilege when relevant and appropriate
    • Has expertise with pharmaceutical regulatory and compliance issues, including but not limited to relevant FDA regulations, Global Anti-Kickback Statutes, PDMA, HHS OIG Guidance, the PhRMA Code, the Sunshine Act, with a focus on product labeling, commercial and promotional activities, marketing strategies, sales compensation, and government reimbursement
    • Responds to alleged violations of rules, regulations, policies, procedures, and Code of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
    • Monitors, and as necessary, coordinates compliance activities of the company and informs necessary business partners of any changes in state or federal laws or regulations.
    • Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
    • Provides regular and periodic reports and/or dashboards, as directed or requested, to keep the Board and senior management informed of the operation, progress and effectiveness of compliance efforts.
    • Institutes and maintains an effective compliance communication program for the organization, including promoting (a) use of the Compliance Hotline; (b) heightened awareness of the Company’s Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.
    • Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees, ongoing training for all employees and managers and targeted training for specific areas of risk
    • Monitors the performance of the Program and relates activities on a continuing basis, taking appropriate steps to improve its effectiveness.

    Qualifications

    • Bachelor’s Degree required
    • A minimum of 7 years’ experience in a pharmaceutical of life sciences organization, to include demonstrated leadership. Familiarity with commercial, operational, financial, quality assurance, human resource procedures and pharmaceutical regulations is a must.
    • Strong working knowledge of the drug development process and commercial regulations in the USA is required. EU oncology clinical development experience is preferred.
    • Direct work experience with US and/or EU Regulatory authorities is highly preferred.
    • Highly detail and quality oriented.
    • Excellent presentation skills.
    • A positive attitude, flexibility and a proactive thought process.

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