Chief Healthcare Compliance Officer, Genentech

Key Responsibilities

• Design, represent and implement enterprise-wide compliance strategy, objectives and initiatives at Genentech, based on the organization’s priorities, in close cooperation with company leadership at Genentech and Roche.
• Refined, monitor, and ensure implementation of Genentech’s Compliance Program in response to changes in the law, consult with department/program representatives to ensure programs effectiveness and support such efforts.
• Drive a culture of compliance with appropriate tone from the top by senior company leaders.
• Accountable for the operating model, the ways of working, and talent management of the Compliance function in Genentech (including recruiting, developing, supporting and managing a team of high performing individuals, providing guidance and coaching to develop the team’s skills and knowledge).
• Serve as the subject matter expert for the organization in compliance matters as the enterprise-wide Chief Healthcare Compliance Officer, driving and actively contributing from compliance perspective to any local initiatives as well as overseeing the development, review, updating, and implementation of compliance programs along with policies, procedures, business practices, and guidelines that are compliant with state and federal laws and regulatory requirements.
• Oversee the team accountable for policy, training, compliance advisory services, compliance funding review of grants, sponsorships, donations, advisory boards, speaker programs and federal and state transparency requirements.
• Lead the use and implementation of an ethics/compliance reporting system for employees to report concerns and obtain assistance.
• Oversee the assurance team including the audit, monitoring, compliance investigations and Risk in Genentech, as applicable.
• Respond to alleged violations of law, rules, regulations, policies, procedures and the Code of Conduct, and ensure proper reporting of violations (or possible violations) in accordance with law and regulatory requirements, as well as Genentech and Roche internal processes. Where applicable, support the assessment and implementation of disciplinary measures.
• Proactively work with stakeholders to recognize and analyze the root cause of non-compliance, or specific challenges and concerns about achieving compliance in order to identify appropriate remediation measures or solutions for the organization to implement.
• Maintain the records documenting Genentech’s compliance-related activities, including, but not limited to audits, investigations, and compliance-related training and education.
• Work in strong partnership with the Chief Compliance Officer, the Pharma Compliance Office and with other members of the Roche Compliance community, specifically peers in the North American affiliates, to ensure a consistent and effective compliance program within the larger Roche enterprise and foster a oneRoche Approach, when applicable.
• Contribute to good relationships with regulatory/industry bodies, raise the standards for ethical business, promote regulatory convergence, and increase digital health readiness.
• Participate in relevant business sustainability governance bodies (inside / outside of Genentech and Roche Pharma).

Qualifications and Experience

• A United States law degree (J.D.) from an accredited institution
• A minimum of 15+ years of direct U.S. compliance experience in a Compliance department of a large biotech/pharmaceutical company
• At least 8 years of experience leading/transforming a team and successfully managing and developing people, ideally including management of people managers
• Substantial working knowledge of U.S. healthcare and regulatory law
• Specific Skills/Expertise: Highly engaged and decisive business leader with high ethical and integrity standards. Demonstrated knowledge and understanding of the healthcare compliance and regulatory environment including the Anti-Kickback Statute, with an in-depth understanding of the applicable Safe Harbors, False Claims Act, FDCA, FTC, and other applicable federal and state healthcare laws, regulations, guidance, and policy, as well as in emerging areas of AI.
• Strong executive presence and gravitas with the skills to influence and inspire others
• Outstanding interpersonal skills, including establishing rapport, building trusted relationships, and engendering confidence at all levels of the organization
• Excellent judgment, particularly in determining the significance of compliance matters; effectively measuring, minimizing, and mitigating risk; and in evaluating risk within the context of other business considerations
• Prominent leadership and managerial abilities with an established record of accomplishment of success and achieving results
• Demonstrated success in establishing a high performing environment with an excellent reputation attracting the best talent, developing and inspiring them
• High integrity and objectivity with excellent interpersonal skills and the ability to communicate and interact diplomatically, flexibly, and effectively at all levels of a complex, multinational organization
• Able to serve as a trusted counselor, with a proven ability to advise and counsel on strategic or sensitive issues
• Personal credibility and the ability to articulate positions and strategies concisely, with a practical focus
• Maintain confidentiality of sensitive information and demonstrate the highest integrity in all settings
• Excellent listening skills and the ability to appreciate diverse positions and achieve consensus
• Willingness and ability to deliver a consistent message in the face of pressure or adversity
• Ability to encourage transparent and connected culture between the Legal and Compliance Department and business stakeholders
• An aptitude for utilizing and learning new technologies, such as AI, in how we work