Director, Compliance - Italy

Major, Lindsey & Africa, LLC; Lombardia; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Revolution Medicines seeks an experienced Healthcare Compliance lead for Italy to drive program development and regulatory alignment in a fast-growing oncology setting.

You will advise local Commercial and Medical teams, collaborate across regions to implement global initiatives, and oversee risk-based assessments, investigations, and third-party due diligence in Italy.

Qualifications

• 10 years’ relevant experience, including in-house pharmaceutical compliance
• Experience advising diverse stakeholders and scale-up of compliance capabilities
• Comprehensive knowledge of Italian anti-corruption and healthcare laws, transparency and disclosure requirements

Responsabilités

• Lead the continuous development of the Healthcare Compliance Program in Italy in line with global strategy
• Advise local Commercial and Medical teams on risk-based guidance across product life cycle
• Collaborate cross-functionally to implement global compliance initiatives in Italy
• Oversee reviews of HCP/HCO interactions and promotional materials for compliance
• Monitor regulatory developments in Italy and advise on operational impact
• Draft and update compliance policies and guidance in Italy
• Develop and monitor an Italian compliance training program for employees and third parties
• Foster a strong culture of compliance and integrity within the Italian organization
• Provide SME input on systems, tools, and technology for program efficiency
• Design risk assessment, monitoring and auditing plans for Italy and lead remediation
• Administer local whistleblowing channels and support investigations
• Own third-party due diligence and monitoring under anti-corruption requirements
• Support transparency reporting obligations and provide regular compliance reports
• Act as liaison with regulators and industry associations; respond to inquiries

Connaissances

10+ years experience

Stakeholder management

Regulatory compliance

Italian law knowledge

Risk-based analysis

Strong communication

Negotiation

Problem solving

Team collaboration

Description du poste

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.

Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Their people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold themselves to a high standard of rigor—all in service of patients.

Key responsibilities of this role include the following:

• Program Development and Strategic Alignment: Lead the continuous development of the Healthcare Compliance Program in Italy in line with RevMed’s global compliance strategy. Ensure the program is consistent with the values and principles of the organization and fit for purpose and complies with applicable Italian laws, regulations and industry codes.
• Local Business Advisory: Represent Compliance on the Italian Leadership team and serve as the primary compliance advisor to the local Commercial and Medical teams, providing risk-based guidance across the product life cycle to enable successful launches and commercialization.
• Cross-Functional Collaboration: Collaborate across functions and regions to adapt and implement global compliance initiatives in Italy.
• Activity Review and Certification: Provide compliance oversight of the review and approval of interactions with HCPs, HCOs, patient organizations, payors and government officials (including grants, sponsorships, speaker programs and advisory boards), and of the certification of promotional and non-promotional materials and meetings.
• Regulatory & Code Monitoring: Proactively monitor and interpret legal, regulatory and industry-code developments in Italy and advise the business on their operational impact.
• Policies and Procedures: Draft, implement and update compliance policies, procedures and guidance to ensure compliance with applicable laws, regulations and industry codes in Italy.
• Training: Develop, deliver and monitor a comprehensive compliance training program for employees in Italy, including field-based personnel, and designated third parties.
• Compliance Culture: Foster a strong culture of compliance and integrity across the Italian organization.
• Systems and Process Innovation: Provide healthcare compliance subject matter expertise in developing compliance systems, tools and technology solutions that improve the efficiency and effectiveness of the program for common HCP interactions.
• Monitoring, Auditing and Risk Assessment: Design and execute the risk assessment, monitoring and auditing plan for Italy in collaboration with the Head of Compliance, and lead remediation where necessary.
• Investigations and Speak-Up: Administer local whistleblowing channels and support the Head of Global Compliance in compliance investigations, including corrective and preventive action plans.
• Third-Party Risk Management: Own risk-based due diligence and ongoing monitoring of third parties (distributors, agencies, consultants and vendors) under applicable anti-corruption and transparency requirements.
• Reporting and Transparency: Support the Compliance Committee and transparency reporting obligations, and provide regular compliance reports to the Compliance Committee, Commercial Leadership, Medical Affairs and country management.
• Stakeholder Liaison: Act as compliance liaison with Italian regulators and industry associations, managing responses to code complaints, inquiries and investigations.

Required Skills, Experience & Education

• 10 years’ relevant experience, including in-house pharmaceutical experience developing compliance programs.
• Demonstrated track record of working successfully as an individual contributor while managing a wide range of stakeholders and client groups, building compliance capabilities in a scaling organization without direct reports.
• Extensive experience with compliance matters relating to the development, approval and commercialization of pharmaceutical products in Europe.
• Comprehensive knowledge of Italian anti-corruption and healthcare compliance laws, transparency and disclosure requirements, and applicable industry codes.
• Ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.
• Strong critical thinking skills, attention to detail, adaptability, communication skills and professionalism.
• Ability to work in a matrix organization, collaborate with business partners, influence peers and interact with both senior management and Field Force, Medical and Market Access teams.
• Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations.
• Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings, as well as proven negotiation skills.
• Excellent organizational skills and problem-solving capabilities and the ability to perform in a fast-paced, high volume, deadline-driven environment.
• Confidence to advise stakeholders at all levels.
• Appropriate judgment to liaise with Legal and business colleagues and/or outside counsel as needed.
• Commitment to being a team player with the desire to be helpful in other areas covered by a growing Compliance department.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.