Associate Legal Director, Italy and Benelux

This role is considered Hybrid.

Overview

As the company continues to grow, Alnylam Italy is seeking an experienced Legal Counsel based in its Milan office and who will be responsible to support Alnylam’s business as its primary legal point of contact and trusted business partner.

This role will join the Legal International Team and represent Legal in the relevant Leadership Teams. The role will report to the Executive Legal Director, International Commercial, based in Switzerland, and work closely with the Country Managers responsible for Italy and Benelux respectively. As a business partner and facilitator of legal compliance, the Legal Counsel Italy and Benelux is a hands-on and resourceful professional who will contribute to growing a top-tier, innovative, patient centric, multinational biopharmaceutical company.

In this capacity, the successful candidate will be accountable and have direct responsibility to provide with high quality and timely strategic and operational legal direction in all areas of the affiliate’s business, from last mile product Distribution to local pricing and reimbursement and access, materials review, customer facing activities, implementation of Global/Regional patient finding strategy at a local level, Patient Support Programs and Country specific corporate and employment matters and to work closely with the Compliance team on local compliance issues, including data privacy.

As a key member of the Legal International Team, the role will interact frequently with Legal and Compliance colleagues in the Company Corporate Headquarter and other Regions, to share ideas and best practices and may be involved to contribute to legal projects, issues and priorities across the International region, as identified from time to time by the Executive Legal Director, International Commercial.

The successful candidate will strongly identify with Alnylam’s and the Legal Team’s mission, vision and values: they are self-motivated and enthusiastic team players, eager to learn and invested in enhancing team’s effectiveness. They are purpose driven and result oriented, embrace a culture of trust and candor, take the initiative and are open to new ideas.

The ideal candidate is an Italian-qualified lawyer fluent in both Italian and English, with a broad-based knowledge of the laws and regulations governing biopharmaceutical companies activities and compliance, gained in another biopharmaceutical company (experience in a company focused on rare disease medicines would be a plus) or the healthcare team of a leading law firm. Education or direct experience in other jurisdictions is a also plus.

Summary of Key Responsibilities

1. As a key partner to the business, the Legal Counsel Italy and Benelux is the key legal point of contact and accountability for the Italy and Benelux teams and has full empowerment to:

• Provide pragmatic and timely strategic and operational counsel to the relevant Management on local legal, compliance, transactional and commercial issues, as well as on any local matters relating to medical affairs, pharmacovigilance, R&D, quality and supply chain activities and requirements.
• In that regard, draft and review proposed business/legal arrangements and contracts for the relevant expertise areas in the countries of responsibility;
• Advise on local labour issues and negotiate with external parties on behalf of the Company, where needed or appropriate, in coordination with the Employment Law Global Counsel and HR teams and support preparation and review of legal documentation as required;
• Review product related and disease awareness materials, advise on appropriate strategy and language for scientific, commercial and business documentation and communications according to local laws and Company standards, ensure local legal support to local pricing and reimbursement and access activities and new product launches;
• Provide advice and legal support on application and maintenance of all authorizations, permits, licenses, contracts and communication needed for local operations, including importation, manufacturing and marketing of products and implementation of product recalls where needed;
• Assist as necessary with corporate secretarial matters and ensure compliance with local regulatory requirements;
• Assist Compliance with the interpretation of Alnylam global, regional and local policies and procedures and help ensure compliance by local teams;
• Assess, supervise and manage external legal counsels as appropriate and in line with the budgets provided, ensuring advice is timely, cost-effective and consistently of high quality.

2. As a member of the Legal International Team and Global Legal Expertise Area, the Legal Counsel is expected to:

• Proactively identify emerging legal and compliance risks in Italy and Benelux, develop and lead appropriate plans to address and manage the risk;
• Monitor changes and developments in the local legal and regulatory environment, keep regional/local management and other Legal and Compliance colleagues apprised of significant developments and trends;
• Partner closely with the Executive Legal Director, International Commercial and other members of the Legal organization to identify and advance business priorities, projects and share ideas and best practices;
• Actively lead or contribute to legal projects, issues and priorities as identified from time to time by the Executive Legal Director, International Commercial, and collaborate with other Legal colleagues to ensure alignment with Regional and Global strategy and goals;

• Contribute to enhance Legal team alignment and effectiveness and to determine and pursue team’s goals and outcomes.

Qualifications

• Law Degree and significant working experience in the pharmaceutical industry, (experience in rare diseases, in both law firms and an inhouse counsel, highly valued).
• Italian and English written and spoken, additional fluency in other languages, such as French or Dutch, a plus;
• Hands-on, proactive and enthusiastic, with demonstrated ability to partner cross-functionally and collaboratively with the business and with international colleagues in the US and Europe, across different Expertise Areas;
• Broad based knowledge of general corporate law and regulatory law impacting the pharmaceutical industry, especially as related to the commercialization and promotion of pharmaceutical products, and in the review of promotional and non-promotional materials;
• Solid judgment and business acumen and understanding of business operations, particularly in determining the significance of legal matters in the context of business objectives, assessing risks and benefits and providing innovative business and legal solutions;
• High level of integrity of confidential and sensitive information and credibility within the organization:
• Self-motivated and efficient, able to proactively identify short and mid-term business needs, to develop strategies and to manage responsibilities independently, with strong organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously;
• Able to work accurately with an appropriate sense of urgency and function effectively and efficiently in a fast-paced and dynamic environment;
• Strong verbal and written skills with ability to explain complex, challenging issues in a clear manner to all levels of the organization, including senior management;
• Strong interpersonal skills, including diplomacy and flexibility, and the ability to interface effectively throughout all levels of the organization as well as with external parties, and adaptable to circumstances and variety of cultures;
• Ability to manage and work with outside counsel and appropriately assess when consultation with outside counsel is appropriate.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.