Policy Director

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

This role reports to the leader of Global Regulatory and R&D; Policy and may include significant domestic and international travel to support internal and external policy activities. The successful candidate is a subject matter expert and will engage other subject matter experts across Amgen and externally to develop and advance policy issues aligned with Amgen goals and priorities.

* Leading and/or participating in the development and articulation of Amgen's positions on biosimilar and regulatory policies that impact Amgen's business * Identifying and anticipating resource needs and fulfilling those needs by developing those resources through research, analysis, and writing. * Monitoring, analyzing and anticipating changes in the regulatory, scientific and business environment to identify and forecast strategic regulatory issues and other opportunities to advance sound scientific regulatory and broader biosimilar policy * Leading and/or engaging on cross-functional teams to establish priorities and develop and execute strategic and long-term advocacy plans for the advancement of Amgen’s policy goals * Advising and assisting executive leadership to ensure Amgen’s regulatory and R&D; policy positions and interests inform business cross-functional policy decisions and implementation * Providing internal stakeholders (e.g., GGA, GVA&P;, R&D;, Commercial, Legal) with a strategic regulatory and R&D; policy perspective * Providing strategic policy guidance to cross-functional teams & Product Teams * Engaging regulatory authorities at the policy level * Fostering a reputation with regulators as being science-based, reliable and trustworthy by advocating sound regulatory and safety policy * Developing and leveraging stakeholder relationships internally (e.g. Global Government Affairs, Global Value, Access & Policy, GRAAS colleagues globally) and externally (e.g., FDA, national competent authorities, industry associations and other and both industry and non-industry stakeholders) to advance Amgen's positions related to regulatory and R&D; policy * Working with State Government Affairs to coordinate biosimilars legislative initiatives, develop data-based tools in support of those initiatives, and find greater common ground with other stakeholders. * Monitoring and analyzing regulatory and other governmental policies and their impact to Amgen policy strategy. * Representing Amgen as a subject matter expert in public forums and in meetings with policymakers and stakeholders * Supporting global biosimilars cross-functional team of professionals and regional biosimilars teams or initiatives

**Basic Qualifications:** * Doctorate degree & 4 years of Regulatory, biotech/pharma industry or policy experience * OR Master’s degree & 8 years of Regulatory, biotech/pharma industry or policy experience * OR Bachelor’s degree &10 years of Regulatory, biotech/pharma industry or policy experience **Preferred Qualifications:** * Skill in building and leveraging relationships with industry stakeholders (e.g., trade associations, biopharmaceutical companies, regulatory authorities * Proven ability to navigate complex organizations * Experience in public policy development and advocacy * Experience in a government agency * Experience as a health care provider or patient advocate