The HTA Biosimilars Director position has a global scope and is based in Amgen’s HTA Center of Excellence. The Amgen HTA CoE reports up through the SVP of Global Value Access & Policy in Amgen and this role reports directly to the Head of the HTA COE.
The incumbent will play a critical role in optimizing the success of the biosimilar portfolio (currently 12 molecules) at Amgen, a new and unique business model added to Amgen’s portfolio.
Specifically, this role will:
• Ensure a clear understanding of submission requirements across all countries, translate those requirements into actionable submission plans, lead the creation of core guidance documents for core materials (e.g., Global Value Dossier (GVD) and Objection Handler)
• Ensure biosimilar product-specific GVDs align with country submission needs, and lead the development of product-specific Objection Handlers.
• Leverage their biosimilars expertise to help with the interpretation of what is required from a submission standpoint in markets that do not have clear guidance and help inform biosimilars launch and submission strategy
• Partner with affiliates and regional stakeholders to secure clarity on central resource needs, core deliverables and key milestones, and leverage these insights to build and implement a robust work plan in collaboration with the HTA Biosimilars Project Manager and the Modeling COE
• Partner with global leads to ensure core materials meet affiliate needs, are of high quality and are delivered in a timely manner
• Support affiliates in the preparation of submissions (e.g., dossiers, executive summaries or other submission content) of adequate quality to secure optimal access and reimbursement, and ensure appropriate documentation and governance is in place and content is “audit-ready”
• Leverage relevant learnings and insights to establish Amgen’s approach to managing national submissions for biosimilars for optimal access and reimbursement.
In addition, this role will:
• Support recruitment efforts
• Managing budget and resources
• Adhere to all Amgen Policies, SOPs and other controlled documents
• Champion opportunities to be impactful
• Lead/coordinate initiatives to improve processes within GHE/HTA COE and Amgen
Travel expected approximately 25% international
• Doctorate degree and 4 years of health economics, access and/or reimbursement experience?OR
• Master’s degree and 8 years of health economics, access and/or reimbursement experience?OR
• Bachelor’s degree and 10 years of health economics, access and/or reimbursement experience
• 4+ years of experience in global health economics and outcomes research including submissions, objections, and strategy for biosimilars reimbursement or similar experience.
• Prior experience with launch(es) of biosimilars or relevant and transferable experience in launching biopharmaceutical products in global markets
• PhD, PharmD, or Masters in Health Economics, Outcomes Research, Health Services Research, or related field.
• Have worked on external dossier submissions with respect to content creation, editing and/or review – ideally HTA /reimbursement dossiers or similar submissions.
• Have worked with customers and colleagues based in different time zones
• Self-motivated and able to advance projects without supervision
• Strong presentation and communication skills
• Experience working in a global, matrixed organization
• Strong leadership attributes and deep critical thinking and problem solving skills and ability to help bring key issues to resolution.
Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen's outstanding compensation package features comprehensive benefits. To learn more about this opportunity and to apply, please visit us online at http://careers.amgen.com/ and search job #R-35161.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.