VP Medical ELMAC

Please DO NOT apply, only for testing purposes.

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

The Regional Head is the Regional Medical Organization Leader and single point of Medical accountability and matrix leadership and will provide overall leadership to and directly manage the medical affairs organization in the region including all operational, strategic, and personnel management aspects. The successful candidate will lead the medical strategies to support access of marketed products through leadership, insights and delivery of medical activities.

What you will do

Let’s do this. Let’s change the world. In this vital role you will:

• Provide strategic insight, direction, and approval to patient-focused medical strategiesthat maximize the value proposition of Amgen's therapies including annual strategic planning and goal setting, launch support and lifecycle management, in collaboration with appropriate cross-functional teams and governance, ensuring alignment across region/global
• Partner with cross functional stakeholders to shape the healthcare ecosystem by enabling access to medicines through evidence generation, communication and education of medical and economic value
• Provide strategic input into key, high-impact insights and ensure robust staff competency
• Foster and enhance collaboration and coordination across Medical
• Provide strategic input to stakeholder mapping and engagement plan for region
• Lead relationships with external healthcare community, including interactions with opinion leaders, payers, societies and industry associations for scientific exchange as Amgen's top regional medical representative
• Drive regional strategy, governance, development, prioritization, execution and performance of evidence generation portfolio
• Foster Amgen‘s reputation as a science-based, innovative and patient-focused reliable partner
• Provide strategic input into advocacy strategies and lead relationships as appropriate
• Partner with Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities, ensure human subject safety in partnership with responsible functions (eg, (e.g., Global Regulatory Affairs and Safety, Global Development), and ensure communication of the implications to internal/external stakeholders, serve as regional escalation for safety/quality issues and provide clinical oversight of product safety evaluation at the regional level
• Chair/Member and Medical representative of relevant leadership, governance and cross functional teams (eg, Regional KEG, Regional Leadership Team)
• Develop budget and departmental resourcing strategy in collaboration with cross-functional stakeholders and key business partners
• Recruit, retain, coach, mentor, motivate and develop talent
• Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
• Ensure appropriate medical staff training
• Accountable for appropriate clinical trial conduct in the region (eg, overseeing clinical trial priorities, ensure goals are met, including site recruitment and subject enrollment predictability). In US, direct oversight for Development Operations (eg Site Management)
• Provide strategic input into labels/regulatory/reimbursement/policy/promotional and medical deliverables used to support internal/external interactions
• Ensure scientific/medical subject matter appropriateness of labels/regulatory/reimbursement/policy/promotional and medical deliverables (eg, slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process
• Resolve portfolio level risk and issues across Regional Medical
• Provide strategic input into data interpretation and analysis, as appropriate
• Provide decision on IME, Donations, medical grants and sponsorships, where appropriate
• Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement
• Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies.
• With advise from cross-functional Leadership Team, ensure informed budget/resource trade-offs across regional portfolio
• Develop and execute Medical staff engagement plan
• Direct medical teams in navigating products through internal governance and external regulatory interactions as appropriate
• Ensure scientific/clinical oversight for due diligence in partnership with Business Development and ensure support for partner relationships
• Partner with Regulatory and Global Development to ensure local needs are met

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek is a collaborative, strategic and exceptional people leader with these qualifications:

• Doctor of Medicine (MD)
• 10 years of medical affairs or clinical development experience, 7 years of which should be from a pharmaceutical or biotechnology company
• 8 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Track record of executive management
• Experience with clinical study management and conduct
• Track record of experience in pharmaceutical product development, product lifecycle and commercialization process knowledge/proven experience with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
• Extensive experience working in a product launch environment
• Documented broad medical and scientific experience
• Finance and budgeting experience, resource management experience
• Extensive knowledge of regulatory affairs and drug safety
• Knowledge of regional pharmaceutical industry and legal/health system environment
• Extensive network of customer/industry contacts

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.