Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will improve patient lives through leadership of the Regulatory Affairs for the therapeutic area of Oncology. In this role, the Vice President will provide expertise for the development, registration, and lifecycle management of all our Oncology molecules.  As well as strategic regulatory influence locally and globally in addition to the development of successful, expedient, and innovative regulatory strategies for development and approval of Amgen products.

Responsibilities

• Develops the vision of the Regulatory Therapeutic Area for Oncology and drives its execution, ensuring the globalization of strategy and process

• Represents the Regulatory Affairs Therapeutic Area (TA) with Amgen executive leadership, governance bodies, regulatory agencies, and external partners

• Has oversight of, and is accountable for, all aspects of Regulatory TA strategies, decisions, and implementation plans

• Provides timely input to Amgen executive leadership, review committees and other cross-functional product meetings

• Advocates for Regulatory Affairs by building strong relationships with key external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally

• Provides strategic vision to guide the development of new department and cross-functional processes including technology and compliance initiatives

• Exchanges regulatory information with other Global Regulatory Affairs and Strategy (GRAAS) leaders on an ongoing basis (e.g., prior to relevant senior management review committees and governance boards)

• Prioritizes projects within the TA to meet Corporate and R&D priorities

• Accountable for defining and delivering against TA goals and objectives, aligned with corporate, R&D, and GRAAS goals

• Reviews and approves alignment of sub-functional goals in RA

• Provides managerial leadership and direction to functional heads to facilitate issue resolution and allowing for appropriate prioritization or resources to achieve goals

• Ensures staff are compliant with Amgen corporate and departmental training and SOP review

• Provides coaching, mentoring, and development of staff

• Recruits and retains regulatory professionals and assist in the recruitment of talented GRAAS and AMGEN staff

• Develops meaningful TA goals in alignment with department goals

• Envisions and builds an organization and processes that support future department, company, and industry changes

• Responsible for TA budget and headcount

• Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes

• Develops plans for staff created annually and reviewed quarterly

• Conducts regular functional governance meetings

• Responsible for thorough staff and organizational development including effective Talent Management, Succession Planning and Maximizing Amgen Potential (MAP) Process

• Responsible for organizational management through ERP tools, expense report reviews, invoice approvals, timecard review and approval, overtime approval, vacation requests, etc.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree & 8 years of regulatory affairs experience OR

• Master’s degree & 10 years of regulatory affairs experience OR

• Bachelor’s degree & 12 years of regulatory affairs experience AND

• 8 years of direct managerial experience. Previous experience managing other managers

Thrive

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.

• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Amgen’s Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

Consistent with our core leadership value of “Develops the Best Team,” we are seeking leaders that prioritize the development of talent. As a manager, your priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:

• Mentoring, coaching, and developing staff to build highly skilled, diverse, and inclusive teams

• Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities

• Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business

• Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement

• Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages

• Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans

• Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives

• Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting

• Identifying diverse, qualified successors for key positions

• Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.

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.

MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients.  And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.

INNOVATIVE: Stretch yourself at the cutting edge. You’re poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.

REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.

COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

REWARDING. Get a fair share in success. Everyone’s contribution is recognized – and strong performance is rewarded.

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance.  Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.