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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. Amgen helped to develop the science used in making biologic medicines, and we remain a leader in designing and manufacturing new biologics. This expertise is now being applied to the challenge of making high-quality Oncology Biosimilars.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as Global Development Leader (GDL) for clinical development of key assets and be responsible for Biosimilars in the Amgen portfolio. The GDL represents the unified global medical voice and is the single point of accountability for evidence generation and scientific communication. The GDL is also responsible for developing and executing the global scientific/medical evidence plan, collaborating cross-functionally and globally to integrate medical, scientific, and commercial input into the program and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, and Commercial outputs.

Key Responsibilities

• Oversee activities related to planning for studies across the product lifecycle for biosimilars portfolio

• Interpret and integrate the results of research programs (e.g., study data, competitor data, publications) into the program strategy

• Deliver input to regulatory and safety groups for queries from regulatory agencies and negotiate with these group

• Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, protocols, clinical study reports, publications, and reimbursement submissions)

• Issue strategic medical input into all aspects of the Commercialization process (pre-clinical through launch)

• Approve medical/scientific elements of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs

• Communicate safety and efficacy/effectiveness status of the product internally and externally

• Review, approve, and execute product specific publication plan as development lead

• Manage the development and execution of global Biosimilars medical plan and regional partnerships

• Guide the development and execution of global publication plan

• Provide medical support for licensing activities and support partner relationships as needed

• Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions

• Collaborate on multidisciplinary product team with the Commercial Lead, Regulatory Lead, and Operations Lead

• Mentor, coach, and supervise the performance of direct reports

• Provide oversight and ensure alignment between clinical development and development operations.

• Supply medical/scientific support to other functions as appropriate

• Support regional needs for medical/scientific evidence generation

• Develop key relationships with global opinion leaders

• Development and execution of clinical trials

• Experience in a variety of therapeutic areas

• Familiar with investigators or institutions in various therapeutic areas

• Experience with regulatory affairs and drug safety as well as publications, commercialization and business practices

• Leading and motivating staff in a complex, multi-functional matrix environment

Win

What we expect of you

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

Basic Qualifications

• MD or DO degree from an accredited medical school AND

• Five years of industry or academic research AND

• Six years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resource

Preferred Qualifications

• Accredited fellowship in relevant specialty or sub-specialty (e.g., oncology, hematology, internal medicine, rheumatology, gastroenterology, dermatology, ophthalmology), board certified

• Eight or more years of industry research experience

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO Company)

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 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.