Executive Medical Director, Combination Product Safety

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds 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

Lets do this. Lets change the world. In this vital role the Executive Medical Director will provide science-based evaluation of product quality and device, companion diagnostic and digital health safety issues for Amgen products.

Responsibilities

• Assess the potential impact of quality findings on patient/user safety for all clinical and commercial products

• Review adverse event data to detect potential product quality issues for commercial products

• Have expertise in combination product safety data collection, analysis and reporting in clinical trials. As well as post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit/risk analyses

• Engage as a Safety expert in the therapeutic area and be accountable for the safety strategy, and major safety deliverables of the combination product therapeutic area

• Manage therapeutic area safety teams and be accountable for the staff management and resource planning/allocation

• Participate as a core member of Global Patient Safety (GPS) and Leadership Team to support the GPS, Vice President in the establishment of a highly effective global safety organization that will be in full compliance to worldwide regulations for combination products

• Lead all CPS (Combination Product Safety) staff in the assessment and management of combination product safety issues

• Lead CPS staff input to combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products

• Ensure that CPS staff report assessment activities that take place for device complaints and malfunctions

• Lead and provide medical oversight to CPS staff in the authoring of combination product risk/benefit analyses

• Provide clinical input in the development and maintenance of digital heath technology assets

• Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness

• Act as the representative and point of contact for Health Authority Inspections and Internal Process Audits

• Perform management activities for direct reports, including mentoring, career development, and training, 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

• MD or DO from an accredited medical school AND

• Five or more years of in industry and/or academic clinical research AND

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

Preferred Qualifications

• At least 5 years of experience with pharmaceutical/biotechnology/device pharmacovigilance/risk management

• Knowledge of global regulatory requirements, standards, and guidances for pharmacovigilance/ risk management in relation to combination products and standalone devices

• An understanding of device risk management methodology, tools, and terminology; including human factors engineering methodology

• Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products

• An understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes

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

Amgens 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 organizations 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. Youre 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. Everyones 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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 based on 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

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, Puerto Rico and Canada 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.