Combination Product Safety Medical Director

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Combination Product Safety Medical Director

Live

What you will do

Let's do this. Let's change the world. In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for the assigned combination product(s) by establishing the strategy, direction, and priorities of patient/user safety activities and will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned product(s). The Combination Product Safety Medical Director will assess potential impact of quality findings on patient/user safety for all clinical and commercial products in conjunction with members of the Global Safety Team; provide clinical input for combination product scientists; guide combination product safety data collection/analysis/reporting, and lead combination product risk management activities.

Key Activities:

• Assess and manage combination product safety issues
• Create input for combination product risk management documents (hazard analysis, user risk assessments, human factors, etc.) for clinical and commercial products
• Create reportability assessment activities take place for device complaints/malfunctions
• Provide clinical input in the development and maintenance of digital health technology assets
• Provide medical oversight to CPS staff for the combination product risk/benefit analyses
• Provide clinical input for medical evaluations
• Inspection readiness - Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness and acts as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

In addition to the above, the Combination Product Safety Medical Director will perform management activities for direct reports including mentoring, career development, and training as well as other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor.

The Combination Product Safety Medical Director will bring a strong strategic approach; effective leadership, influencing and negotiation in a cross-functional, matrix environment; and deep experience in team management and conflict management. The ideal candidate will have the following key competencies:

• Processes and regulations for pharmacovigilance and risk management in addition to combination products and stand-alone devices
• Advanced understanding of interfaces across various pharmacovigilance and risk management processes
• Drug/device development and lifecycle management
• Safety data capture in clinical development and post-market settings
• Safety database structure and conventions
• MedDRA and other dictionaries used in pharmacovigilance and device reporting
• Methods of qualitative and quantitative safety data analysis
• Product and disease state knowledge
• General medicine, epidemiology, physiology, and pharmacology
• Internal organizational and governance structure
• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling

The Medical Director will have the following Pharmacovigilance skills:

• Signal detection and evaluation
• Aggregate data analysis
• Good clinical and scientific judgment
• Application of medical concepts and terminology
• Document writing and source document review
• Data interpretation and synthesis
• Basic skills in application of statistical and epidemiological methods to pharmacovigilance
• Ability to convey complex, scientific data in an understandable way
• Ability to analyze and interpret complex safety data
• Advanced skills in application of statistical and epidemiological methods to pharmacovigilance

While this position is based at our main headquarters in Thousand Oaks, California, other locations may be considered.

Win

What we expect of you

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

• Basic Qualifications: MD or equivalent degree from an accredited medical school with 5 years' experience in drug safety (3 years' combination product safety experience) AND completion of an accredited medical or surgical residency OR clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Preferred Skills: Product safety in the bio/pharmaceutical industry or regulatory agency and previous management and/or mentoring experience

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.

• Vast opportunities to learn and move up and across our global organization
• 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

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.

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.