Combination Product Safety Medical Director, US- Remote

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Combination Product Safety Medical Director

Live

What you will do

Group Purpose

• Provide science-based evaluation of product quality and combination products, stand-alone devices, diagnostics and digital health safety issues for Amgen products
• Assess of potential impact of quality findings on patient/user safety for all clinical and commercial products
• Review of adverse event data to detect potential product quality issues for commercial products
• Provide expertise in combination product safety data collection / analysis / reporting in clinical trials, post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit / risk analyses

Job Summary

The Combination Product Safety Medical Director is the safety expert for assigned combination product this includes:

• Assessment of 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
• Provision of expertise for combination product safety data collection/analysis/reporting
• Provision of expertise for combination product risk management activities

Key Activities

Combination Product Safety

• Assesses and manages combination product safety issues
• Creates input for combination product risk management documents (hazard analysis, user risk assessments, human factors, etc.) for clinical and commercial products
• Creates reportability assessment activities take place for device complaints/malfunctions
• Provides clinical input in the development and maintenance of digital health technology assets
• Provides medical oversight to CPS staff for the combination product risk/benefit analyses
• Provides clinical input for medical evaluations

Inspection Readiness

• Undertakes activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Acts as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• General
• Performs management activities for direct reports including mentoring, career development, training, etc.
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Knowledge and Skills

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

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

Other skills

• Strategic thinking
• Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment
• Big picture perspective and context analysis
• People and team management
• Conflict management
• Organization, prioritization, and planning of work
• Project management
• Critical scientific assessment and problem solving
• Oral presentation skills
• Written communications and medical/scientific writing
• Computer skills (e.g., MS Office Suite and safety systems)

Competencies

KNOWLEDGE

• Serves as a technical authority within the organization
• Develops advanced/leading-edge technologies and/or concepts that have global reach and applicability

Problem solving

• Applies global thought leadership
• Shapes long-term strategic direction and reputation of Amgen
• Provides authoritative advice to top management
• Leads organizational invention at a global level

Autonomy

• Models organizational standards for innovation
• Directs projects of critical importance to Amgen

Contribution

• Serves as expert advisor to top management and is a sponsor for large-scale projects
• Ensures products and services are aligned with current and future needs and expectations including the following:
• Business needs
• Medical field
• Research community
• Creates solutions that enhance Amgens intellectual property

Win

What we expect of you

Education & Experience (Basic)

• MD or DO degree from an accredited medical school

• Completion of an accredited medical or surgical residency
• 5 years experience in drug safety
• Significant (3 years+) experience with combination product safety

Education & Experience (Preferred)

• MD, DO, or equivalent degree from an accredited medical school

• 4 years of directly related experience OR MD of a foreign medical school

And

• Product safety in the bio/pharmaceutical industry or regulatory agency
• Previous management and/or mentoring experience
• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

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

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 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.