Amgen

Global Safety Medical Director - Global Safety Officer - Oncology

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 21, 2019
Ref
R-82115
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global Safety Officer (GSO) serves 2 roles:

1) Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

2) The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). These are cross group collaboration teams. The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Physicians.

KEY ACTIVITIES

Product safety profile, benefit-risk evaluation, and risk communication

Clinical trial safety

Brochure and Informed Consent Form

New drug applications and other regulatory filings

Risk management and minimization

Commercialization Process

Inspection Readiness

Partnerships and integration activities

Participate in safety agreement development and review process

Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement

Basic Qualifications

MD or DO degree from an accredited medical school

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 Qualifications

2+ years of industry PV experience

Oncology experience in early development.

Product safety in the bio/pharmaceutical industry or regulatory agency

Previous management and/or mentoring experience

Experience with oncology products/early development

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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.

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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.