Global Safety Medical Director - Global Safety Officer, Oncology

Global Safety Medical Director

Let’s do this. Let’s change the world. In this vital role the Global Safety Medical Director serves two vital roles for the therapeutic area: Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The role is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. 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 Global Safety Medical Director also is a member of the Evidence Generation Team. They will be assigned as delegate for the TAH as needed and has management of Global Safety Physicians.

• 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 Global Safety 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

What You Can Expect Of Us

• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
• The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
• In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

Sponsorship

• Sponsorship for this role is not guaranteed.

About Amgen

• 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, disability status, or any other basis protected by applicable law.