Global Safety Medical Director - Global Safety Officer, Oncology

Amgen • Thousand Oaks, CA

1d

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Medical Director What you will do 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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior