Global Safety Medical Director, Rare Disease

Career Category

Job Description

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. 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 Officer, Medical Director, Rare Disease

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as the safety expert of the assigned product(s) within the Rare Disease portfolio.

You will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).

Serve as a member of the Evidence Generation Team and other relevant cross-functional teams and will be assigned as delegated for the Therapeutic Area Head (TAH).

Work in a fast-paced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.

Key activities:

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness
• Domestic and International travel up to 10%

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Global Safety Officer we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Safety experience

OR

Master’s degree and 7 years of Safety experience

OR

Bachelor’s degree and 9 years of Safety experience

Preferred Qualifications:

• Product safety in the bio/pharmaceutical industry or regulatory agency
• Expertise in Rare Disease therapeutic area, or clinical training.
• Experience with marketed product safety; risk management
• Experience with phase 1-3 clinical trials safety assessments and analyses
• Drug Submission experience
• Leadership experience of the safety profile of products assigned with cross-functional team members.

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, includin