Career CategorySafety
Job DescriptionGlobal Safety Medical DirectorWhat you will doLet'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.
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
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 usAs 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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range256,606.50USD -347,173.50 USD
