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Global Safety Medical Director - Hematology/Oncology

Amgen
Amgen
0-2 years
243,245.00 USD - 319,267.00 USD
10 Nov. 5, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Global Safety Medical Director – Hematology/Oncology

Location: United States (Remote)
Job ID: R-229267
Category: Safety
Work Type: Remote
Date Posted: October 31, 2025
Salary Range: USD 243,245 – 319,267


About Amgen

At Amgen, you’ll be part of something greater — a shared mission to serve patients living with serious illnesses.

Since 1980, Amgen has pioneered biotechnology innovation, tackling some of the world’s toughest diseases. With a focus on four key therapeutic areas —

  • Oncology

  • Inflammation

  • General Medicine

  • Rare Disease

Amgen reaches millions of patients worldwide through research, manufacturing, and delivery of life-changing therapies.

Our culture is collaborative, innovative, and science-driven. If you’re passionate about using your expertise to make a lasting impact, join Amgen and transform lives — including your own.


Role Overview

As Global Safety Medical Director – Hematology/Oncology, you will play a critical leadership role in managing global product safety for Amgen’s Hematology-Oncology portfolio.

You will lead Global Safety Operations (GSO) teams to ensure full compliance with worldwide pharmacovigilance regulations and support the establishment of an effective global safety organization.

This role provides direct accountability for the safety profile, signal management, and product-related safety decisions for assigned products.


Key Responsibilities

Leadership & Safety Oversight

  • Manage staff and allocate resources within Global Patient Safety (GPS).

  • Lead Safety Analysis Team (SAT), Global Safety Team (GST), and act as a core member of the Executive Safety Committee (ESC).

  • Represent the GSO as part of the Evidence Generation Team and other cross-functional groups.

  • Serve as delegate for the Therapeutic Area Head (TAH) as required.

Safety Governance & Risk Management

  • Validate and lead safety signal assessments.

  • Develop and maintain Core Safety Information (CSI), including data sheets and core risk language for informed consent.

  • Prepare and review Risk Management Plans (RMPs) and ensure effective risk minimization strategies.

  • Oversee periodic aggregate safety reports and ensure compliance with global regulatory timelines.

Regulatory and Clinical Support

  • Provide safety input into clinical trial protocols, statistical analysis plans, and clinical study reports.

  • Review safety sections of regulatory submissions such as NDAs and global filings.

  • Support inspection readiness and ensure documentation aligns with regulatory expectations.


Basic Qualifications

  • MD or DO degree from an accredited medical school
    AND

  • Completion of an accredited medical or surgical residency, OR

  • Clinical experience in an academic or hospital-based practice setting


Preferred Qualifications

  • Experience in product safety within the biopharmaceutical industry or regulatory agency

  • Leadership or mentoring experience in pharmacovigilance or clinical safety

  • Background in Oncology—study, research, or treatment of hematology/oncology disease states


What You Can Expect from Amgen

Amgen is committed to your professional growth and personal well-being, providing support every step of your career.

Our Total Rewards Plan includes:

  • Competitive base salary plus annual bonus or incentive plan

  • Comprehensive benefits package, including:

    • Retirement and Savings Plan with company contributions

    • Group medical, dental, and vision coverage

    • Life and disability insurance

    • Flexible spending accounts

  • Stock-based long-term incentives

  • Award-winning time-off programs

  • Flexible work models (remote and hybrid options)

  • Career development and continuing education opportunities

Actual salary will depend on skills, experience, and qualifications.


Additional Information

  • Application Deadline: None. Applications are accepted until the position is filled.

  • Sponsorship: Not specified; inquire directly if applicable.


Diversity & Equal Opportunity

Amgen fosters an inclusive, ethical, and diverse work environment, where everyone is valued and respected.

We are an Equal Opportunity Employer, considering all qualified applicants without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

Reasonable accommodations are available during the application and interview process.


How to Apply

Be part of a mission that transforms lives through science and compassion.

🔗 Apply Now: careers.amgen.com
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