Global Safety Medical Director - Rare Disease (Early Development)

BioSpace; Washington (District of Columbia); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Flexible work models

Retirement and savings plan

Health, dental & vision coverage

Job summary

Amgen is seeking a Global Safety Officer, Medical Director for Rare Disease to drive safety strategy across early and late-stage assets. You will lead pharmacovigilance activities, govern safety decisions, and collaborate with cross-functional teams to support global development programs and post-marketing commitments.

You will oversee safety teams, provide strategic input on protocol design, safety monitoring, and regulatory interactions, while ensuring the highest standards of safety for

Qualifications

• MD or DO degree from an accredited medical school.
• Completion of an accredited medical or surgical residency.
• Clinical experience in either an accredited academic setting or private practice setting.

Responsibilities

• Lead safety strategy for early clinical development programs, including First-in-Human, dose-escalation, proof-of-concept, and Phase 1-2 studies.
• Provide medical safety input into clinical development plans and key decisions including dose selection and safety monitoring.
• Review and contribute to Safety Review Committees, Data Monitoring Committees, and other safety governance forums.
• Interpret emerging safety data and communicate safety implications to development teams and senior governance committees.
• Validate safety signals and lead safety signal assessments.
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms).
• Prepare/review core and regional risk management plans and safety sections of periodic reports.

Skills

MD/DO

Residency completed

Drug safety leadership

Clinical development experience

Education

MD/DO degree

Medical residency completed

Job description

Amgen is seeking a Global Safety Officer, Medical Director for Rare Disease to drive safety strategy across early and late-stage assets. You will lead pharmacovigilance activities, govern safety decisions, and collaborate with cross-functional teams to support global development programs and post-marketing commitments.

You will oversee safety teams, provide strategic input on protocol design, safety monitoring, and regulatory interactions, while ensuring the highest standards of safety for