Global Safety Medical Director – Hematology/Oncology
Amgen
Medical Director
ProPharma
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Oversees the management of medical monitoring during clinical trials and projects.
- Acts as liaison for investigators and monitors regarding study-related medical/safety issues.
- Provides and/or oversees medical review of key clinical documents and regulatory documents.
- Provides support and input into the planning, design, preparation, initiation, and execution of study protocols.
- May present topline results to Sponsors or Competent Authorities.
- Trains project team on therapeutic indication and/or treatment modality.
- Oversees, reviews, and directs medical and safety sections of regulatory document submissions.
- Assists with RFI/RFP completion and contributes medical/scientific expertise to proposal development.
- Actively participates in early client engagement calls.
Requirements
- Medical Degree (MD/DO) or international equivalent from an accredited university.
- Completion of an accredited residency program.
- Certification: Preferably board certified in the US.
- Minimum of one (1) year in a CRO environment.
- Minimum of three (3) years of clinical research and medical/safety management experience in the pharmaceutical industry.
- Minimum of five (5) years of clinical, patient-facing experience, post-residency.
- Excellent organizational skills.
- Strong written communication skills.
- Ability to prioritize workload and meet deadlines.
- Flexible and proactive toward changing needs.
- Effective interpersonal communication skills.
Benefits
- We celebrate our differences and strive to create a workplace where each person can be their authentic self.
- We are committed to diversity, equity, and inclusion.
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
- With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical monitoringclinical trialsmedical reviewstudy protocolsregulatory documentsRFI completionRFP completionproposal developmentsafety managementclinical research
Soft skills
organizational skillswritten communicationprioritizationflexibilityproactivityinterpersonal communication
Certifications
Medical Degree (MD/DO)board certification
