Position Title: Medical Director III
Location: Remote
Pay Rate: $173-$186/hour
Duration: 6 months
Job Description
- Provide medical oversight for clinical trials supporting clinical development programs and product development plans.
- Review, interpret, and communicate emerging safety and efficacy data throughout clinical studies.
- Independently assess serious adverse events (SAEs) and support safety reporting in accordance with applicable regulations and company procedures.
- Oversee study integrity, enrollment, timelines, and key clinical deliverables in collaboration with Clinical Operations.
- Provide medical guidance and training to investigators, site personnel, and clinical study teams.
- Identify clinical and safety risks, determine appropriate escalation, and support data-driven clinical decisions.
- Collaborate with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Quality functions.
- Ensure clinical trial activities comply with Good Clinical Practice (GCP), pharmacovigilance standards, SOPs, and applicable regulatory requirements.
Education
- M.D., D.O., or equivalent non-U.S. medical degree.
- Specialization in Hematology or relevant therapeutic specialty.
- U.S. residency training strongly preferred; subspecialty fellowship desirable.
Required Skills
- 5+ years of relevant clinical/medical experience.
- Independent medical monitoring experience.
- Clinical trial experience, including study oversight and medical monitoring.
- Acute Leukemia and/or Acute Myeloid Leukemia (AML) clinical trial experience.
- Safety data review, interpretation, and risk assessment.
- Serious Adverse Event (SAE) assessment and reporting.
- Knowledge of clinical trial methodology and regulatory requirements.
- Good Clinical Practice (GCP) and pharmacovigilance principles.
- Ability to work with global clinical sites across multiple time zones.
Preferred Skills
- Medical monitoring experience with immunotherapies and/or Antibody-Drug Conjugates (ADCs).
- Pharmaceutical industry clinical trial experience.
- Academic or hospital-based hematology experience.
- Experience with clinical audits, peer review, and quality improvement activities.
- Experience supporting global clinical development programs.
