Provide senior physician-level medical monitoring support for an active hematology clinical development program, with close review of patient-level and aggregate safety and efficacy data. The work centers on study-team partnership, emerging data trends, protocol questions, and medically relevant issues in a fast-moving biotech setting. The role also contributes to regulatory readiness and program communications across abstracts, presentations, and publications.
Key Responsibilities
- Provide medical monitoring support for an ongoing hematology clinical program.
- Review clinical and safety data and partner with the study team on patient-level and aggregate data interpretation.
- Collaborate with clinical scientists, clinical operations, biostatistics, safety, regulatory, and medical affairs.
- Contribute medical input to regulatory documents, submission-related materials, and health authority response activities.
- Support clinical content for abstracts, presentations, publications, and other program communications.
- Help evaluate emerging data trends, safety signals, protocol questions, and medically relevant study issues.
- Partner with cross-functional team members to support study execution, data-cleanup activities, and regulatory deliverables.
- Help maintain strong medical oversight and execution discipline in a lean biotech environment.
Required
- MD or equivalent physician training.
- Significant hematology experience.
- Experience working as a medical monitor and/or clinical development physician.
- Ability to contribute to clinical data review, safety review, and study-level medical decision-making.
- Ability to support regulatory and submission-related documentation.
Preferred
- Lymphoma expertise.
- Prior experience in biotech or pharma.
- Experience supporting late-stage oncology or hematology clinical programs.
- Background working in a lean, cross-functional team environment.
- Experience contributing to health authority responses and other regulatory interactions.