Medical Director/Senior Medical Director, Clinical Development
New
USFull-TimeDirector
Salary300,000 - 390,000 USD per year
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Job Details
- Experience
- 3–5+ years
- Required Skills
- GCP
Requirements
- MD, DO, or equivalent medical degree with board certification or strong clinical background in hematology, oncology, or hematology-oncology.
- 3–5+ years of experience in clinical research within biotech, pharma, or academic clinical trial leadership.
- Experience in oncology drug development, clinical trial design, and interpretation of safety and efficacy data.
- Strong understanding of Good Clinical Practice (GCP), regulatory requirements, and clinical development processes.
- Experience working cross-functionally with regulatory, clinical operations, pharmacovigilance, and scientific teams.
- Strong communication skills with the ability to clearly present clinical data and medical rationale.
- Ability to work independently, prioritize effectively, and make timely clinical decisions in a fast-paced environment.
- Preferred: experience in AML, leukemias, or myeloid malignancies, and familiarity with T-cell engagers, bispecific antibodies, or immune effector therapies.
Responsibilities
- Serve as medical monitor for clinical trials, providing oversight of patient safety, study conduct, and issue resolution.
- Contribute to study design, protocol development, feasibility assessments, and site selection in collaboration with clinical and operational teams.
- Review and provide expert input on clinical study documents, including protocols, informed consent forms, safety plans, and monitoring charters.
- Partner with regulatory affairs to support investigator brochures, briefing documents, and regulatory submissions.
- Lead investigator meetings, support site initiation visits, and maintain relationships with clinical trial investigators.
- Collaborate with data management, biostatistics, pharmacovigilance, and translational teams to analyze and interpret clinical safety and efficacy data.
- Support publication strategy, scientific communications, and presentation of clinical data at internal and external forums.
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