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 clinical research experience in biotech, pharma, or academic clinical trial leadership.
- Strong experience in oncology drug development, including clinical trial design, execution, and interpretation of safety/efficacy data.
- Solid understanding of Good Clinical Practice (GCP) and regulatory expectations for oncology clinical development.
- Ability to make independent, timely, and high-quality decisions in a fast-paced biotech environment.
- Excellent communication and interpersonal skills with experience collaborating across multidisciplinary teams.
- Strong scientific rigor, analytical thinking, and ability to translate data into clinical insight.
Responsibilities
- Serve as medical monitor for assigned clinical trials, providing ongoing oversight of patient safety, study conduct, and clinical integrity.
- Contribute to clinical study design, operational feasibility assessments, and site selection in partnership with cross-functional study teams.
- Review and provide expert input on key clinical documents, including protocols, informed consent forms, safety plans, and monitoring charters.
- Collaborate with Regulatory Affairs on investigator brochures, briefing documents, and other regulatory submissions and communications.
- Lead and support investigator meetings, site initiation visits, and ongoing relationships with clinical trial investigators.
- Partner with clinical, data management, biostatistics, pharmacovigilance, and external partners to ensure high-quality study execution.
- Oversee interpretation of clinical safety and efficacy data, contributing to study conclusions and development strategy.
- Support scientific communication efforts, including abstracts, publications, presentations, and conference participation.
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