Senior Medical Director, Clinical Development

Medical Director / Senior Medical Director - B-Cell Malignancies

RBW is partnered with a mid-sized biotech, and they are looking to expand their hematologic malignancy clinical development team. The company recently received best in class data for their B-Cell malignancy programs and they are looking to expand their team.

Job Summary

Our client is looking to hire an experienced Medical Director / Senior Medical Director, Clinical Development to oversee multiple late phase hematologic malignancy programs. This role will report directly to the VP and will be responsible for the development of clinical research strategies and direction.

Job Responsibilities

• Contribute to the development of protocol concepts, synopses, protocols, and amendments.
• Craft informed consent documents that adhere to regulatory requirements and ensure patient understanding.
• Collaborate in the preparation of Investigator Brochures.
• Compile and analyze clinical study reports, extracting meaningful insights from trial data.
• Compose abstracts, posters, and manuscripts for presentation at scientific conferences and publication in peer-reviewed journals.
• Draft clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports.
• Formulate clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports.
• Oversee the development and implementation of Clinical Development Plans.
• Offer continuous scientific and medical support throughout the clinical trial process, promptly addressing clinical inquiries from sites, IRBs/IECs, Health Authorities, and CROs.
• Interpret and present clinical trial data effectively, both internally and externally, fostering clear communication and dissemination of findings.

Qualifications

• MD with advanced training in Hematology-Oncology
• 3+ years of clinical development experience within the pharmaceutical industry, focused on oncology.
• CLL and late phase experience is a plus