We are currently partnering with an exciting specialist Biotech, focused in Hematology and Oncology, Solid tumors who are seeking a Vice President of Clinical Development.
The company is a small specialist Biotech, specifically focused on improving survival for individuals who have failed existing Oncology Therapies.
This is a chance to help in a real unmet need, and the have had very positive readouts recently
This position will work very closely with the CMO and you will likely lead multiple hematology / solid tumor programs within the organization, hopefully through to submissions
Key responsibilities:
- Supervise the writing and execution of clinical protocols and all supporting documents, including Informed Consent Forms (ICFs); Investigator Brochures (IBs); Imaging, Nursing, and Pharmacy Manuals; Data Monitoring Committee (DMC) and Endpoint Adjudication Committee (EAC) Charters; and all CRO-specific plans, and maintain these documents as needed due to protocol amendments
- Work with Regulatory Affairs in drafting clinical sections of pre-FDA meeting packages and participate in FDA, or other health authority, meetings as needed
- Oversee clinical trial site selection, CRF design, and other clinical trial activities
- As Program Director for one or more clinical development programs, lead clinical development strategy in hematology as well as the execution of the clinical development plans
- Responsible for the planning and execution of clinical studies in order to successfully move programs though the clinical research process in a timely manner, in adherence with Good Clinical Practice, appropriate Standard Operating Procedures and government regulations
Qualifications:
- MD
- Minimum of 5 years oncology experience strongly prefer clinical research experience be mostly in the field of hematology
- Minimum of 8-10+ years of experience in clinical research required
- Training in GCP and knowledge of the research process, of the importance of adherence to protocols, and of the accuracy needed in collection and documentation of research data
- Must have the ability to obtain and interpret clinical data as it relates to the diagnosis and treatment of research subjects in company clinical trials
If interested, please apply or send your CV to ...@barringtonjames.com