What are the responsibilities and job description for the Vice President, Clinical Development, ADC oncology position at RBW Consulting?
A fast growing biotech business with an unrivalled pipeline in solid tumor and malignant hematological assets is looking for a Vice President of Clinical Development - ADC Oncology.
This is a remote role with a team of professionals working across the US.
The Vice President, Hematology will lead Clinical and Medical Hematology assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners.
As a senior leader in the organization, you will design clinical program strategy assuring that activities are executed by your team within expected scope, budget and timelines. The incumbent will lead the growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will develop colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance, regulatory, molecular diagnostics, and translational research.
Essential Functions of the job :
- Facilitate generation of, author, update, and / or review key documents, including, but not limited to : Clinical study reports, abstracts, posters and manuscripts, clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), annual reports, and developmental safety update reports, clinical sections of Health Authority Briefing Documents, Orphan Drug applications
- Risks / benefits analysis for applicable documents
- Clinical Development Plans
- Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
- Provide scientific expertise for selection of investigator and vendors
- Train colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and / or clinical protocol
- Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs / IECs, Health Authorities, and CROs
- Review, query, and analyze clinical trial data
- Informed consent documents
- Investigator Brochures
- Interpret, and present clinical trial data both internally and externally
- Represent a clinical study or development program on one or more teams or sub teams
- Create clinical study or program-related slide decks for internal and external use
- Build and maintain opinion leader / investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
- Contribute to or perform therapeutic area / indication research and competitor analysis
As a senior executive you will be very well compensated with an excellent salary, bonus and a lucrative stock program. For more information on the role and the company please CLICK APPLY and forward your up to date resume.
