What are the responsibilities and job description for the Executive Director - Clinical Development Hematology position at RBW Consulting?
A Executive Director Clinical Development Hematology is required by a California based biotech with a broad range of best-in-class assets progressing in malignant hematology. This is a remote opportunity.
About the Company :
The Executive Director will support Clinical and Medical assets within the Hematology franchise by successful development of early and late phase clinical development strategies and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners.
As a leader in the organization, you will be involved with clinical program strategy and help assure that activities are executed within expected scope, budget, and timelines. The VP will play a key role in the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution.
About the Role :
Essential Functions of the job :
- Protocol concepts, synopses, and amendments
- Informed consent documents
- Investigator Brochures
- 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, and annual reports
- 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
- Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs / IECs, Health Authorities, and CRO's
- Review, query, and analyze clinical trial data
- 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
Qualifications : Required Education :
Advanced degree (MD or MD equivalent) is essential with subspecialty training in hematology / oncology (preferred)
Experience :
The company has experienced significant growth and has a range of assets at late stage with potential blockbuster status. They have a talented clinical team but do require a senior leader to further develop this and to represent the business with KOLs and the market generally. This is a high profile leadership role and as such will be rewarded very well in salary, bonus and benefits.
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