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 amendmentsInformed consent documentsInvestigator BrochuresClinical study reportsAbstracts, posters and manuscriptsClinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update ReportsClinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reportsRisks / benefits analysis for applicable documentsClinical Development PlansPartner with clinical operations and other functional areas for the successful implementation and execution of clinical studiesProvide scientific expertise for selection of investigator and vendorsProvide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs / IECs, Health Authorities, and CRO'sReview, query, and analyze clinical trial dataInterpret, and present clinical trial data both internally and externallyRepresent a clinical study or development program on one or more teams or sub teamsCreate clinical study or program-related slide decks for internal and external useBuild and maintain opinion leader / investigator networks; organize and present at key opinion leader advisory boards and investigator meetingsQualifications : Required Education : Advanced degree (MD or MD equivalent) is essential with subspecialty training in hematology / oncology (preferred)Experience : 8 plus years of experience within other biotech / pharmaceutical or relevant academic credentialsPrevious participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist roleClinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncologyExpert understanding of global clinical study design and drug development process from discovery to registration and post-marketingThe 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.Please CLICK APPLY and forward your resume.
