Clinical Development Director
ClinicalDevelopmentDirectorRenal
“Clinical Development Director - Renal at Clinical Development Director. Skills: Clinical Development, Clinical Trials, Drug Development, Regulatory Affairs, Data Analysis, People Management. Supports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Contributes and if assigned leads development and delivery of clinical sections of trial and program level regulatory documents”
What You'll Achieve.
Delivery of all assigned clinical deliverables in the assigned section of a clinical program; Development and delivery of clinical sections of trial and program level regulatory documents; Execution of the section of the clinical program; Ongoing clinical and scientific review of clinical trial data; Proper data quality and analysis of clinical trial results; Assessing overall risk-benefit of the molecule for the assigned section of the clinical program; Overall program safety reporting; Providing clinical/scientific input into IDP/CDP and CTP reviews; Contributing/driving development of disease clinical standards for new disease areas
Industry & Context.
Ability to analyze and interpret scientific literature and data
What They're Looking For.
Must Have
Advanced degree in life sciences/healthcare (or clinically relevant degree), ≥ 7 years of involvement in clinical research, global drug development in an academic or industry environment spanning clinical activities in Phases through IV, ≥ 5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry, Solid scientific writing skills, Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data, affinity with data, data quality and analysis, Demonstrated ability to establish scientific partnership with key internal and external stakeholders, ≥ 3 years people management experience
Nice to Have
PharmD, or PhD strongly preferred, Experience in late phase clinical development strongly preferred, Experience with regulatory submissions (IND, NDALA, CTA/MAA) preferred, Preferred knowledge and/or experience of assigned therapeutic area
What You'll Do.
Supports and if assigned leads delivery of all assigned clinical deliverables in the assigned section of a clinical program
Contributes and if assigned leads development and delivery of clinical sections of trial and program level regulatory documents
Drives execution of the section of the clinical program in partnership with global line functions
Ensures ongoing clinical and scientific review of clinical trial data
Work in close collaboration with the data management and statistics teams
Supports GPCH in assessing overall risk-benefit of the molecule for the assigned section of the clinical program
Supports overall program safety reporting
Represents the section when assigned in Global Program Team (GPT) meetings
Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews
contributing/driving development of disease clinical standards for new disease areas
How You'll Work.
Team & Collaboration
Drives execution of the section of the clinical program in partnership with global line functions, in particular clinical operations, trial leaders and data management/analysis, and regional/country clinical development associates; Work in close collaboration with the data management and statistics teams; May be the Program or Function Manager of associates (e.g., CDD or associate CDD); Member and if assigned may (co-)lead the Global Clinical Team (GCT); Represents the section when assigned in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetingsoards, as assigned; Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews
Communication Scope
Scientific writing skills; Spokesperson in internal and external meetings
Process & Methodology
Clinical Development Strategy, Clinical Development Plans, Clinical Trial Programs
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