Head of Clinical Development

Our client is a biopharmaceutical company focused on the development and commercialization of proprietary recombinant therapeutic proteins with an initial focus on complex therapeutic proteins for the treatment of rare genetic disorders.

Job Description:

Position Reporting to: Chef Product Development Officer Location: Israel North (minimum 3 times a week)

Reporting to the Head of the Clinical Development: Head of the Clinical Operations, PV expert and the Data management (DM)/BioStat specialist

Duties and Responsibilities:

The Head of the Clinical Development is responsible to:

• Manage the overall activities of the clinical program(s)

• Oversight and support the activities of the Sr Director Clinical Operations

• Oversight and support the activities of the Safety Expert

• Oversight and support the activities of the Clinical Data

• Provide clinical input and review regulatory documents and submissions as requested by regulatory affairs

• Reviews and approve of the Annual Safety Report

• Details responsibilities in Clinical trials:

Proposes, develops and approves study outline, ensuring appropriate medical/clinical disease related guidelines are implemented

Approves and reviews clinical study documents ensuring appropriate clinical and scientific input is available and implemented

Ensures that the Sponsor’s activities in the clinical program are conducted according to the client GCP SOPs

Approves the Clinical Study Protocols and Amendments (as Sponsor Representative) • Approves the “Template” Inform Consents (ICF)

• Approve ICF and CP medical related amendment issues

• Ensures study plans are available prior to first site initiation

• Reviews and updates the trial-specific risk management plan

• Oversight IRB/EC interactions

• Plan and lead investigators’ meetings according to study timelines

• Ensures that study required vendors (including labs) consultants are in place according to study timelines

• Approves the sites selected for participation in the study

• Ensures drug labeling, shipment and drug accountability processes are in place

• Supports clinical operation team in case of major escalated issues

• Approve the Medical monitoring plan and Safety monitoring plan

• Lead communication with Clinical Investigators

• Leads the planning and conduction of Principal Investigators’ (PI) meetings

• Support Medical affairs activities for conducting Medical Advisory Boards

• Ensures SAP is developed and signed off prior to a planned analysis and approve the SAP statistical analysis plan

• Authorizes database lock

• Approves the Clinical Study Report (CSR)

Required Education, Experience and Qualification:

Education:

MD required Profile requirements

• Global experience in required

• Substantial experience in Clinical Trials

• Experience in clinical team management and Matrix management

• Self-starter/independent

• Excellent English

• Excellent communication skills

• Inspiring and supportive team leader

• An assertive, driven and hands-on individual who is self- motivated

#MD #ClinicalTrails #International #Managment

C.V to: [email protected]