Clinical Development Lead

The Clinical Development Lead has the responsibility and authority for:

Preparing clinical development plans & study documents, defining studies which are necessary to efficiently reach the defined goal or objectives in agreement with the project team and in compliance with Ferrer’s QMS, ICH/GCPs , medical devices guidelines, EU&US regulations, local requirements, as applicable; management of all internal clinical activities and oversight of activities contracted to CRO/ other vendors ( key performance & quality metrics), mentoring and delegating study activities to a CPM( Clinical Project Manager). Participates in the multi-disciplinary project team, including drug/ medical device development team, as the main responsible of the clinical development. Identify and propose vendors to specific tasks related to clinical development according to quality standards.

Functions & Responsibilities

• Prepare Clinical Development Plans, according to the nature of the clinical project and its objectives: exploratory research, support a marketing authorization application, marketing and commercialization support , new indication, etc. ensuring that all aspects of ICH-GCP, medical devices guidelines/regulations and agreed quality standards are complied with at all times.
• Participation in the multi-disciplinary project team as the responsible of the project clinical development and presentation of the CT results, aligned with PL when appropriate (teams and committees)
• Planning of each specific clinical project in conjunction with the PL and all study vendors.

• Prepare and/or review and approve essential study documents (Study Protocol and Patient Information sheet, CRF, Clinical Study Report, etc.) and other study related documents (study plans…etc..)
• Management of internal clinical activities and supervise the activities of contract research organizations by reviewing key study performance/ quality and lead risk mitigation activities to ensure the timely delivery of study results and reports that comply with the applicable quality requirements and escalate areas of concern to Clinical Development Head and Quality Assurance Department as appropriate.
• Maintaining CTMS and SOPs (QMS) updated
• Provide support to IB, IND/IMPD, CTD, regulatory processes, annual reports, scientific advice procedures, safety risk management plans, BD managers during due diligence processes, market access related to clinical development.
• Supervise clinical trial related activities delegated/ shared  to/ with CPM.
• Supervise clinical trial related activities delegated to Clinical Trial Assistant (CTA)

Ferrer guarantees equal treatment and opportunities, avoiding any type of prejudice or stereotyping, throughout the entire recruitment and integration process. Only objective criteria such as professional and academic ability and work experience will be assessed.