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**
- 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.

Education/training:

- BS preferably in a relevant biological or health science discipline.
- Clinical Research training

Previous experience
- At least 5 years of clinical research and clinical development experience required, with CRA experience and at least 2 years of study management experience working with all drug/ medical device development phases, preferred. It will be valuable experience in respiratory or neurological clinical studies.
- CRO or Sponsor Study Management preferred

Abilities and Skills
- Excellent verbal and written communication skills required
- English
- advanced level
- knowledge of pre-clinical, clinical development and regulatory processes.
- highly organized and able to work within international environments with team members located in different locations/countries.
- ability to seek and understand different perspectives, developing alternative solutions and valuing options suggested by other within the team.
- ability to understand and clarify boundaries of responsibility within own role and be able to allocate decision-making authority and task responsibilities to other team members as appropriate.
- able to efficiently manage all tasks required during a study, be able to track multiple items and provide guidance on the prioritization of tasks within a study.

**Specific training**
- GCP certificate
- Clinical Project Management training