Clinical and Medical Development Lead

The essential role of the Clinical and Medical Development Lead is to contribute and provide methodological expertise on clinical development plans and study design as well as medical and scientific input based on his/her medical knowledge when required. Carrying out functions of Medical Monitoring, Clinical Pharmacovigilance and Medical Writing.

Endorse IMP (Investigational medical product) project in front of upper management and contributes providing adequate medical and scientific relationships with investigators, coordinate scientific committees and ensure clinical integrity of the trial subject

Tasks and Responsabilities

• Provide medical expertise to the study team during key activities related to clinical development/clinical trial design and execution plans.
• Defines, gives support and endorse the rationale, objective and design of global clinical development program and study. 
• Participate in the evaluation of potential new opportunities candidates to enter in a clinical development phase
• Responsible for the Clinical Safety activities including :review/ approve serious adverse events reports. Provide aggregate reports, DSURs; Annual Reports.
• Address safety issues across the programs and  studies.

• Participate in the Safety Monitoring Committee for a specific Clinical trial when required
• Coordinate, review and approve the key documents such as protocol and clinical study report. If needed, be involved also as author.
• Play a key role in the interaction with regulatory authorities.
• Coordinates the communication plans for the programs and study results
• Identify opportunities to create a program and project publication plan when required
• When required, act as supervisor for some Medical Monitor teams

Reporting to:  Clinical Development Director

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.