Clinical Development Medical Lead en Michael Page

Contribute and provide methodological expertise on study design as well as medical and scientific input based on his/her medical knowledge when required. Endorse IMP (Investigational medical product) project in front of upper management and contribute providing adequate medical and scientific relationships with investigators, coordinate scientific committees and ensure clinical integrity of the trial subject.

Client Details

International Pharmaceutical Company

Description

• Manage and maintain high performing clinical development teams


• Assure regulatory compliance with FDA regulations, ICH guidelines and SOPs


• Participate in the evaluation of potential new opportunities candidates to enter in a clinical development phase


• Defines, gives support, and endorse the strategy, rationale, objective and design of global clinical development programs and studies.


• Provide medical and scientific expertise to the study team during key activities related to clinical development/clinical trial design and execution plans.


• Coordinate, review and approve the key documents such as investigator brochure, protocol, informed consent, monitoring plan and clinical study report. If needed, be involved also as author.


• Coordinate with Clinical Operations, Biostatistics, Data management, Drug Safety, Legal, Finance and Regulatory to ensure operational excellence


• Provide oversight for Phase 1, 2, 3 global clinical trials


• 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


• Participate in the planning and conduct of Investigator meetings


• When required, act as supervisor for some Medical Monitor teams


• 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


• Maintains professional knowledge through review of medical and scientific literature, affiliating with professional organizations and by participating in continuing education programs and conferences.


• Develops goals for the Clinical Department, including conduct of the clinical development plans to budget and timelines


• Interacts with key opinion leaders


• Plans and leads Advisory meetings

Profile

• Medical degree with at least five years' experience in a Medical Monitoring role/ Clinical development Advisor (preferably Clinical pharmacologist)


• Experience in scientific and medical writing activities, including development of Clinical development Plans, protocols, and Clinical study reports


• High English level (at least Advanced / C1)


• Understanding of local and global drug safety regulations and processes (EU & US)


• Experience providing input into key regulatory documentation.


• Management of global clinical trials and NDA submissions


• Excellent interpersonal skills with ability to relate to both internal and external stakeholders.


• Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.


• Strategical thinking


• Ability to work in cross functional teams

Job Offer

• Social benefits


• Home Office Flexibility


• Career development


• Barcelona offices