Position Overview

Location: Belgium

This leading-edge biotechnology company is developing medicinal products in the area of oncology. The require an experienced Medic to provide medical leadership across the company.

The candidate will be a member of the management board and will report to the CEO. They will take a hands-on approach to leading the clinical development of the company's products in oncology as well as future products. The Medical Director will be responsible for developing the Medical group, and for managing all the activities. These activities include the planning of clinical trials in all phases and delivery of trials through managing third-party contractors. He/She will develop and manage relationships with outside clinical investigators, key opinion leaders and medical advisory boards. They will have primary responsibility for maintaining clinical liaison with regulatory agencies and for fulfilling the company's responsibilities under GCP and for PV.

Responsibilities:

• Plan and direct the company's medical policies and programmes
• Develop the strategic and operational plans for all activities within the Medical Department Lead medical discussions internally and externally
• Contribute to the development of the product/s through participation in a collaborative and cross-functional team environment
• Design medical strategies for life-cycle mgt plans for the portfolio of products Maintain clinical liaison with regulatory agencies
• Develop strategic clinical relationships with physicians including Key opinion leaders
• Act as medical lead medical team member with committees of principal investigators, medical advisory boards and other key committees of clinical experts
• Collaborate in and where appropriate lead the writing of research publications appropriate to support clinical service offerings Liaise with counterparts in partner organisations for co-development
• Oversee clinical content in marketing materials Participate in discussions and negotiations with CROs and clinical service companies.
• Lead a cross-functional team
• Serve as the lead Medical Monitor

Profile:

• Medical Doctor
• Considerable experience in the biotech or pharma industry
• Experience of and knowledge about biotech products and their clinical development
• Knowledge of the therapeutic field of oncology
• Managerial experience Experience of interaction with EMEA, FDA or a national competent authority.