The position reports to the Head of Internal Medicine, within the Corporate Clinical Department.
The selected physician will contribute to the aims of the Line Function by allocating his/her skills and expertise in the development of clinical strategies, design of clinical trial protocols, writing of studies reports and other regulatory documents. The selected physician will be a member of a number of project teams.
Job responsibilities
• Proposal of the clinical development plans for selected products, to establish their safety and efficacy, and to support registration of such products in the shortest possible time. These plans will form the clinical basis in overall corporate project plans and should include phases I, II, II or IV (as appropriate).
• Scientific support to the clinical studies development, in line with the Lifecycle Management Plan and the relative Clinical Development Plan, expecially those requiring his/her Therapy Area expertise, where he/she is deeply committed to acts as the main reference point.
• Develop and enhance experience in management of clinical studies, working in collaboration with the Clinical Programme Leader and the other involved roles.
• Production of the clinical parts of the Common Technical Document, according to elaborated data coming from scientific documents related to the concerned clinical studies; represent the Company in front of the institutional authorities concerned.
Education
Medical Doctor with broad experience in different therapeutic areas. Speciality in Internal Medicine will considered as preferential.
Required experience
• Significant work experience in clinical or academic research
• Preferred previous experience in pharmaceutical industry
Technical skills
• Good working knowledge of GCP and ICH guidelines
• Experienced in writing protocols/reports
• Computer skills required
Per candidarsi: r.negri@pharmapoint.it
