Clinical Physician for Clinical Development
5 giorni fa
Gi Group is one of the world’s leading companies that provide the best services for the development of the labour market. On behalf of biopharmaceutical company, we are looking for a
Clinical Physician for CLINICAL DEVELOPMENT
**Main Responsibilities**:
To guarantee the design of preclinical development plans with refer to own therapeutic area (clinical immunology / Type 1 diabetes), in order to verify the specific medical and clinical sustainability;
To support activities related to business development, including evaluation about new business opportunity, to expand the existing activities in order to developing actual business
To select the CRO’s within the Clin Ops team; to guarantee that CRO’s medical activities are in compliance with study protocols and with the related reference regulations, with established timeline and within the budgets planned.
To plan the operative phases of the implementation, execution and clinical studies (e.g. clinical support to proof of concept and phase I studies, mainly involved in phase II, III). The planning studies have to be in line with allocated budget;
To guarantee and manages stable national and international / global network with Health Care Professionals (HCP) and Life Science Fields in order to support the company in having the best and solid scientific collaborations;
To actively support the medical writing and editing of clinical study documents: e.g. study synopsis, clinical protocol, clinical study report, case report form and investigator brochure review;
To support the medical writing and editing of clinical study document results including training materials, clinical presentations, scientific papers;
To develop and maintain relationships with HCP and clinical centres;
To be involved in internal/external audits;
To be involved in investigator Meetings and to be involved in clinical review of specific SOP’s
Knowledge, Skills & Experience required
Medical Doctor / Scientific degree; Immunology specialization and/or field experience
Previous experiences of at least 5 years in similar roles (endocrinology/diabetes) in pharmaceutical / life science fields is a preferred requirement.
Knowledge of pharmaceutical regulations, with particular refer to GCP;
Knowledge of the business and confidentiality;
Target and objective oriented skills;
Communication skills.
Headquartered in Milan.
Gi Group S.p.A. è autorizzata ad operare dal Ministero del Lavoro (Aut. Min. 26/11/2004 PROT. 1101 - SG).
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