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Data: 12/07/2013
Novartis Italia ricerca: Cluster Head P&S (Job ID 122216BR).
Job Description
Job Purpose
• Contribute to relevant Global Project team (GPT) strategy (as full or ad hoc member).
• Directly responsible and accountable for creating and updating the cluster relevant Clinical Development Plans (CDPs) in line with GPT strategy.
• Accountable for scientific and operational quality and timeliness of clinical study protocols, reports and publications of the studies included in CDPs and the integrated clinical documents for regulatory submissions.
• Manage, mentor and develop Cluster associates.
Major Accountabilities
• Full or ad hoc membership of a Global Project Team (GPT) providing scientific and medical input to the GPT and development strategy for Cluster's projects.
• Accountability and direct responsibility for the Clinical Development Plans (CDPs) of the Cluster's projects. CDPs must reflect the overall strategy and be regularly updat-ed.
• Accountability for the Cluster's clinical trial documents: clinical study protocols, re-ports and publications, integrated clinical documents for regulatory submissions and other interactions with Health Authorities. Goal: scientific, operational and ethical ex-cellence, delivery on time and high-level oversight of budget.
• Ad hoc participation to Senior Management Boards (IB, DLC, VPRC) as appropriate to discuss\propose clinical strategies, CDPs and\or report on study results.
• Participation and presentation at meetings with wealth authorities and regulatory bodies, as appropriate.
• Support to Regions and Strategic Global Marketing re: presentations, investigators' meetings, as appropriate.
• Clinical lead in "Due Diligences" and other clinical activities in support of Business Development and Licensing (BD&L).
• Membership of extended Clinical Development Cluster Leadership team.
• Management of Cluster associates: performance management, objective setting, career development, mentoring.
• Budget and resource planning for the respective Cluster.
Minimum requirements
Education:
• Typically, MD Degree and relevant specialty/subspecialty training, (i.e., paediatrics, internal medicine, epidemiology, immunology, in- fectious diseases).
• An advanced degree in Health Science (Biology, Pharmacy, Biostatistics, etc.) is also be acceptable, if combined with outstanding tack record in clinical research or regulatory affairs.
• Excellent knowledge of written and spoken English At least 10 years hands-on experience in clinical research, of which at least 6 years industry Leadership skills, adequate for a global function.
• Ability to manage and develop people.
• Problem solving and crisis management skills.
• Ability to connect with a broad range of cultures.
• Excellent communication and presentation skills.
Desirable
• Previous experience in the field of vaccinology.
Division: Vaccines & Diagnostics.
Business Unit: Global Development.
Country: Italy.
Work Location: Siena.
Company/Legal Entity: Novartis Vaccines and Diagnost.
Functional Area: Development & Medical.
Job Type: Full Time.
Employment: Type Regular.
Per ulteriori informazioni potete consultare il seguente link.
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