Ancora offerte alla Novartis

Job ID	127228BR
Posting Title	Sr. Cluster Physician
Division	Vaccines & Diagnostics
Business Unit	Global Development
Country	Italy
Work Location	Siena
Company/Legal Entity	Italy Novartis Vaccines and Diagnostics S.r.l. Siena
Functional Area	Development & Medical
Job Type	Full Time
Employment Type	Regular
Job Description	•Be responsible for strategy and clinical development plans for assigned clinical program, including oClinical strategy of the cluster and its translation into sound Clinical Development Plans (CDPs) oAuthorship/key contributor to clinical documents, including clinical trial protocols, reports and publications and integrated clinical documents for regulatory submissions, safety and strategy •Support the Cluster Head or Clinical Program lead in the administrative and operational requirements of the Cluster and in people management where appropriate •Where applicable, lead matrix team of clinical colleagues (other clinicians, statisticians and clinical research scientists\associates), to author clinical development plans, design clinical trial protocols, clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Accountability to Cluster Head •If applicable and delegated by the Cluster Head, represent clinical development within Global Program team. Provide appropriate support to the GPT to assure GPTs objectives and serve as liaison between the GPT and the cluster/clinical development. •Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents. •Address scientific and medical issues related to one or more projects in the Cluster. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals. •Liaise with PV to develop RMP’s (Risk management plans), Core safety data sheets and serves on SMT (Safety management team), on clinical program level accountable for. In clinical programs, together with PV analyse safety and potential signals and escalate accordingly. •Liaise with the regional physician(s) to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects safety) •Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program •Coordinate the preparation of the Investigator Brochure (and updates) and the Annual Safety Reports to Regulatory Agencies as applicable (eg IND/CTX) •Accountability as principle clinical liaison to Data Monitoring Committee (DMC) •Contribute to the clinical sections of regulatory files, including labelling (SmPC) •Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development and Licensing (BD&L) as applicable •Provide medical support to GPHMA in order to achieve Novartis Vaccine’s objective •Support/replace where applicable the Cluster head in representing of Novartis Vaccines in meetings with health authorities and the scientific community, network with thought leaders and international agencies as needed •Provides operational and administrative management to the Cluster. In this capacity, manage direct reports (objective setting, performance assessment, career development); mentor and train associates in the cluster and other related functions Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology. Novartis is an Equal Opportunity Employer.
Minimum requirements	•MD or DO from accredited institution for Cluster Physician position •Advanced university degree (Masters or PhD) from accredited institution for Clinical Scientific Lead position •Relevant specialty training (i.e. Infectious diseases, pediatrics, immunology, epidemiology) desirable •Board certification desirable •Fluency in written and spoken English with strong ability to interpret and present data •3-7 years industry experience or 10+ years experience working in a scientific or medical institution (i.e. for Sr CSL, prior experience as principal investigator, medical monitor or commensurate to Clinical Research Scientist position at NVD) •Understanding of GCP and ICH guidelines; experience working with Regulatory functions (i.e. filing IND, BLA, CTD) a plus •Demonstrated solid experience working with multi-cultural, multi-located teams •Previous vaccinology experience highly desirable •Ability to travel 25% domestically and internationally