Responsibilities:- To guarantee the execution of the activities related to clinical development and statistics/data management assigned to the “Clinical Operations”, to the “Statistics/Data Management” and to the “Clinical Services” unit, respectively, ensuring managerial, technical and scientific support to their heads.- To guarantee the execution of the activities related to clinical Quality Assurance (sites and third parties audits, pre-inspections activities)- To have the… Show more Responsibilities:- To guarantee the execution of the activities related to clinical development and statistics/data management assigned to the “Clinical Operations”, to the “Statistics/Data Management” and to the “Clinical Services” unit, respectively, ensuring managerial, technical and scientific support to their heads.- To guarantee the execution of the activities related to clinical Quality Assurance (sites and third parties audits, pre-inspections activities)- To have the “Clinical Operations”, the “Statistics/Data Management” and the “Clinical Services” unit work in an efficacious way, making the respective workloads balanced and favoring their interactions.- To take part, if requested, in late stage assessments and/or due diligence on new compounds.Therapeutic Area and Indications:Cancer Supportive Care: Chemotherapy Induced Nausea and Vomiting (both Adult and Pediatric Trials), Chemotherapy Induced Diarrhea.Cancer Care: Hematology (AML, MDS)Pain: observational studies. Show less

Responsibilities:- To guarantee and coordinate the activities regarding the clinical development assigned to the Clinical Development Unit 2, providing scientific and technical support to the reporting Clinical Operations Managers (2 people), contributing to defining, planning, coordinating and controlling the activities leading to the completion of:o the clinical trials described in the development plan of the compounds under investigationo the clinical trials that could impact on… Show more Responsibilities:- To guarantee and coordinate the activities regarding the clinical development assigned to the Clinical Development Unit 2, providing scientific and technical support to the reporting Clinical Operations Managers (2 people), contributing to defining, planning, coordinating and controlling the activities leading to the completion of:o the clinical trials described in the development plan of the compounds under investigationo the clinical trials that could impact on the already approved labels- To collaborate to risk assessment and risk analysis and to guarantee the implementation of the activities linked to it- To support the Head of Corporate Clinical Development in the assessments of new compounds under the company’s evaluation- To line-manage the co-workers Therapeutic Area and Indications:Cancer Supportive Care: Chemotherapy Induced Nausea and VomitingUrology: Overactive Bladder Show less

Responsibilities:- To represent the Corporate Clinical Development within the company team dedicated to the development of a chemotherapy agent in the indication “biliary cancer not amenable to surgery”- To evaluate the activities and the clinical trials conducted by the company from which the chemotherapy agent was licensed- To define and plan for new clinical trials through to registration - To coordinate and implement the clinical trials mentioned above within time and budget… Show more Responsibilities:- To represent the Corporate Clinical Development within the company team dedicated to the development of a chemotherapy agent in the indication “biliary cancer not amenable to surgery”- To evaluate the activities and the clinical trials conducted by the company from which the chemotherapy agent was licensed- To define and plan for new clinical trials through to registration - To coordinate and implement the clinical trials mentioned above within time and budget as per development plan- To prepare and attend meetings with regulatory bodies (FDA, EMEA)- To supervise the CRO’s management of the phase III trialTherapeutic Area and Indications:-Oncology: biliary tumors Show less

Responsibilities:- To participate in drafting, reviewing and finalizing the Clinical Development Plan of new compounds;- To support harmonization of various phases of product development, clinical projects (phases I-III) and pre-clinical studies, in order to guarantee an appropriate and ready management of any related issues;- To provide supervision to designing of clinical trials and to propose changes to CDP where opportune;- To monitor the progress of activities foreseen by… Show more Responsibilities:- To participate in drafting, reviewing and finalizing the Clinical Development Plan of new compounds;- To support harmonization of various phases of product development, clinical projects (phases I-III) and pre-clinical studies, in order to guarantee an appropriate and ready management of any related issues;- To provide supervision to designing of clinical trials and to propose changes to CDP where opportune;- To monitor the progress of activities foreseen by CDP;- To hold contacts with Investigators and Opinion Leaders in the indicated Therapeutic Area;- To manage the “Product Teams” composed by experts of the different functions involved in pre-clinical and clinical development;- To interact with CROs, both regarding the assessment of new proposals and the daily management of ongoing trials.Therapeutic Area and IndicationsCNS: - Parkinson’s Disease; Epilepsy; Neuropathic Pain Show less

Responsibilities- To provide strategic and financial overview to international clinical trials;- To coordinate and lead a team of Clinical Project Managers; - To define training and career path for direct and indirect co-workers- To give technical support to International Business Development;- To identify new business opportunities;- To manage company special projects.Main Therapeutic Areas and Indications- Oncology: Metastatic Melanoma.- Rheumatology:… Show more Responsibilities- To provide strategic and financial overview to international clinical trials;- To coordinate and lead a team of Clinical Project Managers; - To define training and career path for direct and indirect co-workers- To give technical support to International Business Development;- To identify new business opportunities;- To manage company special projects.Main Therapeutic Areas and Indications- Oncology: Metastatic Melanoma.- Rheumatology: Rheumatoid Arthritis.- CNS: Mild Cognitive Impairment. Show less

Responsibilities:- To act as the first reference to the Sponsor for the outsourced trial;- To create and update the “project plan”;- To assign tasks and responsibilities to the project team members;- To overview the study progress;- To identify and implement corrective actions;- To manage study finance; - To select investigational sites;- To provide line management to the assigned CRAs;- To give technical support to International Business Development- To… Show more Responsibilities:- To act as the first reference to the Sponsor for the outsourced trial;- To create and update the “project plan”;- To assign tasks and responsibilities to the project team members;- To overview the study progress;- To identify and implement corrective actions;- To manage study finance; - To select investigational sites;- To provide line management to the assigned CRAs;- To give technical support to International Business Development- To select CRAs in Italy and in EuropeTherapeutic Area and IndicationsCNS: “Mild Cognitive Impairment; Painful Peripheral Neuropathy. Show less

Responsibilities- To manage and coordinate a team of home-based CRAs (~ 20 units) - To act as the “trial leader” for international clinical researches; - To plan and control administrative and finance aspects of the projects assigned.Therapeutic Areas and Main Indications: - Oncology: Acute Myeloid Leukaemia, Prostate Cancer, Multiple Myeloma, Breast Cancer, Pancreatic Cancer. - CNS: Alzheimer’s Disease, Head Trauma, Bipolar Disorders. - Immunology: Autoimmune… Show more Responsibilities- To manage and coordinate a team of home-based CRAs (~ 20 units) - To act as the “trial leader” for international clinical researches; - To plan and control administrative and finance aspects of the projects assigned.Therapeutic Areas and Main Indications: - Oncology: Acute Myeloid Leukaemia, Prostate Cancer, Multiple Myeloma, Breast Cancer, Pancreatic Cancer. - CNS: Alzheimer’s Disease, Head Trauma, Bipolar Disorders. - Immunology: Autoimmune Diseases, Organ Transplantations, IBS.- Dermatology: Systemic Aspergillosis. - Metabolism: Osteoporosis, Diabetes Mellitus.- CVS: Hypercholesterolemia, Congestive Heart Failure.Results- Registration of Rivastigmine in “Alzheimer’s Disease” Show less

Responsibilities- To monitor national and international clinical trials;- To manage and coordinate a team of Italy home-based CRAs and supporting staff; - To act as the “trait d’union” between CRAs and Therapeutic Areas within Medical Direction;- To train and update CRAs;- To coordinate CRO’s activities on specific projects;- To act as the local “GCP officer”;- To perform pre-auditing activities at Italy investigational sites.Therapeutic Areas and Main… Show more Responsibilities- To monitor national and international clinical trials;- To manage and coordinate a team of Italy home-based CRAs and supporting staff; - To act as the “trait d’union” between CRAs and Therapeutic Areas within Medical Direction;- To train and update CRAs;- To coordinate CRO’s activities on specific projects;- To act as the local “GCP officer”;- To perform pre-auditing activities at Italy investigational sites.Therapeutic Areas and Main Indications- Oncology: Breast Cancer, Pancreatic cancer- CNS: Alzheimer’s disease, Ischemic Stroke - Immunology: Autoimmune Diseases- Hematology: Hodgkin and non-Hodgkin lymphomas; Myelodisplastic Syndromes- Metabolism: Osteoporosis- CVS: Hypercholesterolemia, Anti-aggregating TherapyResults- Creation and consolidation of the Monitoring Unit within Medical Direction Show less

Responsibilities- To monitor national and international clinical trials according to GCP rulesTherapeutic Area and Main Indications: - Dermatolgogy: Psoriasis, Alopecia - Immunology: Rheumatoid Arthritis, Nephrotic SyndromeResults- Introduction of GCP rules to clinical trials in Italy- Registration of Cyclosporine in “Severe Psoriasis”