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| OFERTES DE FEINA |
17/01/2011 |
| Varis - Farmacòleg clínic |
Empresa ofertante: LABORATORIS SANIFIT SL
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BRIEF
• Job Role: Clinical Trials
• Location: Spain
• Sector: Biotechnology Industry
• Job Hours: Flexible arrangement
About LABORATORIS SANIFIT
Laboratoris Sanifit is a leading company in drug development of products to treat calcium disorders. The company’s lead product, SNF472, is an intravenous calcification modulator to treat cardiovascular disease in dialysis patients. SNF472 is currently finishing the preclinical program and will start first-in-human studies in the last quarter of 2011. The approach of targeting calcification has resulted in a promising pipeline of calcification modulators against major diseases in the cardiovascular, renal and osteoporosis areas.
Tasks & responsibilities:
• Clinical Pharmacology support to project teams.
• Clinical Pharmacology data analysis and interpretation in preparation for study reports and in preparation of documents for IND filings.
• Contribute and lead the company’s clinical strategy, design and implementation, together with internal (project teams) and external (CROs) support.
• Coordination between internal clinical management and external CROs, project teams and physicians and/or their staff ; supporting investigators, and ensure compliance with protocol.
• Management of bioanalytical vendors and review of analytical methods, method validations, project plans, and data reports.
• Clinical pharmacokinetic data analysis, validation and QA; databases and record keeping system; evaluation and analysis of clinical data, report trends and progress of trials .
• Analysis and elaboration of data for reporting internally and external presenting or publication
• Providing ongoing, objective updates on progress and problems with projects, identify issues, and analyze and recommend solutions; tracking and following up on action items
• Oversee alignment of clinical research program with company objectives; taking corrective actions or implementing contingency plans and reporting to company
Qualifications and skills:
• Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or similar
• Knowledge of industry drug/ medical device clinical development and regulatory requirements.
• Proficient in English and ability to communicate with precision in this language is required.
• Leadership skills - effective project team management; motivation and delegation, developing trust and confidence with external and internal stakeholders; timely/quality decision making
• Strong communication skills (verbal and written) and presentation skills required. Excellent interpersonal skills and ability to function in a team environment are essential.
• Travel may occasionally be required.
Experience
• Outstanding track record of experience in pharmacokinetics and modeling, pharmacodynamic principles, ADMEconcepts and bioanalytical principles.
• Experience working in design, organization and execution of clinical trials in a pharma company or CRO; experience in drug development is highly desired
• Proficient in standard MS and pharmacokinetic software.
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