Madani Rachid
Global Clinical Pharmacology Manager @Sandoz
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WORK HISTORY
Global Clinical Pharmacology Manager @Sandoz
Develop clinical pharmacology, PK and PD strategy for Biosimilar development programs; contribute to the strategy for immunogenicity assessment• Contribute to elaborating strategies that may complement or substitute for clinical outcomes to streamline Biosimilar clinical programs• Provide expert Clinical Pharmacology counsel to the IPT (International Project Team), ICT (International Clinical Team), and other cross functional teams in the context of root cause analyses for specific issues• Ensure quality of the clinical pharmacology plans, project specifications, study protocols, reports, summaries and publications• Responsible for designing and analyzing the PK and PD components of clinical trials in all phases of development• Provide the PK/PD sections of clinical protocols, clinical study reports, Investigator’s Brochures, Health Authority Briefing Books, IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) applications, CTD (Common Technical Document) summaries, and any other relevant document for Health Authority submissions• Establish efficient collaboration with key partner functions within and outside BCD (Biopharmaceuticals Clinical Development)(notably Biostatistics, Bioanalytics, Preclinical, Clinical Development, Regulatory Affairs, Technical Development and Analytical Characterization)• Ensure representation as needed for all health authority interactions• Develop and support external contacts (investigators, academic and regulatory community, partners in collaborations); maintain a contact with the broader Novartis Clinical Pharmacology networkTrainings: Communicate to connect, Leading in a matrix environment, Inspiring and Motivating Individuals
EDUCATION
Faculty of Pharmacy of La Timone, University of Aix-Marseille (France)
Doctor of Pharmacy (Pharm.D.), Master II degree Pharmacokinetics
Faculty of Pharmacy, University of Limoges
PCEP1 & PCEP2, Pharmacy
Aix-Marseille University
Animal surgery habilitation, Surgery
SKILLS
ABOUT MADANI RACHID
Global Clinical Pharmacology Manager
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