Marielle Cohard-Radice Email & Phone Number

• An achievement oriented MD specialized in Gastroenterology and Hepatology with 20 years of pharmaceutical industry experience in clinical development, clinical operations, medical affairs, business development and drug safety.• Contribute to overall business strategy and direction through membership of Therapeutic Area Leadership/Operational and Strategic committees (development and in-licensing) • Design and execution of global clinical programs for biologics and drugs leading to successful regulatory approval and commercialization. • Track record of active participation to successful regulatory submissions ( e.g. IND, NDA, BLA)• Experience with FDA, MHRA and EMA GCP and pharmacovigilance inspections.• Provide scientific/medical leadership in the evaluation of in-licensing opportunities.• Cross-functional multidisciplinary team leadership in both large and small global pharmaceutical companies. • Build and manage small and large groups in a changing global health care environment.Specialties: Therapeutic Areas: Gastroenterology | GI Oncology | Hepatology/Liver Diseases | Infectious Diseases | Dermatology | Urology | Immunology | InflammationPhase I - 4 | Product Life Cycle | Post Marketing CommitmentsClinical Development | Product Strategies | Clinical Development OperationsMedical Affairs | PublicationsDrug Safety | Pharmacovigilance | Risk Management Plans | REMSBusiness Development | In-Licensing evaluation | Due DiligenceCross Functional Leadership | People Management

Listed skills include Clinical Development and Process Improvement.