Clinical Development Consultant

2 settimane fa


Rome, Italia Barrington James A tempo pieno
Clinical Development Consultant (Interim)

Medical, PV, Scientific and Clinical Operations - Recruitment Consultant at Barrington James

My client is seeking a Clinical Development Medic with a focus on Phase 1 studies and expertise in Respiratory medicine, particularly within Cystic Fibrosis (CF), Chronic Obstructive Pulmonary Disease (COPD), and Idiopathic Pulmonary Fibrosis (IPF). This position offers an exciting opportunity to contribute to the development of innovative therapies in these challenging respiratory conditions, from early-stage clinical trials through to IND submissions. Lead the design and execution of Phase 1 clinical trials in Respiratory indications, including Cystic Fibrosis, COPD, and IPF, ensuring compliance with regulatory standards and ethical guidelines. Collaborate closely with cross-functional teams to develop and implement clinical development plans tailored to the specific needs of patients with these conditions. Provide medical expertise and guidance throughout the lifecycle of clinical studies, including protocol development, safety monitoring, and data analysis. Prepare and review clinical trial documents, including protocols, investigator brochures, and IND submissions, with a focus on the unique characteristics and challenges of CF, COPD, and IPF. Monitor and interpret emerging scientific and clinical data in these disease areas to inform clinical development strategies and optimize patient outcomes. Act as a medical representative for internal and external stakeholders, including regulatory agencies, investigators, and key opinion leaders, advocating for the advancement of therapies for patients with CF, COPD, and IPF. Qualifications: Medical degree (MD or equivalent) with board certification in a relevant specialty (e.g., Pulmonology, Respiratory Medicine). Substantial experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on Phase 1 studies and expertise in CF, COPD, and/or IPF. Strong knowledge of the pathophysiology, clinical manifestations, and treatment landscape of CF, COPD, and IPF, with a proven track record of contributing to the development of therapies in these areas. Experience in preparing and supporting successful IND submissions and regulatory interactions, particularly for therapies targeting CF, COPD, and IPF. Excellent communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional team environment and engage with key stakeholders in the respiratory community. Demonstrated ability to think strategically and creatively, with a focus on problem-solving and innovation to address the unmet medical needs of patients with CF, COPD, and IPF. Please note that this is a Freelance / interim position which has been estimated to be around 3 days per week on a 12 month contract. If you are passionate about advancing Respiratory medicine, particularly in Cystic Fibrosis, COPD, and Idiopathic Pulmonary Fibrosis, and thrive in a dynamic, collaborative environment, I invite you to apply for this position. Please submit your CV outlining your relevant experience and interest in the role.

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