Rare Disease Clinical Research Physician

🕒 August 12

🇮🇹 Italy – Remote

💵 €68.5k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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Chiesi Group

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.

📋 Description

• Accountable for the budget, strategy and execution of CMC development and IMP supply from candidate nomination/selection to handover to manufacturing organisation for commercial launch • Build the overall strategic development plan in collaboration with product CT • Develop the CMC strategy, including IMP supply, to meet project milestones and long-term business objectives • Drive execution of the CMC development plan in compliance with the regulatory strategy • Coordinate documentation packages fit for the development phase • Lead new business development opportunity evaluations with focus on CMC • Act as GRD CMC representative in the project core team • Build and organize the ETT by sourcing internal and external competences according to project needs • Lead and manage external consultants and ETT workstreams • Manage CMC project budget, including CROs, CDMOs and consultancy agreements • Act as subject matter expert and workstream lead as required • Review ETT workstream development plans and align them with the overall strategic development plan • Provide technical support in scouting, auditing and selecting CROs/CDMOs • Lead and manage long-term relationships with academic partners, CROs and CDMOs • Provide technical review and approval of relevant documentation for clinical trial and market approval applications • Contribute to department development in line with GRD and R&D strategic goals • Disseminate technical knowledge and leadership skills across the department and adjacent functions

🎯 Requirements

• Minimum Master of Science in relevant field • Minimum 10 years of relevant industrial experience from the pharmaceutical industry • Experience from development or manufacturing of drug substances, drug products or medical devices • Highly experienced in leading and managing internal and external activities, resources, and stakeholders • Experience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements • Experience from working with CMOs and CROs • Good knowledge regarding GMP compliance • Good knowledge of drug development framework including regulatory guidelines, best practices and industry standards • Strong leadership and problem-solving skills • Good skills in written and verbal communication • Project leader skills • English - Fluent in verbal and written communication • Normal to experienced user of MS Office • Broad general experience in development and manufacturing of pharmaceuticals, including analytical development and testing (CGT, biologics and/or small molecules)

🏖️ Benefits

• Annual bonus scheme, subject to company and individual performance • Pension • Private medical insurance • Wellbeing programme • Flexible benefits programme • Comprehensive healthcare programs • Work-life balance initiatives • Robust relocation support • Training and development resources • Flexible working arrangements • Remote work options • Tax assistance services for foreign colleagues