Clinical Development Lead

Job Description

Alvotech is looking to hire a Clinical Development Lead who will play a pivotal role in the strategic planning and preparation of Clinical Development Plans (CDP) for assigned clinical programs. As a clinical expert, this role supports Clinical and Medical Affairs Group in interactions with external stakeholders such as regulatory authorities, key opinion leaders, data monitoring boards, and advisory boards, as well as internal stakeholders including CMA, GRA, and Device Development. The Clinical Development Lead is responsible for ensuring state-of-the-art scientific input into all relevant clinical and regulatory documents for assigned projects. Additionally, this role involves thorough review, interpretation, and presentation of clinical trial data for further discussions, both internally and externally, in collaboration with Medical Leads. Scope & Responsibilities: Lead preparation and review of clinical documents (protocol synopses, protocols, clinical trial reports, IMPD sections, IB). Ensure scientific excellence in clinical development strategy, trial designs, and regulatory documents. Lead the preparation of Clinical Development Plans (CDP). Provide high-level scientific input for safety reports, briefing documents, INDs, NDAs, and other regulatory submissions. Offer clinical/scientific input during clinical trial development and execution, including data review activities. Contribute to study documents (e.g. SAP, DMP). Interpret clinical trial data. Lead interactions with regulatory authorities for clinical development discussions. Participate in or provide input for independent monitoring committee meetings. Maintain up-to-date training records. Stay current with ICH-GCP requirements. Job Requirements: Education : Minimum Master s degree in life sciences or equivalent. M.D., Pharm.D., Ph.D. strongly desired. Experience : 5+ years in relevant roles within the Pharmaceutical Industry. Scientific Background : Strong background in pharmacology, immunology and/or oncology preferred. Biosimilars/Biologicals Experience : Prior experience with biosimilars or biologicals essential. Language Skills: Fluent in English (written and verbal). Additional languages are a plus. Leadership and Interpersonal Skills : Strong leadership, participation, and team contribution skills, with the ability to build team spirit, communicate openly, and share knowledge. GCP Knowledge : Deep understanding of GCP and GxP. Technical Skills : Proficient with Microsoft Office (Word, Visio, Excel, PowerPoint). What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.