Clinical Research & Development Associate Principal Scientist

Role: Senior expert leading clinical research and development in inflammatory myopathies, JIA, and Sjogren’s Disease, overseeing full project lifecycle from strategy to regulatory submission. Responsibilities: provide specialist scientific and technical expertise; coordinate multidisciplinary teams across research, development, regulatory, marketing, and manufacturing; design and optimize clinical protocols; manage study recruitment, timelines, budgets, and resources; prepare regulatory documents (e.g., CSRs, CTDs, INDs); ensure GCP and ICH compliance; lead process improvements; oversee risk management; mentor clinical teams; monitor scientific, commercial, and regulatory trends to inform project decisions. Qualifications: Bachelor’s degree in a scientific field; extensive experience in pharmaceutical drug development, particularly in autoimmune indications; strong understanding of clinical trial design, GCP, ICH, and regulatory standards; proven leadership in cross-functional project management; excellent communication and stakeholder engagement skills. Preferred: advanced degrees (MSc, PharmD, PhD); significant industry experience with complex clinical projects and regulatory submissions; expertise in autoimmune disease biology and clinical manifestations. HighValue: autoimmune therapeutic areas, biologics or small molecules, late-stage development, GCP/ICH compliance, cross-functional collaboration, global regulatory interactions. Work setup and travel details are not specified.