Associate Director, Clinical Scientist

Associate Director, Clinical Scientist - Clinical Trials (MASH) Key Responsibilities Contribute to design/development of clinical trial protocols: scientific rationale, objectives, endpoints, eligibility criteria. Author/review key clinical and regulatory documents (investigator brochures, informed consent forms, CSRs, regulatory submissions). Provide scientific input during execution (protocol amendments, site engagement, data reviews, ongoing study support). Collaborate with clinical operations, data management, biostatistics, and medical writing to ensure trial quality and data integrity. Conduct data reviews and support data interpretation with biostatistics/medical. Support regulatory submission and health authority meeting document preparation and internal governance presentations. Stay current on MASH/NASH therapeutic trends, competitive landscape, and regulatory guidance. Participate in cross-functional meetings; contribute to strategies and timelines. Experience and Professional Qualifications Advanced degree (PhD/MD/PharmD or equivalent) required; master’s with relevant experience may be considered. 2+ years clinical development or clinical research in pharma/biotech. 10+ years relevant experience. Strong preference: prior liver disease, metabolic disorders, or MASH/NASH experience. Solid knowledge of ICH/GCP and global clinical trial regulations. Ability to synthesize complex scientific data; strong verbal/written communication. Collaborative mindset; strong organizational and project management. Preferred Attributes Experience in fast-paced biotech with small, agile teams. Familiarity with liver disease endpoints (histology, imaging, non-invasive biomarkers). Experience supporting regulatory interactions/submissions. Benefits Full-time employees eligible for comprehensive benefits, including flexible PTO, medical/dental/vision, life/disability, and 401(k) offerings. #J-18808-Ljbffr