Clinical Scientist 3, Clinical Development

Responsibilities Provide scientific leadership and independent contribution to study design, protocol development, endpoint strategy, and clinical development planning for assigned programs. Support the development, implementation, conduct, oversight, and reporting of clinical trials, ensuring scientific quality and alignment with program objectives. Perform comprehensive literature reviews and maintain current knowledge of disease areas, competitive landscape, emerging science, and regulatory developments relevant to assigned products and indications. Participate in the review, monitoring, summarization, and interpretation of safety, efficacy, pharmacokinetic, patient‑reported outcome, and other clinical data to support development decisions and recommendations. Collaborate cross‑functionally with Clinical Operations, Biometrics/Biostatistics, Data Management, Pharmacovigilance, Medical Writing, Regulatory, Translational Development, Medical Affairs, and other partners to support high‑quality study execution and documentation. Draft, review, and contribute to clinical and regulatory documents, including study protocols, synopses, investigator brochures, clinical study reports, health authority submission content, briefing materials, abstracts, posters, and manuscripts. Support or lead scientific interactions with CROs, investigators, site personnel, and external collaborators to ensure consistency, scientific integrity, and effective study execution. Contribute to advisory boards, expert meetings, and other scientific interactions that support program development and evidence generation. Support the development of departmental processes, templates, standard operating procedures, and best practices as needed. Requirements MSc or PhD degree in Life Sciences, Biomedical Sciences, Pharmacology or other professional doctorate in pharmaceutical sciences or a related scientific discipline. At least 5–8 years of post‑doctoral experience and/or relevant industry experience, preferably in neurosciences. Experience in clinical research and clinical development with a strong understanding of study design, study conduct, clinical data review, and interpretation. Experience drafting, reviewing, or supporting clinical and regulatory documentation and working effectively in cross‑functional teams. Working knowledge of GCP, ICH guidelines, and regulatory expectations, including familiarity with FDA and EMA environments. Strong organizational skills, attention to detail, and the ability to work independently while contributing effectively in a team environment. Experience in neuroscience, CNS, psychiatry, neurology, or related therapeutic areas is preferred. Demonstrated ability to analyze complex scientific information, generate sound recommendations, and solve problems in a dynamic development environment. Experience working with investigators, CROs, vendors, and external scientific experts is preferred. #J-18808-Ljbffr Jobtailor