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.

• 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.