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
Tech Stack
Google Cloud Platform
Benefits
medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs
Employee Assistance Program
travel insurance
retirement savings programs with company matching contributions
vacation, personal days, sick days, and an end-of-year company shutdown
expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees