Position Summary
The Associate Director, Clinical Scientist supports the development, evaluation, planning, and conduct of clinical studies for the Neurology Therapeutic Area. Ensures scientific integrity and accurate interpretation of study data; serves as a key scientific/clinical partner across global programs, contributing to authoring clinical documents, supporting trial conduct, and working on cross-functional study teams. Partners with Medical Directors on medical monitoring and with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Medical Affairs, and Regulatory Affairs to translate clinical strategy into operational deliverables and ensure ongoing review of trial data for quality, safety, and protocol compliance.
Key Responsibilities
- Contribute to the scientific development and execution of global Neurology clinical studies per the clinical development plan.
- Develop/review clinical content for study documents: protocols, amendments, ICFs, investigator brochures (IBs), and CSRs.
- Rigorously review and interpret emerging clinical trial data (subject-level and aggregate safety/efficacy) for quality, completeness, consistency, and protocol compliance.
- Participate in cross-functional study teams to ensure timely, high-quality execution of milestones.
- Support study execution activities as a key clinical science resource/SME.
- Contribute to preparation, authoring, and revision of regulatory submissions and health authority responses.
Qualifications
- Advanced scientific or clinical degree (e.g., PhD, PharmD, or equivalent).
- 3β5 years relevant clinical research experience in biopharma/biotech; prior neurology trial experience preferred.
- Experience in clinical trial conduct, including hands-on data review, safety monitoring, and data cleaning.
- Knowledge of clinical development processes, regulatory requirements, and global guidelines (FDA, EMA/EU, ICH, GCP) and SOPs.
- Excellent communication and technical writing; drafting/reviewing/editing clinical-science documents and protocols.
- Ability to work in fast-paced, cross-functional teams; strong organizational skills.
- Travel 10β15%.
Benefits
- Competitive compensation and benefits package; base salary range: $161,700 to $202,200.