Job Description

Leal Therapeutics is seeking a highly driven Senior Clinical Scientist to join its Clinical team. This role will report to the VP of Clinical Development and support a range of functions including clinical protocol development, regulatory affairs, pharmacovigilance and data review strategy and analysis.

About Leal Therapeutics:

• Clinical-stage biotechnology company developing novel, precision therapeutics for major diseases of the central nervous system (CNS) with critical unmet needs including Schizophrenia and ALS
• Core operations in Worcester, MA and Newton, MA
• Fast-paced startup environment with broad exposure to multiple facets of biotechnology and drug development
• Emphasis on cross-functional collaboration within a collegial, learning-oriented environment
• Ability to have a large impact in a rapidly growing company

Key Responsibilities:

• Clinical Protocol Development: Contribute to the design and development of clinical trial protocols, ensuring they meet high scientific, clinical, and regulatory standards. Collaborate closely with clinical team members to identify the need for, and implement, protocol amendments as necessary.
• Regulatory Documentation and Publications: Prepare and review study-level documents, including clinical sections of Investigator’s Brochures, briefing books, regulatory submissions, safety updates, and other key reports. Contribute to the writing and review of publications and documents for clinical trial activities.
• Pharmacovigilance Support: Contribute to pharmacovigilance activities, such as aggregate safety reports, patient narratives, and attending safety monitoring meetings.
• Regulatory Agency Interaction: Support the clinical team in preparing and participating in regulatory agency meetings, ensuring robust clinical input in all documentation and interactions.
• Data Review Strategy & Study Consistency: Contribute to the development of data review strategies and ensure the consistent implementation of study protocols across sites and countries. Support the creation and refinement of Case Report Forms (CRFs) and data capture tools to ensure high-quality clinical data collection.
• Clinical Data Analysis: Perform ongoing patient-level data review and trend analysis to provide scientific and medical insights throughout the study lifecycle, including supporting interim analyses and resolving issues.
• Continuous Improvement: Advocate for and contribute to the continuous improvement of clinical processes, systems, and tools. Identify opportunities to accelerate timelines and enhance data integrity and operational excellence.

Education, Experience, and Qualities Required:

• Advanced degree in life sciences, healthcare, or a clinically relevant field (PhD, PharmD, or MD preferred)
• Minimum 8+ years of clinical research experience, including Phase I to III clinical trials, ideally in neuropsychiatric and neurodegenerative disorders or other major therapeutic area
• Comprehensive understanding of drug development, medical data review, and regulatory environment
• Demonstrated proficiency in clinical data collection systems (e.g., Medidata RAVE, REDCap, or other industry-standard EDC systems) and familiarity with process improvement initiatives
• Excellent scientific communication, analytical, and organizational skills
• Collaborative and proactive mindset that thrives in a small biotechnology environment
• Passion for bringing new therapies to serve patients with unmet medical needs

If interested, please contact Human Resources (hr@lealtx.com) with a brief statement of interest and resume.