Associate Director/Director, Nonclinical Development

POSITION SUMMARY:

This role will lead the planning and execution of nonclinical safety programs for Atalanta’s di-siRNA platform for treating severe neurological disease. This individual will be responsible for the outsourcing, monitoring, and interpretation of GLP and nonGLP safety studies to support successful regulatory submissions. This role will provide technical expertise and stage-appropriate guidance in toxicology and safety assessments for programs at all phases of early discovery through clinical development. The successful candidate will be highly collaborative, data-driven, and flexible with the demonstrated ability to work with both internal and external stakeholders.

RESPONSIBILITIES:

• In collaboration with external consultants, develop and implement nonclinical toxicology and safety studies (GLP and nonGLP) to support company timelines and goals.
• Responsible for the execution of nonclinical toxicology and safety studies, including CRO selection, CRO management, and data interpretation to ensure successful regulatory submissions.
• Work collaboratively with Research, Pharmacology, Bioanalytical, CMC, Regulatory, Clinical, and Program Management functions to ensure successful nonclinical study execution to support clinical development.
• Lead review of nonclinical study reports by internal and external stakeholders for regulatory submission.
• Serve as a subject matter expert during interactions with regulatory agencies
• Lead preparation and review of nonclinical safety documents for regulatory documents, including briefing books, INDs, CTAs, investigator’s brochures, and NDAs.
• Ensure compliance with global regulatory nonclinical regulations and guidance.
• Serve as the nonclinical representative for projects at all stages of discovery and development and provide stage-appropriate guidance to project teams.

QUALIFICATIONS:

• An advanced degree (i.e. MS, PhD, DVM or equivalent) in toxicology, pharmacology, pathology, biology or related discipline with a minimum of 8-10 years of experience is required.
• Extensive experience with nonclinical study design, execution, and interpretation to support successful regulatory submissions.
• Knowledge of FDA and global regulatory guidance and requirements related to nonclinical safety assessments.
• Extensive experience with nonclinical CRO management including CRO selection, study design, protocol drafting and reporting.
• Strong understanding of Good Laboratory Practices (GLP), standard operating procedures, and stage-appropriate quality assurance.
• Ability to make data-driven decisions and demonstrated flexibility to adapt to modifications in project plans.
• Experience writing and reviewing nonclinical regulatory submissions (i.e.INDs, NDAs, CTAs, IBs, briefing books, etc.).
• Excellent written and verbal communication skills with the demonstrated ability to work with external stakeholders including consultants, KOLs, and CROs.
• Excellent organizational skills and comfort with multi-tasking in a fast-paced environment. 
• Willing and able to travel up both domestically and internationally up to 10%