Summary/ Overview:

Lead and execute late stage discovery and early development activities, with a focus on progressing candidates from preclinical stage through IND filing and into early clinical (Phase I/II) studies, working as a senior individual contributor and project leader within the discovery/early development organization.

Key Responsibilities

• Design, plan and execute studies to support IND enabling packages, including pharmacology, DMPK, safety and translational biology inputs
• Coordinate cross functional activities between discovery, non clinical, CMC and clinical teams to ensure readiness for IND/CTA submissions
• Prepare and review scientific sections of regulatory documents (e.g., Investigator’s Brochure, IND/CTA modules, briefing documents) in collaboration with regulatory affairs
• Interpret complex in vitro and in vivo data sets, integrate findings and provide clear recommendations on candidate selection and risk mitigation
• Serve as study or project lead for one or more programs, driving timelines, tracking deliverables and ensuring high quality documentation and data integrity
• Contribute to clinical development plans and early phase protocol design, including dose selection rationale, biomarker strategy and translational hypotheses
• Present program updates and key data to internal governance forums and external partners as required
• Mentor junior scientists in experimental design, data analysis and best practices in documentation and compliance
• Stay current with scientific and regulatory trends relevant to drug discovery, IND preparation and early clinical development

Skills Required

• Demonstrated ability to design scientifically sound studies that directly support regulatory and clinical decision making
• Solid knowledge of regulatory expectations for IND/CTA packages and experience working with cross functional and regulatory teams
• Strong data analysis and interpretation skills, with the ability to synthesize multidisciplinary data into clear conclusions and next steps
• Effective written and verbal communication skills, including experience authoring reports and contributing to regulatory documents
• High level of ownership, attention to detail and ability to manage multiple studies or projects in parallel
• Strong understanding of the end to end discovery to IND process, including pharmacology, DMPK, basic toxicology concepts and CMC interfaces