Director of Preclinical Development

Our client, a leading global biotechnology company focused on advancing next-generation cell therapies, is seeking a Director, Preclinical Development to join their Early-Stage Drug Development organization.This individual will be responsible for driving preclinical development strategies, overseeing IND-enabling activities, and ensuring successful cross-functional execution across research, nonclinical, and regulatory functions. The role requires a strong scientific background, exceptional project management skills, and experience guiding programs from discovery through IND submission.Key Responsibilities:Lead the design, coordination, and execution of preclinical development strategies to support IND submissions.Manage project plans, timelines, budgets, and resources across multiple preclinical programs.Collaborate with internal and external partners to ensure study alignment, data integrity, and regulatory compliance.Oversee CRO relationships and external partnerships, ensuring quality deliverables and adherence to study goals.Provide strategic input into program design and contribute to long-term development planning.Prepare and review key project documentation, reports, and regulatory materials.Identify risks, develop mitigation strategies, and drive continuous improvement across preclinical operations.Qualifications:PhD in Biology, Biochemistry, or related scientific field.10+ years of relevant industry experience, including 5–8 years in preclinical R&D within biotech or pharma.Proven experience leading IND-enabling studies, preferably in cell or gene therapy programs.Strong understanding of preclinical drug development, GLP regulations, and regulatory submission requirements.Demonstrated success managing multiple complex projects and cross-functional teams.Excellent communication and interpersonal skills for stakeholder engagement and collaboration.Experience working with CROs and managing external partnerships.Project management certification (e.g., PMP, PRINCE2) is advantageous.