[Hiring] Director, Early Development @iBio, Inc.

Role Description

Join Our Growing Team as a Director of Early Development! We are seeking an exceptional candidate to serve as a cross-functional program leader for early development activities, integrating efforts across CMC, nonclinical toxicology, bioanalytical, and regulatory activities. This role will lead cross-functional program execution through IND-enabling studies and regulatory submission readiness, and will continue to support first-in-human and early clinical development activities as programs advance.

We're looking for someone who thrives in a dynamic environment and excels at fostering cross-functional collaboration across departments. You will take the lead in advancing our innovative drug development programs, guiding them through IND-enabling development and supporting the transition into early clinical studies.

If you're passionate about making a meaningful impact in the biotech industry and want to be part of a team that's shaping the future of medicine, we want to hear from you!

This role is preferably located in San Diego, CA., but may be open to remote for the right candidate.

Essential Duties

• Lead development programs from late discovery through IND-enabling studies and into first-in-human clinical testing.
• Provide technical expertise and strategic leadership on bioanalytical assay planning and execution, including PK, ADA, biomarker, and related assay activities, supporting both nonclinical and early clinical activities.
• Develop and present program updates, recommendations, and decision materials to senior leadership.
• Drive cross-functional program execution across bioanalytical, nonclinical, CMC, regulatory, and clinical functions.
• Oversee and manage external partners, including CROs, labs, and consultants, to ensure high-quality deliverables, timely execution, and clear accountability.
• Build and maintain integrated program plans, timelines, key milestones, and proactive risk-mitigation strategies.

Qualifications

• BS/BA in Biology, Toxicology, Biotechnology, or related field, with 12+ years of biotech/pharmaceutical industry experience. OR;
• MS/MA in Biology, Toxicology, Biotechnology, or related field, with 10+ years of biotech/pharmaceutical industry experience. OR;
• PhD in Biology, Toxicology, Biotechnology, or related field, with 7+ years of biotech/pharmaceutical industry experience.
• Demonstrated track record of advancing antibody therapeutics from late discovery through IND-enabling development and supporting transition into first-in-human clinical studies, preferably in cardiometabolic disease, cardiopulmonary disease, obesity, or related therapeutic areas.
• Proven cross-functional program leadership experience in a matrixed environment.
• Strong technical experience with bioanalytical assays for biologics or related modalities.
• Experience managing external vendors and contributing to regulatory filings.

Requirements

• Deep understanding of biologic drug development from late discovery through IND-enabling studies and into early clinical development.
• Strong cross-functional program leadership skills, including the ability to drive alignment, manage risk, and advance complex programs in a matrixed environment.
• Strong understanding of bioanalytical strategy for biologics, including PK, ADA, biomarker, and related assay considerations across nonclinical and early clinical development.
• Ability to develop integrated program plans, prioritize across competing activities, and proactively identify and mitigate key development risks.
• Excellent communication, collaboration, and scientific judgment, with the ability to influence cross-functional teams and present clearly to senior leadership.
• Strong working knowledge of the functions that support IND/IND-equivalent readiness, including nonclinical, CMC, bioanalytical, and regulatory activities.

Benefits

• Medical, Dental, and Vision Insurance Options
• Flexible Time Off
• Our company observes seven designated holidays each calendar year.
• 401(k) with Company Match as described in plan documents.
• Life and Disability Insurance
• Short-term and long-term disability insurance