Director, Early Development at iBio, Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

239400.0

Posted On

02 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biologics, Bioanalytical Assays, Program Leadership, Regulatory Activities, Clinical Development, Cross-Functional Collaboration, Risk Mitigation, Technical Expertise, Strategic Leadership, Project Management, Vendor Management, Communication, Scientific Judgment, Integrated Program Plans, Assay Planning, Toxicology

Industry

Biotechnology Research

Description

Description About iBio iBio is an AI-driven innovator developing therapies for cardiometabolic, obesity and cardiopulmonary diseases,. iBio’s mission is to decrease drug failures, shorten development timelines, and open up new frontiers against the most promising therapeutic targets. iBio is based in San Diego, CA. For more information, visit www.ibioinc.com. 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. Requirements Experience 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. Knowledge and Skills Required: 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. Preferred: Experience supporting antibody or related therapeutics in cardiometabolic disease, cardiopulmonary disease, obesity, or related therapeutic areas. Familiarity with early clinical development considerations for biologics, including translational and operational support for first-in-human studies. Self-motivated, entrepreneurial mindset, with comfort operating in a fast-paced environment with urgency and ambiguity. California Base Salary Range The expected annual base salary for this position ranges from $180,600.00 to $239,400.00, plus bonus, equity, and comprehensive benefits. The base salary range reflects the target range for this position, but individual pay will be determined by various factors, including the qualifications of the individual applicant for the position, years of relevant experience, job-related skills, relevant education attained, work location, and organizational needs. This range may be modified in the future. A discretionary annual bonus may be available based on individual and Company performance. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected classes. What do we offer? We provide competitive and comprehensive benefits to our employees. Below are some highlights of our 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 EEO Statement iBio is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. iBio is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at iBio, please email ibio_peopleculture@ibioinc.com for further assistance. Please note that this email address is intended only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Notice to Recruiters Thank you for your interest in iBio and our recruitment opportunities. Recruiting and employment are managed through the Human Resources Department. iBio requires a signed agreement be in place prior the presentation of any candidates. We ask that recruiters and agencies do not contact or solicit employees or managers in an attempt to present candidates. iBio will not be obligated or responsible for any requested fees to candidate resumes that are unsolicited and or submitted to hiring managers without a written agreement between iBio and any recruiters and agencies.

Responsibilities

Lead development programs from late discovery through IND-enabling studies and into first-in-human clinical testing. Drive cross-functional program execution across bioanalytical, nonclinical, CMC, regulatory, and clinical functions.