VP of Clinical Development
Equillium
Summary
The Vice President, Clinical Development, I&I will provide medical and strategic leadership for Equillium's clinical portfolio, with primary responsibility for the clinical development of EQ504 in ulcerative colitis and pulmonary indications, as well as secondary support for EQ302 in celiac disease.
Job description
Position Overview
The Vice President, Clinical Development, I&I will provide medical and strategic leadership for Equillium's clinical portfolio, with primary responsibility for the clinical development of EQ504 in ulcerative colitis and pulmonary indications, as well as secondary support for EQ302 in celiac disease.
Essential Duties and Responsibilities
- Lead the integrated clinical development strategy and clinical development plan for EQ504 in ulcerative colitis, including indication strategy, target product profile, evidence-generation plan, decision criteria, timelines and budgets.
- Provide medical leadership for the ongoing EQ504 Phase 1 proof-of-mechanism study, including protocol execution, dose and regimen evaluation, safety monitoring, data review, interpretation and communication of results.
- Lead the planning and design of a Phase 2 study in patients with ulcerative colitis to follow the Phase 1 study, including development of the protocol and statistical framework, patient population and eligibility criteria, dose and regimen selection, endpoints, biomarkers, site and country strategy, operational feasibility, budget, timelines and regulatory alignment.
- Provide clinical development input for EQ302 in celiac disease.
- Lead development of clinical protocols, investigator brochures, clinical study reports, clinical sections of regulatory submissions and briefing materials for health authority interactions.
- Provide medical oversight of clinical trials, including eligibility and enrollment issues, protocol deviations, emerging efficacy and biomarker data, and aggregate safety assessment in partnership with Pharmacovigilance.
- Guide clinical pharmacology, biomarker and translational strategies that establish proof of mechanism, support Phase 2 dose selection and strengthen the differentiation of EQ504; advise on EQ302 selectively as needed.
- Contribute to portfolio, business development, financing and investor activities by clearly communicating program strategy, clinical rationale, development risks and value-creating milestones.
Key Measures of Success
- High-quality execution and interpretation of the EQ504 Phase 1 program and a Phase 2 ulcerative colitis study that is designed, operationally feasible and ready to initiate following supportive Phase 1 results.
- Focused, fit-for-purpose clinical development support for EQ504 pulmonary indications and EQ302 for celiac disease.
- Timely delivery of clinical and regulatory milestones with disciplined risk management and transparent communication.
- Strong engagement with leading gastroenterology investigators and advisors, and a compelling external scientific profile for the portfolio.
- Effective cross-functional leadership that aligns strategy, operations and decision-making.
Education and Experience
- M.D. or Ph.D. required.
- Board certification or advanced clinical training in gastroenterology is strongly preferred.
- Typically, 12 or more years of relevant biopharmaceutical clinical development experience, including meaningful leadership responsibility for I&I programs.
- Demonstrated expertise in inflammatory bowel disease, particularly ulcerative colitis; experience in celiac disease, immune-mediated gastrointestinal disorders, and/or pulmonary diseases is highly desirable.
Skills and Leadership Attributes
- Decisive, pragmatic, and comfortable operating hands-on in a dynamic fast-moving organization.
- Strategic, collaborative, low-ego leader who creates clarity and accountability.
- Ability to travel domestically and internationally up to approximately 25%.
Requirements
- M.D. or Ph.D. required
- Board certification or advanced clinical training in gastroenterology strongly preferred
- Typically 12 or more years of relevant biopharmaceutical clinical development experience
- Meaningful leadership responsibility for I&I programs
- Demonstrated expertise in inflammatory bowel disease, particularly ulcerative colitis
- Experience in celiac disease, immune-mediated gastrointestinal disorders, and/or pulmonary diseases highly desirable
- Ability to travel domestically and internationally up to approximately 25%
Company overview
Equillium is a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical needs. The company's pipeline is centered around targeting key immune pathways involved in these conditions, with a particular emphasis on T-cell mediated diseases. Equillium's lead product candidate is itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM pathway, which plays a critical role in modulating T-cell activation and trafficking. The company is advancing itolizumab through clinical development for multiple indications including acute graft-versus-host disease, lupus nephritis, and other autoimmune conditions. Equillium employs a targeted approach to drug development, leveraging deep understanding of immunology to identify and validate novel therapeutic targets. The company operates with a lean organizational structure while maintaining scientific rigor in its clinical development programs, aiming to bring innovative treatments to patients suffering from debilitating immune-mediated diseases.