VP of Clinical Development

Company Overview 

Equillium, Inc. (Nasdaq: EQ) is a biotechnology innovator with a mission to develop highly impactful therapies for serious autoimmune and inflammatory disorders. The company is building a focused, wholly owned pipeline of targeted therapeutics designed to address tissue inflammation and restore immune and barrier homeostasis.  Equillium’s lead program, EQ504, is an investigational potent and selective aryl hydrocarbon receptor (AhR) modulator with a multimodal, non-immunosuppressive mechanism of action. For ulcerative colitis, EQ504 is formulated as an oral, colon-targeted, delayed-release drug product. 

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%. 

Equal Opportunity 

Equillium is an equal opportunity employer. 

*This JD has been shortened.  Interviewing candidates will be provided the longer version upon advancing into the interviewing process. *