Job description
Role Summary**
The Clinical Site Liaison (CSL) is a field‑based scientific and operational leader responsible for strengthening investigator partnerships, supporting high‑quality clinical trial execution, and driving enrollment and retention across Phase II Immunology & Inflammation (I&I) programs, with a primary focus on inflammatory bowel disease (IBD). This role blends site-facing operational leadership with medical‑scientific fluency, ensuring investigators and site teams understand both the scientific rationale and the operational expectations behind complex I&I protocols. CSLs serve as a critical bridge between Clinical Operations, Clinical Development, and Medical Affairs, bringing regional insights, scientific clarity, and proactive problem-solving to accelerate enrollment and optimize study performance.
Key Responsibilities
**Site Engagement & Clinical Trial Execution **
- Build and maintain strong relationships with PIs, sub‑Is, coordinators, and research staff across gastroenterology centers and academic institutions.
- Serve as the primary sponsor-facing contact for assigned sites, providing both scientific and operational support.
- Develop and execute site‑specific enrollment action plans tailored to local patient flow, site capabilities, and competing trials.
- Monitor enrollment metrics in real time and proactively intervene when sites fall behind, escalating barriers and partnering cross-functionally to remove them.
- Identify and resolve site challenges efficiently, delivering a high level of service.
- Support site initiation, activation, and ongoing conduct through clear communication, scientific alignment, and operational readiness.
- Respond promptly to scientific and operational inquiries outside CRA scope, escalating appropriately.
- Ensure consistent trial execution across sites through tailored engagement strategies developed in partnership with Clinical Operations and CRO teams.
**Scientific Engagement **
- Deliver credible, compliant scientific discussions with investigators and site staff focused on I&I pathophysiology, immune pathways, mechanism of action, and endpoint rationale.
- Provide medical-scientific clarity to reduce protocol deviations and improve data quality.
- Support Medical Affairs in disseminating emerging clinical data and ensuring scientific consistency across site interactions.
- Identify emerging scientific trends, competitive developments, and unmet needs in I&I that may influence development strategy.
**Insight Generation **
- Capture scientific, operational, and competitive insights from sites, including enrollment barriers, investigator sentiment, protocol comprehension challenges, and competitive trial activity.
- Communicate insights to Clinical Development, Clinical Operations, and Medical Affairs to inform study design, evidence generation priorities, and ongoing trial strategy.
- Support development of site-facing materials (training decks, scientific briefs, FAQs, visit flow tools).
- Participate in investigator meetings, advisory boards, and scientific exchange activities.
Qualifications
- Bachelor’s degree required; advanced scientific or clinical degree strongly preferred (PharmD, PhD, MD, NP/PA, RN).
- 8–12+ years of experience in clinical research, clinical operations, or medical affairs.
- 3–5+ years in a site-facing role (CRA, MSL, CTM, Clinical Educator).
- Strong expertise in Immunology & Inflammation, with direct experience in autoimmune, inflammatory, or immune-mediated diseases; IBD experience strongly preferred.
- Demonstrated experience supporting Phase II or Phase III clinical trials.
- Proven ability to engage investigators, lead scientific discussions, and represent Medical Affairs in cross-functional settings.
- Exceptional communication skills with the ability to translate complex science into clear, compelling narratives.
- Comfortable operating in a fast-paced, high-growth biotech environment.
- Ability to travel ~60%.
- Seeking candidates in Boston or San Diego however location of role flexible based on level of experience.