Clinical Trial Site Activation Lead

About Celea Therapeutics Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Rising above the status quo takes a team as strong as its science, and we hire and work by five values: accountability — owning outcomes and acting like owners; transparency — talking straight and building trust; collaboration — achieving together what no one could alone; innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission. Position Overview As we prepare for our next stage of growth and clinical advancement, Celea is seeking a highly motivated, strategic, and hands-on Clinical Trial Site Activation Lead to drive the strategic planning, coordination, and execution of late-stage clinical trial start-up activities. Reporting to the Vice President of Clinical Operations, this role will own the journey of each clinical site from initial feasibility and regulatory/IRB/EC submission through site initiation and readiness for patient enrollment. Acting as the central operational liaison, you will bridge sponsors, clinical sites (largely via CRO), and legal teams to accelerate timelines and ensure full compliance with ICH-GCP guidelines. In this highly visible role, you will have exposure to our senior leaders, be integral in the decision-making process, and be at the forefront of scientific innovation and business growth. In the near term, the focus will be activating sites for our late-stage global clinical trial(s) — accelerating start-up timelines while keeping quality and compliance on track. Over time, this person will help build the site activation processes, standards, and team that will scale with the company, and will be instrumental in guiding Celea through its next chapter. This posi tion is hybrid or remote friendly . Key Responsibilities Lead the development and implementation of global site activation plans. Oversee site identification, pre-study evaluations, and feasibility assessments to optimize site selection. Facilitate the preparation, review, and tracking of regulatory and essential documents (e.g., FDA Form 1572, IRB/IEC packages, Informed Consent Form adaptations). Drive the negotiation of clinical trial agreements and site budgets in partnership with CRO, legal, and clinical stakeholders. Track and report on start-up Key Performance Indicators (KPIs), proactively identify bottlenecks, and implement risk mitigation strategies to keep the study on schedule. Serve as the primary point of contact for investigative sites, investigators, and clinical teams during the start-up phase, and lead and/or support cross-functional start-up project team meetings. Ensure all start-up activities align with protocol requirements, sponsor expectations, standard operating procedures (SOPs), and prevailing global regulations, and ensure eTMF inspection readiness for start-up documentation. Support site readiness for regulatory audits and inspections, contributing to Corrective and Preventive Action (CAPA) plans, if needed. Mentor, train, and oversee junior site activation staff, as applicable. Qualifications Required Bachelor's degree in Life Sciences, Health Sciences, or a related field; equivalent experience considered. Minimum of 4–6 years of relevant experience in clinical research, with a strong focus on clinical site start-up, regulatory submissions, or trial management. Deep understanding of ICH-GCP guidelines, global regulatory requirements, and local ethics committee submissions. Proven ability to manage multi-country or high-volume clinical study start-up activities and cross-functional teams, with exceptional negotiation, risk-resolution, and written/verbal communication skills. Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment. Proficiency using AI tools to work smarter — curiosity about how technology can improve the quality and speed of your work. Preferred Familiarity with clinical trial technologies. Experience supporting late-stage (Phase 3) global clinical trials. Why Join Celea Therapeutics Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases. Shape the foundation of a Phase 3–ready biotech poised for significant growth. Collaborate with a passionate, mission-driven leadership team. Competitive compensation and equity package. Compensation Transparency is one of our values, and that includes how we pay. The anticipated salary range for this role is $ 205,000 - $240,000 , plus bonus and equi ty. Where an offer lands within the range reflects the candidate’s experience, skills, and internal equity — and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage. Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation. Base Pay Information $205,000 — $240,000 USD Our Commitment Celea Therapeutics is an equal opportunity employer. We evaluate every candidate against the requirements of the role using a structured, evidence-based process, and we make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic. For more information, visit www.celeatx.com or connect with us on Twitter @celeatx.