Senior Clinical Trial Manager

Senior Clinical Trial ManagerCompany OverviewKalohexis is a clinical-stage biotechnology company that recently spun out of Endevica Bio to advance a broad portfolio of medicines targeting the central melanocortin system. The company brings together Endevica Bio’s melanocortin agonist and antagonist programs, including clinical and preclinical candidates for cachexia, obesity, and other metabolic conditions. Kalohexis may be a new name, but the science behind it is not new—the programs were discovered and developed by the Endevica Bio team, and the two companies continue to work closely together.Kalohexis is at an unusually exciting moment; our programs are advancing, our team is growing, and there is still plenty of room for each new colleague to shape the company’s future. This is small-biotech work in the best sense: things move quickly, people work across functions, and good ideas do not have to travel through layers of internal decision making.We are seeking a Senior Clinical Trial Manager to lead day-to-day execution of our ongoing clinical trials and support planning for future studies. Our trials run through external CROs and vendors, and this role will own the study plans, timelines, operational follow-through, and partner coordination needed to keep them moving on time and within budget.This is a hands-on trial management role that includes travel and in-person site visits. The Senior Clinical Trial Manager will work with clinical operations leadership, CROs, investigators, and study coordinators to identify problems, recommend solutions, and follow actions through to completion. The right person understands study execution and site operations and takes initiative when progress stalls.Key ResponsibilitiesLead day-to-day site operations. Develop and maintain site-level operational plans, timelines, and milestones, and manage site budgets for assigned trials. Work closely with site teams, CROs, vendors, and internal colleagues to support site activation, enrollment, and ongoing study conduct, resolving operational issues and escalating risks that could affect site performance. Manage CROs and vendors. Serve as the primary day-to-day operational contact for assigned partners. Review performance and deliverables, challenge delays, propose improvements, and ensure agreed actions are completed. Escalate material issues with clear recommendations.Drive site start-up and study changes. Resolve barriers to activation and coordinate implementation of protocol amendments, including updates to site documents, budgets, contracts, systems, and training.Track performance and resolve risks. Monitor activation, screening, enrollment, study conduct, and data flow. Maintain risk and issue logs, investigate emerging problems, and coordinate corrective actions.Visit sites and resolve operational barriers. Travel to research sites, independently and alongside the CRO, to meet investigators and coordinators, understand workflows and patient logistics, and troubleshoot issues. Translate site feedback into actions with clear owners and deadlines.Support recruitment execution. Work with clinical operations leadership and site engagement colleagues to implement site-specific recruitment plans. Track actions and results, resolve operational obstacles, and support site education sessions.Manage budgets and contracts. Review invoices, forecasts, change orders, and site budget or contract updates. Work with clinical operations leadership, finance, and legal colleagues to resolve discrepancies and assess proposed changes.Maintain quality and readiness. Oversee essential trial documentation, review eTMF status, and follow up on missing records. Work with quality and CRO partners to address findings and maintain inspection readiness.Keep teams coordinated and concerns visible. Lead operational meetings, document decisions, and provide clear progress updates. Ensure site and CRO concerns are appropriately escalated and remain visible until resolved.Support future studies. Contribute to feasibility, vendor selection, study planning, and operational readiness. Help establish consistent processes and tools for a growing portfolio.QualificationsB.S. in a life science, nursing, health-related discipline, or a related field required; advanced degree preferred.5+ years of clinical research experience, including clinical trial management experience and independent responsibility for study delivery.Strong CRO and vendor management experience, gained within a sponsor organization or through CRO-side trial leadership, with a clear understanding of sponsor oversight responsibilities.Experience across multiple stages of trial execution, including site start-up, active conduct, protocol amendments, and closeout.Direct experience with in-person site visits and working with investigators and study coordinators. Prior CRA experience at a CRO or study coordinator experience preferred.Practical understanding of site workflows and patient logistics, with the ability to identify barriers and communicate effectively with physicians and site staff. Nursing experience preferred.Experience managing timelines, budgets, and operational risks, with the judgment to prioritize actions and follow issues through to resolution.Strong working knowledge of GCP and systems such as CTMS, eTMF, and EDC.Hands-on, proactive approach, comfortable identifying solutions and completing the detailed coordination required within a small biotech.Strong communication and project management skills, working effectively with external partners and internal colleagues.Experience in obesity, cachexia, metabolic disease, oncology, or international trials preferred.Ability and willingness to travel for in-person site visits, investigator meetings, and CRO or vendor meetings.This is an on-site position in Northbrook, IL. Travel is required, including in-person visits to research sites.The expected salary range for the position is $165,000–$200,000. Full-time employees may also be eligible for an annual bonus based on company and individual performance.Kalohexis also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health, vision, and dental insurance, flexible spending accounts, health savings accounts, retirement savings plans, life, and disability insurance programs, equity incentive plans, and paid and unpaid time away from work. Relocation assistance is available for eligible candidates relocating to the Northbrook, IL area.Kalohexis is an equal employment opportunity employer. We evaluate applicants without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or any other legally protected characteristics. We also consider applicants with criminal histories, consistent with applicable federal, state and local law.Kalohexis is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to people@kalohexis.com and let us know the nature of your request and your contact information.