Clinical Operations Manager

3Helix is a biotechnology company pioneering a new therapeutic approach based on Collagen Hybridizing Peptides (CHPs), a proprietary platform designed to target and modulate damaged collagen within diseased tissues. Our therapeutic pipeline is focused on advancing collagen-targeted medicines for diseases driven by chronic inflammation, tissue remodeling, and fibrosis. Current programs include engineered bioACTIVE CHPs (BA-CHPs) designed to deliver targeted immunomodulatory activity and address unmet medical needs. 3Helix is entering a stage of growth as we advance our lead therapeutic programs into clinical development. Following years of platform development, preclinical validation, and translational research, we are preparing for upcoming Phase Ia and Phase Ib clinical trials to evaluate the safety, tolerability, pharmacokinetics, and early biological activity of our novel collagen-targeted therapeutic candidates. The Clinical Operations Manager will join 3Helix at a pivotal point in our evolution from preclinical development into a clinical-stage biotechnology company. This individual will lead operational execution of our first-in-human Phase Ia and Phase Ib therapeutic clinical trials, partnering closely with internal teams, clinical investigators, CROs, and external vendors to ensure successful study delivery. The ideal candidate is an experienced clinical operations professional who thrives in an entrepreneurial biotech environment and has demonstrated success managing early-phase clinical trials from study start‑up through execution. KEY RESPONSIBILITIES Clinical Trial Operations Lead day-to-day operational management of Phase Ia/Ib clinical trials, including planning, execution, monitoring, and close-out activities. Partner with VP of Clinical Operations and Medical Director to develop clinical trial timelines, milestones, budgets, and operational plans. Partner with CROs and Medical teams to support protocol development, study design, and clinical execution. Manage clinical trial documentation, including study plans, monitoring plans, informed consent documents, essential documents, and trial master file (TMF) oversight. Ensure clinical activities are conducted in accordance with ICH-GCP, HREC regulations, company SOPs, and applicable ethical standards. Serve as the primary operational contact for CRO partners and clinical vendors. Provide oversight of CRO performance, timelines, deliverables, quality metrics, and budgets. Support selection, qualification, and management of clinical trial vendors, including central laboratories, specialty testing providers, and other clinical service providers alongside VP of Clinical Operations. Review vendor invoices, contracts, and scope changes. Clinical Site Management Support clinical site identification, qualification, initiation, and activation activities. Develop strong relationships with investigators and clinical site teams. Ensure timely enrollment, patient retention, protocol compliance, and data quality. Track enrollment metrics, safety reporting timelines, and study milestones. Clinical Trial Infrastructure Development Help establish and scale 3Helix clinical operations processes, systems, and SOPs. Contribute to development of clinical operations best practices as the company advances its pipeline. Support preparation for future clinical development programs and regulatory milestones. FINANCIAL RESPONSIBILITIES The Clinical Operations Manager has financial accountability for the operational execution of assigned clinical trials. This includes supporting clinical trial budget development, tracking study-related expenses, reviewing CRO and vendor invoices, monitoring project scope and change orders, and identifying potential cost risks or budget variances. This position works closely with leadership and external partners to ensure clinical activities are executed efficiently within approved budgets. CROSS FUNCTIONAL COLLABORATION This position interacts with all levels of the organization and serves as a key cross-functional partner supporting 3Helix’s transition into a clinical-stage biotechnology company. The Clinical Operations Manager will collaborate regularly with Regulatory Consultants, Research & Development, Medical Affairs, Finance, and executive leadership. Externally, this role will serve as a primary operational contact for CRO partners, clinical investigators, clinical sites, laboratories, and other clinical vendors. The ideal candidate will demonstrate strong communication skills, professionalism, and the ability to build effective partnerships across internal and external teams. CLINICAL OPERATIONS LEADERSHIP The Clinical Operations Manager will provide operational leadership for 3Helix’s clinical programs, applying clinical research expertise and independent judgment to drive successful execution of Phase Ia and Phase Ib trials. This individual will proactively identify risks, develop solutions, prioritize resources, and make recommendations that support trial timelines, quality, compliance, and overall program objectives. The Clinical Operations Manager will be responsible for managing operational decisions related to CRO and vendor coordination, study timelines, enrollment activities, documentation requirements, and clinical trial execution while appropriately escalating strategic risks and decisions to leadership. JOB REQUIREMENTS Required Qualifications Bachelor’s degree in life sciences, healthcare, nursing, or related field; advanced degree preferred. 3+ years of clinical operations experience in biotechnology, pharmaceutical, or CRO environments. Experience managing Phase I and/or Phase Ib clinical trials. Experience working with CROs and external clinical vendors. Strong knowledge of ICH-GCP, HREC or FDA regulations, and clinical trial processes. Demonstrated ability to manage timelines, budgets, risks, and competing priorities. Excellent organizational, communication, and problem-solving skills. Preferred Qualifications Experience supporting first-in-human trials. Experienced in compliance for human trials and non-clinical development. Experience with HREC or IND submissions and early regulatory interactions. Experience managing dermatology, immunology or inflammatory disease programs. Experience working in a small biotech environment with hands-on operational responsibilities. Familiarity with clinical trial systems, including CTMS, EDC, eTMF and safety databases. COMPANY BENEFITS Competitive salary range Gym and education stipends available Unlimited paid time off (PTO). Flex scheduling (after introductory period). Full coverage of health, vision, and dental insurance for employees and dependents. Company stock options. Potential travel for conferences. MORE ABOUT 3HELIX At 3Helix, we are revolutionizing the way the world understands and interacts with collagen. Since our founding in 2015, we have been driven by the belief that collagen is the key to unlocking major breakthroughs in human disease. From our headquarters in Salt Lake City, Utah, we have pioneered innovative technologies, most notably our proprietary bioACTIVE Collagen Hybridizing Peptide (CHP) platform, which enables the precise modulation and targeting of collagen-driven disease processes. Our Mission & Vision Mission: To translate breakthrough science on damaged collagen into life-changing medicines for patients. Vision: A future where diseases driven by extracellular biology are effectively treated. The Team & Culture You're Joining By joining 3Helix at this pivotal clinical transition, you are coming aboard a lean, fast-paced, and deeply collaborative team. We pride ourselves on cultivating an entrepreneurial environment where every voice matters and your daily impact is tangible. We are guided by a shared commitment to a set of defining core values: Relentless Inquiry: We pursue scientific excellence through rigorous exploration, discovery, and a passion for redefining what is possible in biotechnology. Collective Achievement: We believe deeply in the power of collaboration. We work seamlessly across internal cross-functional teams and forge strong external alliances to achieve extraordinary results. Dedicated Ownership: We take absolute ownership of our work. We approach challenges with an unyielding effort, grit, and a solutions-oriented mindset in pursuit of our shared vision. Accountability: We build trust through unwavering accountability and maintain an uncompromising ethical foundation in every aspect of our work, from laboratory discovery to clinical data compliance. #J-18808-Ljbffr