Associate Director, Clinical Operations (Unblinded)

THE COMPANY Elion Therapeutics is a clinical-stage biotechnology company headquartered in Boston, with a hub in San Diego, developing a host-sparing antifungal platform for immuno-compromised patients. Named for Gertrude Elion, the Nobel-laureate chemist whose rational drug design pioneered life-saving medicines, the company brings together a world-class team of drug developers, including experts behind nearly every antifungal therapy approved over the past two decades and the most recently approved agent in the class. Elion’s lead asset, turletricin (EL219), is a next-generation polyene engineered to retain the broad, fungicidal potency of amphotericin B while sparing patients the toxicity and drug interactions that have constrained the class for decades. Turletricin is positioned to intervene earlier, before fungal infection can derail the curative-intent oncology care or chronic biologic therapy keeping immuno-compromised patients alive. POSITION OVERVIEW We are seeking an experienced and motivated Associate Director, Clinical Operations to join our growing team. This is a specialized and trusted role responsible for leading the unblinded operational activities across U.S. and Ex-U.S. blinded clinical trials, while also fulfilling core Associate Director responsibilities. The AD, Clinical Operations serves as the primary Sponsor point of contact for all unblinded trial activities including oversight of unblinded CRO teams, clinical site pharmacies, investigational product (IP) management, and randomization/IXRS operations.This role also ensures adherence to GCP and applicable regulations and procedures, as well as protocol compliance and compliance with study-related plans. The role is accountable for ensuring high quality deliverables within timelines and budget. KEY RESPONSIBILITIES Clinical Trial ManagementSupport protocol authoring, eCRF development, and Clinical Study Report preparation, and partner with the study management team in assessing site feasibility for site selection.Oversee the development and review of study-related documents, processes, and manuals that interface with unblinded activities. (e.g., Site Specific Blinding Plans, Pharmacy Manual, Study Reference Binder, etc.).Prepare Requests for Proposals documents (RFP’s) and soliciting bids from CROs and vendors, evaluating the submitted proposals for merit and fit, and developing a rationale for selecting a preferred vendor with the Clinical Operations Team.Manage vendor agreements for outsourced activities, including vendors’ adherence to the scope of service agreements, budgets, plans and timelines, ensuring that change orders to the work scope and budgets meet clinical operations specifications.Support preparation and management of clinical study budgets and timelines. Provide oversight, direction, and serve as the Sponsor escalation point for an unblinded CRO team (i.e. unblinded CRAs and CTMs), including but not limited to activities such as:Unblinded monitoring oversight, including unblinded site trip report reviewsServe as the liaison to the sponsor Clinical Supply team and IXRS vendor for dosing issuesResolve pharmacy manual and associated Investigational Product (IP) questionsOversee and maintain the unblinded eTMFServe as the Sponsor point of contact for clinical trial site pharmacies and unblinded teamsTrack and document potential/actual unblinding events to completionPartner with Clinical Supplies and Clinical Operations to ensure appropriate setup of the IRTS/IXRS (if applicable) and randomization specifications, adequate IP supply for each study site, and prompt resolution of supply issues.Participate in periodic study management team risk reviews. Ongoing identification of unblinded areas of concern and/or risks, with escalation to the blinded lead and study management.Support the Quality Assurance team in their audits of unblinded study components.Provide input and review of SOPs, Work Instructions, and guidelines.Coordinate and manage various unblinded tasks in collaboration with other sponsor roles to achieve site readiness, such as preparing study materials and obtaining approval for drug shipping/receipt in accordance with procedure.Perform unblinded remote, on-site monitoring and oversight activities using tools to ensure: Clinical document control activities and associated study staff to ensure the content and management of the electronic/paper unblinded Trial Master File (eTMF/TMF) content is current and inspection-ready.Periodic reviews of the unblinded eTMF/TMF content sections to ensure adherence with standards and compliance with the relevant regulations and guidelines.Track and coordinate unblinded trial-related material availability and resupply, including clinical trial supplies and laboratory samples.Support risk management initiatives. Cross-Functional CollaborationPartner with Nonclinical, Quality, and CMC teams to align clinical operations activities with regulatory requirements.Communicate clearly across departments to support a shared understanding of clinical trial deliverables and timelines.Collaborate cross-functionally, uphold and role-model Elion’s Cultural Principles of Ingenuity, Collaboration, Open Communications, and Net Accountability (ICON). QUALIFICATIONS Bachelor’s degree in a scientific discipline or healthcare field; a combination of relevant education and applicable job experience may be considered.8+ years of direct work experience in Clinical Research, with pivotal trial (e.g., Phase 2, 3) experience in an unblinded role from study start-up through closeout preferred.Able to manage multiple tasks, information, and deadlines; identify risks and issued taking appropriate action.Self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including cross-organizational impact and compartmentalizing between blinded and unblinded information to maintain the integrity of the study blind and randomization.Excellent planning, organizational, and communication skills, with a high-quality, compliance-focused mindset. Ability to build and maintain solid relationships with management, peers, and clinical sites.Travel up to 20% with overnight stays.Boston or San Diego-based preferred. WHAT WE OFFER A science-first culture where the Clinical Ops function is viewed as a strategic partner.A collaborative, mission-driven leadership team with deep domain expertise and a shared commitment to bringing better therapies to patients with serious infectious diseases.Competitive base salary benchmarked to biotech clinical operations market rates in the Boston/Cambridge/CA life sciences ecosystems.Meaningful equity participation.Performance-based bonus tied to company and individual objectives.Comprehensive benefits including medical, dental, vision, health wellness reimbursement, unlimited PTO, and 401(k) with company matching.