Director/ Sr Director, Clinical Operations

We are a stealth-stage biopharmaceutical company on a mission to improve outcomes for patients living with obesity and cardiovascular disease — two of the most prevalent and burdensome conditions worldwide. We are advancing a differentiated pipeline grounded in compelling biology and a deep commitment to patient outcomes. With robust preclinical data in hand and IND-enabling studies underway, we are building the clinical and operational infrastructure to take our lead program into first-in-human (FIH) studies. Backed by experienced investors and led by a team of seasoned drug developers, this is a rare opportunity to join at the ground floor and directly shape the trajectory of the company.

THE OPPORTUNITY

The Director / Senior Director of Clinical Operations will serve as the hands-on study lead for the company's first-in-human program — the person most directly responsible for making the trial happen. Reporting to the VP of Clinical Operations, this role is the operational engine of the FIH study: owning day-to-day execution, managing CRO and site relationships, driving timelines, and ensuring every aspect of the trial is delivered to the highest quality standards. This is an ideal role for an experienced clinical operations professional who thrives on direct accountability, loves the excitement of initiating early-phase trials, and wants to be impactful for patients. You are organized, proactive, and hands-on — equally comfortable digging into a monitoring report and presenting a risk mitigation plan to senior leadership. You may also have the opportunity to grow into broader leadership responsibilities as the company scales.

KEY RESPONSIBILITIES

Serve as the primary study lead for the company's FIH program — the single point of operational accountability for trial startup, execution, and closeout Own and manage the integrated study timeline, risk register, and enrollment forecasting models; proactively identify and resolve operational risks before they impact the critical path Lead cross-functional study team meetings; ensure alignment and clear ownership across clinical operations, data management, pharmacovigilance, bioanalytical, and regulatory affairs Drive study startup activities including protocol operationalization, study plan development (monitoring plan, communication plan, data management plan), and TMF setup Implement and champion ICH E6(R3) GCP compliance and quality standards across all study activities; ensure the trial is inspection‑ready at all times Serve as the day-to-day operational lead for all CRO and vendor relationships; hold partners accountable to timelines, deliverables, quality, and budget Review and approve key CRO deliverables including monitoring visit reports, site activation packages, data listings, and escalation reports Identify and elevate vendor performance issues early; work with the VP of Clinical Operations on corrective action plans as needed Support CRO and vendor selection processes, contributing operational insight and feasibility expertise Site Management & Oversight Oversee site activation, patient enrollment, and ongoing site performance for all FIH study sites Maintain strong working relationships with principal investigators, site coordinators, and Phase 1 unit staff Review monitoring reports and data trends; ensure issues are identified, escalated, and resolved in a timely manner Support country and site setup activities, including feasibility assessments, ethics submissions, and site contracting Team & Operational Support Manage and mentor junior clinical operations staff (CTMs, CRAs) as the team grows; foster a culture of accountability, precision, and patient focus Contribute to the development of SOPs, templates, and operational processes that will form the foundation of the company's clinical infrastructure Support pre-IND operational planning activities, including protocol development input, vendor scoping, and country/site feasibility assessments Manage the study budget and track expenditures against forecast; flag variances and support re‑forecasting as needed

QUALIFICATIONS

Required 7+ years of clinical operations experience in biopharmaceutical, biotech, or CRO settings, with direct hands‑on experience in early‑phase (Phase 1) clinical trials Experience serving as a study lead or primary operational owner for Phase 1 FIH trials, including SAD/MAD study designs; demonstrated personal accountability for trial execution from startup through closeout Broader Phase II/III experience required to bring full‑spectrum operational perspective and anticipate downstream trial needs Proven track record managing CROs and external vendors as a sponsor‑side representative; CRO‑only experience without sponsor‑side accountability will not be sufficient Experience managing or mentoring junior clinical operations staff (CTMs, CRAs) in a sponsor setting Strong working knowledge of GCP (ICH E6 R2/R3), IND/CTA regulatory frameworks, and clinical quality systems Excellent organizational skills and attention to detail; demonstrated ability to manage complex timelines, risk registers, and study budgets simultaneously Experience in obesity, cardiovascular disease, or adjacent metabolic therapeutic areas preferred Collaborative, proactive communicator who can represent clinical operations clearly to both internal teams and external partners Preferred Experience working at a sponsor company in a startup or early‑stage biotech environment Familiarity with ex‑US FIH regulatory pathways; direct experience initiating and overseeing FIH studies in Australia (TGA CTN/CTA, HREC) is a strong plus Exposure to pre‑IND operational planning, including protocol development input and clinical operations readiness assessments Experience with biomarker‑intensive studies or metabolic phenotyping endpoints Bachelor's or advanced degree in life sciences field Level and Compensation will be commensurate with experience We are an equal opportunity employer committed to building a diverse and inclusive team. We welcome candidates from all backgrounds who share our passion for improving human health. #J-18808-Ljbffr Third Rock Ventures