Director/Sr Director Clinical Operations Lead
Overview
You will own the end-to-end delivery of our clinical pipeline as Paratus Sciences' first dedicated clinical operations hire. This includes leading the full lifecycle of trial execution across two pipeline programs, with the lead Phase 1 FIH study and a second program advancing toward IND and FIH. You will build the clinical operations foundation, define CRO governance, and manage budgets and risk. Reporting to the Head of Clinical Development, you will start as an individual contributor and build the team as we scale through Phase 2 and beyond. This role stands out because you will shape the science and the organization from the ground up.
What You'll Do9
- 1Lead the full lifecycle of clinical trial execution, from CRO and vendor selection through contracting, study startup, site management, and close-out for two programs.
- 2Own the sponsor-side CRO relationship, ensuring accountability for timelines, budgets, and quality across the Phase 1 FIH program and the next program toward IND.
- 3Assess study feasibility, develop cost estimates, and provide input into contracts, work orders, and change orders to support outsourcing decisions.
- 4Create and execute clinical operational strategic plans aligned with product strategy, translating development objectives into executable, resourced program plans.
- 5Build the clinical operations infrastructure, including SOPs, vendor qualification frameworks, oversight plans, and a risk-based monitoring approach.
- 6Manage clinical trial budgets and forecasts, partnering with Finance on accruals, variance analysis, and program-level cost accountability.
- 7Develop and execute risk mitigation strategies to protect program timelines, representing clinical operations in cross-functional discussions.
- 8Identify, recruit, and develop the ClinOps team as the pipeline scales, including CTMs, CRA oversight, and study managers.
- 9Ensure all studies are executed in accordance with ICH-GCP and FDA/EMA regulatory requirements and internal SOPs.
Requirements12
- 110+ years of clinical operations experience in biotech or pharma, with direct sponsor-side CRO management experience.
- 2Demonstrated track record leading early phase trials, including FIH and Phase 1/2 studies, with end-to-end CRO and vendor management.
- 3Deep command of ICH-GCP and FDA/EMA regulatory requirements and global clinical trial execution.
- 4Working proficiency with clinical systems: CTMS, eTMF, and EDC.
- 5Strong vendor management, contract negotiation, and budget and timeline oversight track record.
- 6Experience as one of the first 3-5 clinical hires at a small biotech (under 50 FTE) preferred.
- 7Multi-program oversight experience managing two or more concurrent studies preferred.
- 8Direct experience building SOPs and clinical operations infrastructure from scratch preferred.
- 9Experience with Australian or APAC clinical trial execution (TGA, HREC, CTN scheme) strongly preferred.
- 10Experience with rare, orphan, or basket/multi-cohort trial designs preferred.
- 11Prior experience supporting biologic programs (e.g., monoclonal antibodies) in addition to small molecules preferred.
- 12BS/BA in life sciences, nursing, or a related field required; advanced degree (MS, PharmD, RN) preferred.
Salary Insight
$180 - $275k per year
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