This is an opportunity to be the founding clinical operations leader at a company where your work will shape both the science and the organization.

Position Overview:

As Paratus Sciences' first dedicated clinical operations hire, you will own the end-to-end delivery of our clinical pipeline. This is not a role for a process follower, it is a role for a dynamic builder and operator who can translate a clinical development strategy into executable programs, establish the infrastructure that scales with us, and lead with equal parts strategic judgment and hands-on accountability.

You will be the operational backbone of our most critical near-term milestones across two pipeline programs. You will define how we work with CROs, how we govern our vendors, how we manage risk, and how we build the team that carries us through Phase 2 and beyond.

This role reports to the Head of Clinical Development and is initially an individual contributor position with an opportunity to build and scale the clinical operations team as the pipeline advances.

This position is based in Boston, Massachusetts, with an expectation of working in the office a minimum of two days per week. Flexibility to work across global time zones is required.

Role Description:

Study Execution & CRO Governance
Lead the full lifecycle of clinical trial execution from CRO and vendor selection, through contracting, study startup, site management oversight, and study close-out. Own the sponsor-side CRO relationship across the current pipeline, including our lead Phase 1 FIH program (healthy volunteers and patients) and the next program advancing toward IND and FIH, with accountability for timelines, budgets, and quality standards. Assess study feasibility, develop cost estimates, and provide input into contracts, work orders, and change orders in support of outsourcing decisions.

Create and execute clinical operational strategic plans aligned with product strategy and resource allocation, translating development objectives into executable, resourced program plans.

Operational Infrastructure
Build the clinical operations foundation Paratus will scale on: SOPs, vendor qualification frameworks, oversight plans, and a risk-based monitoring approach. You will establish practices that are fit-for-purpose today and structured to grow as the pipeline expands.

Budget & Finance Partnership
Manage clinical trial budgets and forecasts across programs. Partner closely with Finance on accruals, variance analysis, and program-level cost accountability. Proactively flag risks before they become surprises.

Risk Management & Program Momentum
Develop and execute risk mitigation strategies that protect program timelines. Represent clinical operations in cross-functional program discussions; serving as the operational voice on timelines, risks, trade-offs, and decisions.

Team Building
Identify, recruit, and develop the ClinOps team as the pipeline scales including CTMs, CRA oversight, study managers, and beyond. Model a high-performance culture that is inspection-ready, compliant, and mission-driven.

Regulatory & Quality Compliance
Ensure all studies are executed in accordance with ICH-GCP, FDA/EMA regulatory requirements, and internal SOPs.

Qualifications:

• 10+ years of clinical operations experience in biotech or pharma, with direct sponsor-side CRO management experience

• Demonstrated track record leading early phase trials, including FIH and Phase 1/2 studies;

• Proven ability to manage CROs and cross-functional clinical programs end-to-end from vendor selection through study close-out

• Deep command of ICH-GCP, FDA/EMA regulatory requirements, and global clinical trial execution

• Working proficiency with clinical systems (CTMS, eTMF, EDC) and their role in study quality

• Strong vendor management, contract negotiation, and budget and timeline oversight track record

Preferred Background

• Prior experience as one of the first 3-5 clinical hires at a small biotech (under 50 FTE)

• Multi-program oversight experience managing two or more concurrent studies

• Direct experience building SOPs and clinical operations infrastructure from scratch

• Experience with Australian or APAC clinical trial execution (TGA, HREC, and the CTN scheme) strongly preferred

• Experience with rare, orphan, or basket/multi-cohort trial designs

• Prior experience supporting biologic programs (e.g., monoclonal antibodies) in addition to small molecules

Education

• BS/BA in life sciences, nursing, or a related field required

• Advanced degree (MS, PharmD, RN) preferred; equivalent demonstrated experience will be considered