VP/Senior Director, Clinical Operations

About the role

The VP/Senior Director of Clinical Operations will orchestrate and manage clinical trials for NewLimit’s first reprogramming medicines. These therapies aim to restore youthful metabolic, endothelial, and immune function, with early-stage programs showing potential for impact in renal and inflammatory disease indications.

Responsibilities

• Orchestrate and manage clinical trials for some of the world’s first reprogramming medicines
• Lead clinical trial execution through protocol development, CRO selection and management, and startup activities across multiple geographies (US, AUS/NZ, EU, UK)
• Collaborate with clinical development to ensure trial designs and execution provide maximum benefit to patients and maximum information per dollar
• Manage and own company-wide clinical trial timelines and budgets, construct and instrument clinical operations metrics
• Disentangle the inevitable operational challenges that arise in trial execution, such as debugging recruitment, cross-border logistics, regulatory compliance, and staffing
• Build and manage a bar-raising clinical operations team as the founding member
• Support regulatory submissions and ongoing global compliance obligations

Requirements

• 10+ years of industry experience in Clinical Operations and a Bachelor’s or advanced degree in the life sciences
• Recent experience managing first-in-human trials
• Recent experience managing trials across multiple geographies (US, AUS, NZ, EU, UK, Japan)
• Quantitative mindset — track metrics, report numbers, and drive for measurable improvements quarter-over-quarter
• Experience managing clinical trial budgets, forecasts, and resource planning

Nice to have

• Recent experience coordinating first-in-human trials in Australia and New Zealand
• Experience managing trials in metabolic disease and hepatology
• Experience recruiting a clinical operations team on a short time horizon
• History of developing nucleic acid medicines (mRNA, ASO, siRNA) and lipid nanoparticle (LNP)-vectored products

Benefits

NewLimit offers generous benefits to ensure our team can focus on our mission:

• Health, dental, and vision insurance
• 401(k) with company match
• Paid parental leave
• Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays
• Meals and snacks on-site

Compensation

The compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers