Director / Senior Director, Clinical Operations

Company info

NewLimit is a biotechnology company working to radically extend human healthspan. We're developing medicines to treat aging by reprogramming the epigenome, a new therapeutic mechanism to restore youthful function in aged cells. We've built the world's leading experimental and artificial intelligence system to discover reprogramming medicines at massive scale. Our first products are focused on restoring youthful metabolic, endothelial, and immune function.

About the role

NewLimit is recruiting a Director / Senior Director of Clinical Operations to orchestrate and manage our first clinical trials. Our most advanced assets restore youthful hepatic metabolism and hold the potential to benefit diverse populations with liver disease and metabolic dysfunction. Our early stage programs have similar potential for impact in renal and inflammatory disease indications.

In this role, you will orchestrate and manage clinical trials for some of the world's first reprogramming medicines.

As part of the role, you will

• Lead clinical trial execution through protocol development, CRO selection and management, and startup activities across several 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 - 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
• History of orchestrating clinical trials through CRO partners with accountability for operational delivery
• Recent experience managing first-in-human trials
• Experience managing trials across multiple geographies (US, AUS, NZ, EU, UK, Japan)
• Quantitative mindset - you track metrics, report numbers rather than anecdotes, 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 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.