Newlimit
Director / Senior Director, Clinical Operations
South San Francisco. Posted 3 months ago
The role
You will orchestrate and manage clinical trials for reprogramming medicines. This includes leading trial execution, managing budgets and timelines, and building a clinical operations team.
What you will do
- Lead clinical trial execution through protocol development, CRO selection and management, and startup activities across several geographies
- 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
- Debug recruitment, cross-border logistics, regulatory compliance, and staffing
- Build and manage a clinical operations team
- Support regulatory submissions and ongoing global compliance obligations
Required qualifications
- 10+ years of industry experience in Clinical Operations
- 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
- 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
- Health, dental, and vision insurance
- 401(k) with company match
- Paid parental leave
- 20 days/year PTO plus holidays
- Meals and snacks on-site
About the company
NewLimit is a biotechnology company working to radically extend human healthspan. They are developing medicines to treat aging by reprogramming the epigenome.