Aimed at senior clinical operations leaders who have managed first-in-human trials across multiple geographies and are ready to build a team from scratch.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Newlimit via Greenhouse
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.
Description
NewLimit is recruiting a VP/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. Learn more at: https://www.newlimit.com/careers *This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.
Source: Newlimit careers (Greenhouse)