VP/Senior Director, Clinical Operations

NewLimit; South San Francisco (CA); On-site; USD 300,000 - 460,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

Paid parental leave

20 days PTO + holidays

Meals and snacks on-site

Job summary

NewLimit is seeking a VP/Senior Director of Clinical Operations to orchestrate our first clinical trials focused on reprogramming medicines for aging. You will lead trial execution across protocols, CROs, and startup activities in US, AUS/NZ, EU, UK, with a patient-centric mindset.

As a founding member of the clinical operations team, you will manage timelines, budgets, and metrics, navigate regulatory requirements, and build a high-performance team to accelerate development and regulatory

Qualifications

• 10+ years of industry experience in Clinical Operations.
• Proven ability to orchestrate trials with CRO partners.
• Recent experience managing first-in-human trials.
• Experience spanning US, Australia, NZ, EU, UK, Japan.
• Strong data-driven mindset with metrics and reporting.
• Experience budgeting, forecasting and resource planning for trials.

Responsibilities

• Lead clinical trial execution from protocol development to startup activities.
• Manage CRO selection and oversight across geographies.
• Ensure designs and execution maximize patient benefit and data value.
• Own trial timelines and budgets; build operations metrics.
• Address recruitment, cross-border logistics, regulatory compliance, staffing.
• Build and lead the founding clinical operations team.
• Support regulatory submissions and ongoing global compliance.

Skills

Clinical Operations

CRO Management

First-in-Human Trials

Global Trial Management

Metrics & Reporting

Budgeting & Forecasting

Education

Life sciences degree

Job description

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