VP/Senior Director, Clinical Operations

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 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.
• Recent experience managing first-in-human trials.
• Recent 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.

Qualifications

• 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.
• Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays.
• Meals and snacks on-site.
• Competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO.

Pay

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.

Schedule

Learn more at: https://www.newlimit.com/careers