Head of Clinical Development

About the Company

NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells.

Responsibilities

• Lead and orchestrate clinical development activities in collaboration with external partners
• Create clinical trial protocols, author and own regulatory submissions, and contribute to regulatory interactions
• Solve logistical bottlenecks that block progress of clinical studies
• Serve as a member of the Executive Team and contribute to budgeting, goal setting, and technical review decisions
• Build and run a clinical development team as the company approaches first-in-human dosing

Requirements

• M.D. or equivalent clinical training
• Experience planning and orchestrating first-in-human trials
• Experience with both US FDA and ex-US regulatory agencies (e.g. Australian TGA)
• Deep knowledge of Good Clinical Practices (GCP)

Preferred Qualifications

• Experience in metabolic and liver disease therapeutic areas
• Experience leading a clinical development team across multiple therapeutic areas
• Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)
• Experience managing both early (Phase 1/2) and late-stage (Phase 3) clinical trials

Benefits

• Health, dental, and vision insurance
• 401(k) with company match
• Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays
• Paid parental leave
• Meals and snacks on-site