Head of Clinical Development

About the role

The VP of Clinical Development will plan and execute NewLimit's first clinical trials. The company's most advanced assets aim to restore youthful hepatic metabolism and could benefit diverse populations with liver disease and metabolic dysfunction. Early stage programs also have potential for impact in renal and inflammatory disease indications.

Responsibilities

• Design and orchestrate clinical trials for reprogramming medicines
• Lead and collaborate with external partners on clinical development activities
• Create clinical trial protocols and author regulatory submissions
• Solve logistical bottlenecks in clinical studies
• Contribute to budgeting, goal setting, and technical review decisions as part of the executive team
• Build and manage a clinical development team from early stages to first-in-human dosing

Requirements

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

Pay

Compensation for the role will depend on a number of factors, including qualifications, skills, competencies, and experience.

Schedule

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