NewLimit
Head of Clinical Development
South San Francisco, CA · Vp
Sponsorship not specifiedDetected 34 days ago
GCPBudgetingClinical TrialsFDA RegulatoryBioinformaticsCRISPRCollaboration
About the role
- Solve the inevitable logistical bottlenecks that block progress of our clinical studies.
- Serve as a member of NewLimit's Executive Team and contribute to budgeting, goal setting, and technical review decisions.
Responsibilities
- 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.
- In this role, you will design and orchestrate clinical trials for some of the world's first reprogramming medicines.
- Create clinical trial protocols, author and own regulatory submissions, and contribute to regulatory interactions.
- Build and run a clinical development team as we approach first-in-human dosing.
Requirements
- 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)
Nice to have
- Experience in metabolic and liver disease therapeutic areas
- Experience leading a clinical development team across multiple therapeutic areas
- Experience managing both early (Phase 1/2) and late-stage (Phase 3) clinical trials
Compensation
- for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience.
Benefits
- Health, dental, and vision insurance
- Industry-leading paid time off (PTO) -- 20 days/year for all employees + holidays
- Paid parental leave
- Our most advanced assets restore youthful hepatic metabolism and hold the potential to benefit diverse populations with liver disease and metabolic dysfunction.
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