Head of Clinical Development

<h1>Company info</h1> <p>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. We leverage functional genomics, pooled perturbation screening, and artificial intelligence systems to unravel the biology of aging and disease using experiments of unprecedented scale.</p> <h1>Description</h1> <p>NewLimit is recruiting a VP of Clinical Development to plan and execute 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.</p> <p>In this role, you will design and orchestrate clinical trials for some of the world’s first reprogramming medicines. You will serve as the company’s senior clinical scientist and as a member of our executive team.</p> <p>As part of your role, you will:</p> <ul> <li>Lead and orchestrate clinical development activities in collaboration with external partners.</li> <li>Create clinical trial protocols, author and own regulatory submissions, and contribute to regulatory interactions.</li> <li>Solve the inevitable logistical bottlenecks that block progress of our clinical studies.</li> <li>Serve as a member of NewLimit’s Executive Team and contribute to budgeting, goal setting, and technical review decisions.</li> <li>Build and run a clinical development team as we approach first-in-human dosing.</li> </ul> <h1>Requirements</h1> <ul> <li>M.D. or equivalent clinical training</li> <li>Experience planning and orchestrating first-in-human trials</li> <li>Experience with both US FDA and ex-US regulatory agencies (e.g. Australian TGA)</li> <li>Deep knowledge of Good Clinical Practices (GCP)</li> </ul> <h1>Nice to have</h1> <ul> <li>Experience in metabolic and liver disease therapeutic areas</li> <li>Experience leading a clinical development team across multiple therapeutic areas</li> <li>Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)</li> <li>Experience managing both early (Phase 1/2) and late-stage (Phase 3) clinical trials</li> </ul> <h1>Benefits</h1> <ul> <li>Health, dental, and vision insurance</li> <li>401(k) with company match</li> <li>Industry-leading paid time off (PTO) -- 20 days/year for all employees + holidays</li> <li>Paid parental leave</li> <li>Meals and snacks on-site</li> </ul> <p>Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Learn more at: <a href="https://www.newlimit.com/careers">https://www.newlimit.com/careers</a>&nbsp; &nbsp;</p>