Autonomybio

Autonomybio

VP, Clinical Development / CMO / CDO

San Francisco Office · Vp

Sponsorship not specified$20k-$30kDetected 474 days ago
FDA RegulatoryLeadershipProblem Solving

About the role

  • This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
  • Read more in our Candidate Guide https://strong-transport-ceb.notion.site/Candidate-Guide-1a01fc245011803fbc7becb61ea1d52c?pvs=4.
  • SUCCESS MEASURES WITHIN THE FIRST 3-6 MONTHS, YOU WILL HAVE: 1.

Responsibilities

  • Design & Own the Clinical Roadmap: Develop and own the integrated clinical plan for our lead program and broader pipeline.
  • Regulatory Coordination: Work closely with our regulatory lead to strategize and execute a regulatory strategy for aging therapies. Lead all major regulatory interactions - briefing packages, meeting prep, post-meeting strategies.
  • Develop and Validate Novel Aging Endpoints: Collaborate with scientific and regulatory stakeholders to define, validate, and advocate for new clinical endpoints that capture aging-related healthspan improvements.
  • Innovate in Trial Design: Incorporate decentralized trials, adaptive protocols, AI-driven endpoints, and real-world data to cut costs, accelerate timelines, and maximize impact.
  • Build the Team: Hire, mentor, and inspire a world-class clinical and regulatory team, with no ego and a high bar for performance, creativity, and mission alignment.
  • Drive Quality and Compliance: Develop and institutionalize a biotech-focused QMS.
  • Established Integration with AI/Data Leads to ensure Phase 1 readouts can be tracked in real-time, especially for unique combination PK/PD data.
  • Navigated Key FDA Milestones such that the IND for AUTO-1 is approved on schedule; shaped a feasible Phase 3 design aligned with FDA insights on aging endpoints.
  • Executed a Timely Phase 1 Readout that validates combination safety data, enabling immediate pivot or progression to Phase 3.
  • Expanded the Clinical Organization to manage parallel pipeline programs, hiring additional senior managers in clinical development, trial ops, and regulatory.

Requirements

  • Proven ability to "run the show" for clinical development, orchestrating cross-functional teams with autonomy and accountability.
  • familiarity with unique geriatric endpoints such as intrinsic capacity or multi-factor biomarkers.
  • Experience handling 5-7-year follow-up trials or outcomes-based studies with novel endpoints.

Nice to have

  • 3+ Years of Senior Clinical Development Experience in biotech, pharma, or a related field, ideally with at least 2 years in a startup environment.
  • Experience with Long-Duration Studies: Experience handling 5-7-year follow-up trials or outcomes-based studies with novel endpoints.
  • Global Regulatory Acumen: Experience aligning clinical endpoints across multiple regulatory bodies and geographies.
  • Advanced Degree (MD or Equivalent) in a related Life Sciences field preferred.
  • Experience in Therapeutic Areas Without Established Endpoints: Comfortable designing and validating new clinical endpoints where regulatory precedents are limited or evolving.
  • Experience in the therapeutic areas: neurodegeneration, cardiometabolism, rare diseases or vaccines.

Compensation

  • $20k-$30k

Company info

  • We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases. Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health. This is a new paradigm focused on keeping healthy people healthy as opposed to treating individual diseases after they occur.
  • We are an early-stage biotech company developing drugs with the goal of reducing multi-morbidity and earning an indication for aging, as opposed to the treatment of specific diseases.
  • Our ultimate mission is to establish aging as a therapeutic area and empower humans with more time with loved ones and autonomy over their health.
  • Hire, mentor, and inspire a world-class clinical and regulatory team, with no ego and a high bar for performance, creativity, and mission alignment.
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