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Clinical Development, Program Lead

Alto Neuroscience · Mountain View, CA · On-site

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About Alto Neuroscience

About Alto Neuroscience, Inc. At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. Backed by Stanford.

About the role

We are seeking an experienced Clinical Development , Program Lead to oversee one of Alto’s advanced clinical programs. This role will have end-to-end accountability for leading the strategy, design, and execution of this clinical development program, including Phase 1 through Phase 3 trials, long-term safety studies, and preparation for regulatory submissions.

What they're looking for

  • M.D., Ph.D., or equivalent advanced degree in a relevant discipline
  • 5+ years of experience in clinical development within the biopharma industry, including direct responsibility for Phase 1-3 study execution
  • Proven track record in designing and executing clinical programs in psychiatry or other relevant indications
  • Prior involvement in FDA or EMA meetings supporting clinical development
  • Deep understanding of clinical trial operations, GCP, and regulatory expectations for pivotal programs
  • Proven ability to synthesize clinical and operational perspectives into decisive program leadership
More about this role

Primary Role

We are seeking an experienced Clinical Development , Program Lead to oversee one of Alto’s advanced clinical programs. This role will have end-to-end accountability for leading the strategy, design, and execution of this clinical development program, including Phase 1 through Phase 3 trials, long-term safety studies, and preparation for regulatory submissions.

The Program Lead will be responsible for refining clinical trial designs, overall long-term development strategy, and medical/scientific oversight of clinical studies. They will work closely with clinical operations on execution, data integrity, and regulatory readiness. This is a highly visible leadership role that bridges scientific, clinical, operational, and commercial disciplines to move Alto compounds forward including to registration and commercialization.

What you'll do

Program Leadership

  • Serve as the overall program lead, accountable for end-to-end planning, execution, and delivery of key milestones of clinical studies through NDA submission.
  • Partner closely with Program Management to drive alignment and execution across the cross-functional program team, including development and maintenance of...

Read the full posting on Alto Neuroscience's site ↗

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