Alto Neuroscience · 18 hours ago
Sr. Director Clinical Development/Program Leader
Mountain View, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$140K/yr - $160K/yr
5+ years expAlto Neuroscience is a company focused on advancing precision psychiatry and improving treatments for mental health disorders. They are seeking an experienced Program Lead to oversee advanced clinical programs, ensuring the strategy, design, and execution of clinical development from Phase 1 through Phase 3 trials and regulatory submissions.
Artificial Intelligence (AI)BiopharmaBiotechnologyNeurosciencePrecision Medicine
Responsibilities
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 integrated project plans, timelines, and budgets; proactive identification of risks; and implementation of mitigation strategies
Ensure operational excellence and quality across all program activities, including oversight of external vendors and partners
Collaborate with the CMO and senior leadership to align development activities with Alto’s corporate objectives and portfolio priorities
Represent the program at internal governance forums and, as appropriate, in interactions with partners or external stakeholders
Provide clinical leadership and oversight for the program, ensuring scientific rigor, patient safety, and data integrity. If an MD, provide medical oversight. If not an MD, work closely with the designated medical monitor
Oversee clinical review of safety, efficacy, and emerging biomarker data
Lead study review committees and participate in the interpretation of interim and final study results
Partner with with the CMO and cross-functional experts to refine study designs and long-term safety strategies
Support interactions with health authority such as FDA and EMA, including preparation of briefing packages and regulatory submissions
Engage externally with clinical investigators, key opinion leaders, and advisory boards to ensure study alignment with medical and scientific standards
Collaborate closely with Clinical Operations, Data Management, and Data Science to ensure high-quality trial conduct, timely database locks, and accurate data reporting
Ensure compliance to GCP, protocol requirements, and regulatory standards across all study sites
Drive internal readiness and alignment for key study milestones and data readouts
Provide clinical leadership during analysis, interpretation, and communication of results, including publications, scientific meetings, and regulatory submissions
Lead or contribute to drafting and review of key regulatory documents, including study reports, briefing packages, and NDA components
Partner with Regulatory Affairs, Clinical Operations, and CMC to ensure readiness for pivotal and registration phases
Support external scientific communication efforts through investigator meetings, advisory boards, and KOL engagement
Provide mentorship and clinical leadership to other team members
Champion Alto’s culture of accountability, collaboration, and patient-focused innovation
Operate as a hands-on leader within a a nimble, high-performing clinical development team in a growing biotech environment
Qualification
Required
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
Exceptional communication, collaboration, and leadership skills
Comfort working in a fast-paced, entrepreneurial environment requiring both strategic and hands-on engagement
Preferred
Experience leading psychiatric or neuroscience development programs
Demonstrated success overseeing late-stage trials and contributing to regulatory submissions (e.g., NDA, sNDA, MAA)
Exposure to or interest in biomarker-driven development, including neurophysiologic or digital biomarkers
Benefits
Compensation includes a base salary, an annual target bonus, and an equity grant.
Company
Alto Neuroscience
Alto Neuroscience is a clinical-stage biopharmaceutical company that creates precision medicines through its AI-driven biomarker platform.
51-200 employees
H1B Sponsorship
Alto Neuroscience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2022 (4)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$300.96MKey Investors
Perceptive AdvisorsWellcome TrustInVivium Capital
2025-10-20Post Ipo Equity· $50M
2024-07-25Grant· $11.7M
2024-02-02IPO
Leadership Team
Amit Etkin
Founder and CEO
Wei Wu
Co-Founder
Recent News
2026-01-16
Company data provided by crunchbase