Sr. Director Clinical Development​/Program Leader

Career Opportunities with Alto Neuroscience, Inc.

Careers At Alto Neuroscience, Inc.

Current job opportunities are posted here as they become available.

We are seeking an experienced 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

• 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.

Clinical & Medical Leadership

• 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 authorities 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.

Execution of Clinical Studies

• 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.

Regulatory & Cross-Functional Interface

• 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.

Team & Culture

• 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 nimble, high-performing clinical development team in a growing biotech environment.

LOCATION

Remote or On-site (Mountain View, CA)

SALARY RANGE

$140,000 - $160,000

Compensation includes a base salary, an annual target bonus, and an equity grant.

QUALIFICATIONS

Required Skills:

• M.D., Ph.D., or equivalent advanced degree in a relevant…