Associate Director, Clinical Operations: People & Functional Leadership

Alto Neuroscience; United States; Hybride; USD 170 000 - 185 000; Plein temps

Résumé du poste

Alto Neuroscience seeks an Associate Director, Clinical Operations to lead a hands-on team (CTA, CRA, CTM, CPM) within an in-house trial model. You will drive site management, monitoring, and trial execution while developing staff and aligning resources with program needs.

Based in Mountain View, CA or Remote (US), you will collaborate with QA, Regulatory, and Development to ensure quality deliverables, budgeting, and capacity planning, in line with ICH-GCP and FDA/EMA standards.

Qualifications

• 10+ years hands-on clinical trial experience across CTA/CRA/CTM/CPM roles.
• 3+ years direct people management experience.
• Direct in-house site monitoring and trial execution experience.
• Strong knowledge of ICH-GCP, FDA/EMA regulations, and trial lifecycle.
• Proven ability to develop and coach Clinical Operations staff.

Responsabilités

• Direct, hands-on staff management, coaching, performance reviews, and development planning for 6–12 staff across CTA/CRA/CTM/CPM.
• Allocate workload and monitor capacity; manage staffing across studies and enrollments.
• Oversee site selection, initiation, monitoring, and close-out with in-house teams; avoid CRO delegation.
• Ensure adherence to ICH-GCP, SOPs, and regulatory requirements; escalate issues when needed.
• Partner with QA, Regulatory, Development, and other functions on program delivery and process improvements.

Connaissances

People management

Clinical trials

ICH-GCP

Regulatory knowledge

Leadership

Site monitoring

Budgeting

Cross-functional collab

Formation

Bachelor's degree in life sciences, nursing, or related field

Description du poste

Primary Role

The Associate Director, Clinical Operations provides line management and functional oversight for a team of clinical trial staff spanning Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are run in-house rather than outsourced to a CRO, so this role and its team hold direct, hands-on responsibility for site management, monitoring, and trial execution rather than oversight of a CRO’s delivery. This role is responsible for staff development, workload/resource allocation across assigned studies or programs, and ensuring consistent quality and process adherence across the team, while individual contributors retain day-to-day accountability for their assigned trials.

What you’ll do

People Management

• Directly manage, coach, and develop a team of 6–12 clinical staff across CTA, CRA, CTM, and CPM levels
• Conduct performance reviews, goal setting, and career development planning tailored to each direct report’s role and level
• Lead recruitment, onboarding, and training for new team members
• Identify training needs and coordinate role‑specific development (e.g., TMF management for CTAs, site monitoring for CRAs, vendor oversight for CTMs, cross‑functional leadership for CPMs)

Resource & Workload Management

• Allocate staff across studies based on trial phase, complexity, and enrollment status
• Monitor team capacity and elevate resourcing gaps or overallocation to the Director/Senior Director
• Support study budgeting and FTE planning in partnership with Clinical Operations leadership

Operational & Quality Oversight

• Ensure team members follow ICH‑GCP, SOPs, and applicable regulatory requirements across assigned trials
• Review and approve key study deliverables (monitoring plans, TMF completeness, site management plans) as appropriate to level
• Provide direct, hands‑on guidance on site selection, initiation, monitoring, and close‑out — activities performed in‑house by the team’s CRAs and CTMs rather than a CRO
• Serve as an escalation point for site‑level or protocol‑execution issues that direct reports cannot resolve independently
• Partner with QA on audit/inspection readiness and CAPA follow‑up for the team’s studies

Cross‑Functional Collaboration

• Represent Clinical Operations staffing and capacity needs in program‑level planning meetings
• Partner with Clinical Development, Regulatory, Biostatistics, and Data Management leads to align trial execution with program timelines
• Provide input to senior leadership on process improvements and standardization across trials

Location

Mountain View, CA or Remote (US)

Salary Range

$170,000 - $185,000

*depending on qualifications and experience level

Travel Required

Travel required (approximately 25–30%)

Qualifications

Required Skills/Abilities:

• 10+ years of hands‑on clinical trial experience across multiple Clinical Operations roles, including CTA, CRA, CTM, and/or CPM experience.
• 3+ years of direct people management experience.
• Direct experience with site monitoring, site management, and clinical trial execution in an in‑house operating model.
• Strong working knowledge of ICH‑GCP, FDA/EMA regulations, and the clinical trial lifecycle.
• Demonstrated experience managing and developing Clinical Operations staff across varying levels of seniority.
• Strong organizational, communication, and problem‑solving skills, with the ability to manage competing priorities across multiple studies.
• Experience with inspection readiness, audits, and CAPA follow‑up.
• Experience supporting multiple clinical programs or studies simultaneously.

Bonus Skills/Abilities:

• Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment.

Supervisory Responsibilities

• Directly manages, coaches, and develops Clinical Operations staff across CTA, CRA, CTM, and CPM levels, including performance management, goal setting, career development, and workload allocation.

Education and Experience

• Bachelor’s degree in life sciences, nursing, or related field (advanced degree a plus)

Physical Requirements

• Required to sit for prolonged periods of time.
• Ability to travel domestically and internationally.
• While performing the duties of this job, the noise level in the work environment is usually

Alto Neuroscience is an equal‑opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.