Director, Clinical Operations - Initial Therapeutics, Inc.

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.

The Director of Clinical Operations at Alumis plays a vital role in guiding the planning, execution, and oversight of assigned clinical trials. As a collaborative leader, you will ensure projects are executed efficiently, within budget, and to the highest regulatory and quality standards. This role requires a balance of strategic insight and hands-on management, with a focus on supporting cross-functional teams to achieve both departmental and corporate goals.

Embodying Alumis’s core values, you will promote an environment that encourages open communication and innovation, continually seeking to enhance the efficiency and quality of our clinical trial operations. Reporting to the Senior Director of Clinical Operations, you will be instrumental in driving operational excellence and fostering a culture of integrity and scientific rigor.

Essential Responsibilities:

• Oversee the planning, execution, and completion of assigned clinical trials to ensure adherence to timelines, budgets, and quality standards. Proactively identify risks and develop mitigation strategies to achieve study milestones.
• Collaborate with cross-functional teams to select, negotiate, and manage contracts with CROs and other vendors. Ensure vendor compliance with ICH/GCP, regulatory standards, and Alumis SOPs.
• Direct the development and management of essential study documents, including protocols, ICFs, study manuals, and clinical study reports. Provide operational oversight to ensure efficient site activation, enrollment, and data collection.
• Develop and manage clinical operations budgets, allocate resources to support trial objectives, and adjust project scope and resources as needed.
• Work closely with Clinical Development, Biostatistics, Data Management, and Regulatory Affairs to align study operations with corporate goals and regulatory requirements.
• Lead clinical operations to ensure compliance with all regulatory requirements. Respond to site, internal, and regulatory agency audits as necessary, working with quality and compliance teams to address findings.
• Mentor and lead a team of Clinical Trial Managers, fostering a culture of high performance and accountability. Develop direct reports and support career growth within Clinical Operations.
• Provide regular, comprehensive updates on trial status, challenges, and resource needs to senior leadership and executive management.

Professional Experience / Qualifications:

• Proven expertise in managing global early- and late-phase clinical trials, with hands-on experience in CRO oversight and vendor management.
• Strong knowledge of GCP, ICH, and regulatory guidelines applicable to clinical trial conduct.
• Experience managing departmental budgets and financial forecasting for clinical programs.
• Demonstrated strategic and critical thinking with the ability to navigate complex clinical operations landscapes.
• Strong interpersonal and communication skills, with the ability to influence cross-functional teams and lead through ambiguity.
• High level of cultural agility and ability to work effectively across diverse teams and global regions.
• Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.

Education Requirement:

Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.

Experience Requirement:

A minimum of 12 years of Clinical Operations experience, including 8+ years in a program management role within the biotech or pharmaceutical industry and 2+ years in the field of autoimmune disease.

The salary range for this position is $235,000 USD to $250,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.* At this time we are not considering remote applicants.

Alumis Inc. is an equal opportunity employer.

Benefits:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.

*Alumis Lab personnel are generally onsite 4-5 days/week