Associate Director, Clinical Operations

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 Associate Director, Clinical Operations will be leading the planning, coordinating and execution of one or more global clinical trials in accordance with project milestones, within budget and with high quality in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and SOPs.

The Associate Director will be responsible for leading and implementing the study execution / strategy for assigned trials, managing, and identifying risks and implementing risk mitigation strategies with a 3-year horizon.

Key Responsibilities

• Leads clinical operations activities for assigned programs ensuring compliance with Good Clinical Practices (GCP), ICH and applicable regulations.
• Responsible for the oversight of global studies providing direction and oversight to Clinical Trial Managers and CRO Study Teams. May be the lead for Study Execution to ensure protocol and regulatory compliance.
• Is a member of the Clinical Development Team, contributing to overall Clinical Development planning and strategies.
• Responsible for leading CRO selection and management, investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports for assigned trials.
• Develops project timelines, to meet department and corporate goals for timely initiation and completion of clinical studies.
• Identify study risks and develop and implement mitigation strategies for clinical studies.
• Oversee KPI tracking CRO for assigned trials, e.g., tracking of clinical reviews, data query resolution for therapeutic indication.
• Provide senior management with timely updates on progress and changes in scope and schedule.
• Coordinate and responsible for oversight of investigator meetings slides and content.
• Coordinate Site Outreach and enrollment efforts for assigned programs.
• Partner with and ensure regular and effective communication with key stakeholders including Regulatory Affairs (RA), Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, Finance, and others, as necessary.
• Contribute to clinical study reports, sections for Investigator's Brochures, protocols and other regulatory documents in conjunction with Medical Writing.
• Ensure Clinical Trial Master File for assigned trials are being updated by Alumis and CRO, and are inspection ready at all times.
• Assess feasibility of enrollment across different indications by providing assessment of timelines/rate of patient availability.
• Provide input and may co-lead the development of clinical documents (protocols, clinical trials report, investigator brochures, etc.) and will lead the development of all study related plans necessary for trial conduct.

Professional Experience /Qualifications:

• Keeps abreast of current industry practices and standards for outsourcing and GCP system requirements.
• Self-directed and collaborative while building strong working relationships across multiple departments to finalize documents, including in high-pressure situations.
• Demonstrated knowledge of clinical regulatory documentation requirements (familiar with GCP, CTD, FDA, and ICH requirements).
• Highly skilled communicator, who builds and maintains strong relationships, internally and externally.
• Excellent writing and editing skills who writes clearly, concisely, and effectively with an aptitude for compilation, analysis, and presentation of data.
• Is a highly effective influencer to drive partner relationships and deliverables.
• Is highly credible, building compelling data driven cases to business partners.
• Able to problem solve and use good judgement.
• Detail oriented.
• Developing or skilled people manager, responsible for growth, development and promotion of direct reports.
• Subject to COVID-related conditions and restrictions, must be willing to travel domestically and internationally.

Preferred Education:

B.A. or advanced degree in biological science or life sciences discipline.

Preferred Experience:

At least 10 years’ experience in clinical operations with 3 years’ experience leading and managing the execution of global clinical trials from start-up through clinical study report generation. Experience in both early and late phase of development preferred.

Preferred Computer Skills:

Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint and Microsoft Project.

Alumis Values:

• We Elevate
• We Challenge
• We Nurture

This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.

Alumis Inc. is an equal opportunity employer.

If you are hired, we will require you to prove that you have received all CDC-recommended doses of the COVID-19 vaccine or have a valid religious or medical reason not to be vaccinated.

Recommended Skills

• Attention To Detail
• Biostatistics
• Clinical Research
• Clinical Study Reports
• Clinical Works
• Communication