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Senior Clinical Trial Manager, ONWARD Program
2 months ago
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.
We are looking for an experienced Senior Clinical Trial Manager to join our ONWARD study team. ONWARD is a global Phase 3 trial aimed at evaluating the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis (PsO). We recognize the unmet need for an oral therapy that is safe, easy to use for both patients and physicians, and capable of delivering biologic-level efficacy for those with PsO.
As a Senior Clinical Trial Manager at Alumis, you will be responsible for executing clinical studies to the highest quality standards. You will ensure the integrity of clinical data, adhere to schedules, and manage budgets for Phase I-IV clinical trials by overseeing and managing vendors and contractors. By embracing our core values—We Elevate, We Challenge, We Nurture—you will play a pivotal role in driving the success of our clinical programs and advancing innovative treatments.
Essential Responsibilities
- Manage all day-to-day execution of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.). May sit on the Clinical Development Team (if functioning as a study lead).
- Oversee aspects of clinical trials from start-up through completion
- Facilitate the development and review of protocols, informed consent documents, and clinical sections of Investigator Brochures.
- Conduct vendor feasibility, capabilities, selection, management, and oversight activities.
- Ensure on-time execution and conduct of clinical studies, including tracking the development of budget items, milestones, and timelines.
- Coordinate cross-functional study team members (e.g. biostats, contracts, quality assurance, regulatory, clinical pharmacology, data management, medical monitors) and stakeholders (study vendors) to ensure initiation and execution of clinical study deliverables within approved budget and timelines.
- Manage risk and mitigation, prioritizing competing tasks and issues to ensure program/study objectives are successfully accomplished.
- Contribute to or lead the systems set-up/management including EDC, IRT, Central Laboratories, specialty services (ePRO, eDiary, etc.).
- Ensure data integrity through routine data reviews, query resolution, and consistency checks.
- Critically assess data to detect trends, outliers, and responsively direct resources and attention to correct problems early.
- Track and communicate program/study progress to Senior Management, creating and updating detailed dashboards, trackers and presentation materials.
- Ensure timely submission of documents to TMF and provide oversight to ensure TMF completeness and quality.
Professional Experience / Qualifications:
- Demonstrated experience in initiating and managing Phase I-IV clinical trials.
- Proven experience in managing CROs and selecting vendors.
- Willingness to be hands-on and perform tasks within tight turnaround times.
- Excellent interpersonal and communication skills with developing leadership attributes.
- Success working in a matrixed environment.
- Experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).
- Expertise in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase I-IV).
- Ability to multitask in a fast-paced environment.
- Strong ability to build cooperative relationships with coworkers.
- Capable of authoring complex documentation with minimal supervision.
- High degree of attention to detail.
- Comfortable with travel and able to travel up to 25% of the time as needed.
Preferred Education
B.S. or advanced degree in biological sciences or a related discipline.
Preferred Experience
At least 8 years of relevant experience, including previous experience managing clinical trials at a biopharma company or a Contract Research Organization (CRO).
Preferred Computer Skills
Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.
Alumis Values
- Elevate
- Challenge
- Nurture
This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.
The salary range for this position is $ 185,000 USD to $195,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer.
