Associate Director, Clinical Operations
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.
The Associate Director of Clinical Operations plays a pivotal role in overseeing the planning, coordination, and execution of global clinical trials. This position ensures adherence to project milestones, maintains fiscal responsibility, and upholds quality standards in compliance with ICH/GCP guidelines, regulatory mandates, and internal SOPs. The role involves developing and implementing study execution strategies and providing leadership to direct reports.
The Associate Director fosters a supportive environment, encouraging authenticity and open communication. Committed to science and thoughtful risk-taking, the Associate Director collaborates across teams to find innovative solutions to technical and business challenges. They proactively identify risks and implement mitigation strategies, driving success in clinical operations with a strategic vision and teamwork.
Key Responsibilities:
Oversee global studies, providing direction to Clinical Trial Managers and CRO Study Teams.
Contribute to Clinical Development planning and strategies.
Lead CRO selection and management, oversee investigator recruitment and selection, study start-up, enrollment, data collection, and drug projections.
Develop project timelines to meet departmental and corporate goals.
Identify and implement mitigation strategies for study risks.
Track KPIs for assigned trials, including clinical reviews and data query resolution.
Provide senior management with timely updates on progress and changes in scope.
Oversee the preparation and content of investigator meetings.
Coordinate site outreach and enrollment efforts.
Communicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and Finance.
Contribute to clinical study reports, Investigator's Brochures, protocols, and other regulatory documents.
Ensure the Clinical Trial Master File is updated and inspection-ready.
Assess enrollment feasibility across different indications.
Lead or co-lead the development of clinical documents and study-related plans.
Professional Experience / Qualifications:
Up-to-date knowledge of industry practices, outsourcing, and GCP system requirements.
Strong collaborative skills and the ability to build relationships across departments.
Documented training in FDA Regulations, GCP, and ICH guidelines.
Excellent communication and writing skills.
Effective influencer and relationship builder.
Problem-solving abilities and good judgment.
Detail-oriented.
Experience managing and developing direct reports.
Willingness to travel domestically and internationally (10-15%).
Regulatory authority inspection experience is a plus.
Preferred Education:
B.A. or advanced degree in biological sciences or a related discipline.
Preferred Experience:
At least 10 years of experience in clinical operations within biotech, pharmaceutical, or CRO environments, with 5 years of experience managing global clinical trials. Experience in early and late phases of development and immune-mediated diseases.
Preferred Computer Skills:
Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.
Alumis Values:
We Elevate
We Challenge
We 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 $205,000 USD to $215,000 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.
-
Associate Director/Director
2 months ago
South San Francisco, California, United States Annexon, Inc. Full timeWork LocationCorporate Headquarters (South San Francisco, CA) Position SummaryThis position reports into the Vice President / Executive Director of Global Clinical Operations. The Associate Director/Director - Clinical Operations (Ophthalmology) will contribute to the development and implementation of clinical studies. Responsibilities include providing...
-
Associate Director, Clinical Operations
2 months ago
San Francisco, California, United States Nurix Therapeutics Full timeJob Summary:Nurix Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to join the Clinical Operations team. The successful candidate will be a core member of the Clinical Development Team and will contribute to development and implementation of the Clinical Development Plan (CDP), Product Strategy, Therapeutic Area Strategy, Clinical...
-
Clinical Trial Operations Associate
3 days ago
South San Francisco, California, United States Allogene Therapeutics Full timeJob OverviewAbout Allogene:Allogene Therapeutics, located in South San Francisco, is at the forefront of biotechnology, specializing in the innovative development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) therapies aimed at treating cancer and autoimmune disorders. Our experienced leadership team is dedicated to creating a pipeline of...
-
Associate Director
1 month ago
San Francisco, California, United States Nurix Therapeutics Full timeJob Purpose: The Associate Director/Director of Clinical Data Management (CDM) will be responsible for the delivery and integrity of clinical data across Nurix's multiple studies/programs. This role may also support process development and improvement in building clinical data management infrastructure. The ideal candidate will ensure adherence to industry...
-
San Mateo, California, United States BeiGene Full timeGeneral Description: BeiGene is a rapidly growing next-generation biotechnology company with a focus on developing affordable medicines to treat cancer while reducing costs and increasing global access to those medicines. Global Clinical Operations at BeiGene is a dynamic and growing organization leading a team of more than 1,000 associates in 40+ countries...
-
San Francisco, California, United States Nurix Therapeutics Full timeRole Overview:Reporting to the VP, Head of Medical Affairs, the Associate Director, Director, Medical Affairs Operations will be an integral part of the Medical Affairs team, managing systems implementation, project management, and execution of key projects across Nurix' pipeline and therapeutic areas. The ideal candidate will bring a robust background in...
-
Senior Director of Clinical Quality Assurance
1 month ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis 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. Alumis is hiring a Clinical Quality Assurance...
-
Senior Clinical Oversight Specialist
3 days ago
San Diego, California, United States Clinical Dynamix Full timeThe Senior Clinical Oversight Specialist plays a crucial role in the clinical research landscape, serving as the primary liaison for clinical research sites. This remote position involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...
-
Senior Clinical Oversight Specialist
3 days ago
San Diego, California, United States Clinical Dynamix Full timeThe Senior Clinical Oversight Specialist plays a pivotal role in the remote field, acting as the primary liaison for clinical research sites throughout the study lifecycle. This position involves conducting essential qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the...
-
Senior Clinical Oversight Specialist
3 days ago
San Diego, California, United States Clinical Dynamix Full timeThe Senior Clinical Oversight Specialist is a remote, field-based position responsible for offering support to clinical research sites as the primary liaison for the study. This role involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...
-
Manager of Clinical Operations
1 month ago
San Francisco, California, United States On Target Executive Search Full timeManager of Clinical Operations Fairland, CA About Our ClientOur Client s Mission is to successfully restore our patient s quality of life through superior clinical care while creating an environment that inspires our team to develop and achieve their professional aspirations. Our Vision is to BE the BEST rehab provider in the communities we serve. Job...
-
Clinical Operations Research Associate
3 days ago
San Diego, California, United States Jobot Full timeJoin Our Innovative Team with Attractive Compensation and Growth OpportunitiesWe are a forward-thinking biotech organization focused on pioneering research and clinical advancements in oncology. Our recent achievements in securing FDA approvals reflect our dedication to innovation in cancer treatment solutions.Why Consider Joining Us?Attractive Salary...
-
Senior Clinical Trial Manager
1 month ago
South San Francisco, California, United States Annexon, Inc. Full timePosition SummaryThe Senior Clinical Trial Manager / Associate Director, Clinical Operations (Ophthalmology) is responsible for the operational management, oversight and execution of one or more clinical trials including CROs, vendors, and consultants as needed for the conduct of clinical studies. This individual will report to the Executive Director,...
-
South San Francisco, California, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
South San Francisco, California, United States Surf Search Full timeDirector/Senior Director, Regulatory Medical Writing (Remote).Position Overview: The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line reporting to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write...
-
Associate Director, Statistics
4 weeks ago
South San Francisco, California, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
Head of Clinical Quality Assurance
3 days ago
South San Francisco, California, United States GQR Full timePosition: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role focused on ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific guidelines), ICH standards,...
-
Associate Director of Finance
2 weeks ago
San Francisco, California, United States Sage Hospitality Group Full timeWhy us? Join the Sage Hospitality team today at Hotel Zelos as our new Associate Director of Finance Work Where You Belong Hotel Zelos, a futuristic, fashion-forward oasis that fuses sleek lines and sophisticated style. Crisp, cool, and clean design and stylish onsite dining create a craveable retreat in the heart of the city. Indulge your vices in Hotel...
-
Director, Governance Operations
2 months ago
San Francisco, California, United States Pacific Gas and Electric Company Full timeRequisition ID # Job Category: Business Operations / Strategy Job Level: Director/ChiefBusiness Unit: Gen Counsel, Ethics, Risk & ComplianceWork Type: HybridJob Location: OaklandPosition SummaryLeads a diverse team for Corporate Secretary operations. This includes a variety of shareholder, corporate governance and legal matters and requires effective...
-
Associate Director, CMC Analytical Development
2 months ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis 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 small molecule CMC team is seeking a highly...