Senior Director, Clinical Operations
3 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 Senior Director of Clinical Operations is a pivotal role within our organization, responsible for driving the management, oversight, and hands-on execution of Alumis’s clinical programs. Serving as both a strategist and implementer, this dynamic leader ensures projects are completed on time, within budget, and meet all regulatory and corporate quality standards. As a key functional leader and subject matter expert, you will collaborate with other functional leads to achieve departmental and corporate objectives.
As a champion of Alumis’s core values, you will challenge existing processes and nurture a supportive environment where team members can show up authentically and speak openly. Leveraging your extensive industry knowledge and experience, you will proactively enhance the efficiency, effectiveness, and quality of Alumis’s clinical trial activities. Reporting directly to the Senior Vice President of Development Operations, you will embrace a commitment to following the science and taking bold, thoughtful risks to find innovative solutions to challenging technical and business problems.
Essential Responsibilities:
- Manage and implement clinical operational functions, allocating and directing internal resources and effectively outsourcing when necessary to achieve project goals in a timely manner.Actively lead and participate in the development of critical study documents, such as protocols, ICFs, study manuals, investigator brochures, and clinical study reports.Identify outsourcing needs and oversee the selection, management, and performance of CROs, vendors, and external consultants.Develop and maintain strong, positive collaborations with internal and external functional leaders.Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices.Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials.
- Provide accurate, current updates to executive management related to the status of clinical trials (e.g., monthly or as needed).
- Lead responses to audits as required, including site, internal file and process, and regulatory agency audits.
- Be accountable for budgeting, forecasting, and overall management of clinical budgets.
- Lead constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones.
- Strategically plan and execute clinical trials, ensuring they are conducted within timelines, budget, and regulatory and corporate quality standards.
Professional Experience / Qualifications:
- Extensive experience in setting up and managing domestic and international early and late-phase clinical trials, either directly or through CRO/vendor management.
- Proven ability to manage multiple projects and priorities.
- Strong working knowledge of GCP/ICH guidelines.
- Experience in developing and managing departmental and study budgets and timelines.
- Excellent interpersonal skills with a demonstrated ability to effectively work with internal and external cross-functional groups.
- Extensive knowledge of drug development functions relevant to clinical trial conduct (e.g., data management, biostatistics, pharmacovigilance, CMC/supply chain management, etc.).
- Demonstrated ability to collaborate effectively in cross-functional teams, to lead and develop a high-performing team and to mentor team members at all levels.
- Excellent written, communication, and interpersonal skills, with demonstrated cultural agility.
- Embody and champion Alumis Biotech’s values: to nurture, to elevate, and to challenge.
Preferred Education:
A bachelor’s degree or higher in a relevant field, preferably related to biological or life science. Higher/professional degree a plus.
Preferred Experience:
At least 15 years of Clinical Operations experience, including 10+ years in a management role and 5+ years in the field of autoimmune disease.
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 $270,000 USD to $285,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer.
-
Senior Director of Clinical Operations
6 days ago
South San Francisco, California, United States Frontier Medicines Full timeJob Title: Senior Director, Clinical OperationsFrontier Medicines is seeking a highly motivated individual to fill the position of Senior Director, Clinical Operations to help develop the early project portfolio. The team is focused on the discovery of new medicines to treat cancers and other serious disorders.Key Responsibilities:Partner with team leaders...
-
Senior Director of Clinical Operations
6 days ago
South San Francisco, California, United States Alumis Full timeJob Title: Senior Director, Clinical OperationsAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.Job SummaryWe are seeking a highly experienced Senior Director of Clinical Operations to drive the management, oversight,...
-
Senior Resident Care Director
2 weeks ago
San Francisco, California, United States Sunrise Senior Living Full timeAbout the RoleSunrise Senior Living is seeking a highly skilled and experienced Senior Resident Care Director to lead our clinical operations team. As a key member of our leadership team, you will be responsible for providing strategic direction and oversight of our resident care programs, ensuring the highest level of quality and service delivery.Key...
-
Senior Resident Care Director
2 weeks ago
San Francisco, California, United States Sunrise Senior Living Full timeSenior Resident Care Director Job SummaryAt Sunrise Senior Living, we are committed to providing high-quality care and services to our residents. As a Senior Resident Care Director, you will play a critical role in leading our clinical team and ensuring the health and well-being of our residents.Key Responsibilities:Manage all clinical programs, quality...
-
Senior Resident Care Director
3 weeks ago
San Francisco, California, United States Sunrise Senior Living Full timeAbout the Role:Sunrise Senior Living is seeking a highly skilled and experienced Senior Resident Care Director to lead our clinical operations team. As a key member of our leadership team, you will be responsible for providing overall leadership and management of the health and well-being of our residents.Key Responsibilities:Manage all clinical programs,...
-
Senior Director, Clinical Operations
4 weeks ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: 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 Senior...
-
Senior Director of Clinical Operations
3 days ago
South San Francisco, California, United States Alumis Full timeJob OverviewAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. As a Senior Director of Clinical Operations, you will play a pivotal role in driving the management, oversight, and execution of our clinical programs.This dynamic leader will ensure projects are completed on time, within budget,...
-
Clinical Operations Director
2 days ago
South San Francisco, California, United States Meet Full timeJob Title: Associate Director Clinical OperationsMeet our client, a leading company in the pharmaceutical industry, seeking an experienced Associate Director of Clinical Operations to lead their global Phase 3 clinical trials. This role requires a strategic leader who excels in operational excellence and team collaboration to ensure the successful execution...
-
Senior Director, Clinical Operations Lead
2 weeks ago
South San Francisco, California, United States Frontier Medicines Full timeJob Title: Senior Director, Clinical OperationsFrontier Medicines is seeking a highly skilled and experienced Senior Director, Clinical Operations to join our team. As a key member of our clinical operations team, you will play a critical role in advancing our oncology projects through discovery and into clinical development.Key Responsibilities:Partner with...
-
South San Francisco, California, United States Clinical Dynamix Full timeJob Title: Associate Director, Global Monitoring OperationsAt Clinical Dynamix, we are seeking an experienced Associate Director to lead our Global Monitoring Operations team. The successful candidate will be responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies.Key Responsibilities:Develop and implement...
-
South San Francisco, United States Clinical Dynamix Full timeTitle: Associate Director, Global Monitoring Operations Reports to: Sr. Director, Global Monitoring Operations Location: Remote-based (US) Position Overview: The Associate Director (AD), Global Monitoring Operations is responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies at Company. The AD, Global Monitoring...
-
Senior Resident Care Director
6 days ago
San Francisco, California, United States Sunrise Senior Living Full timeJob Title: Senior Resident Care DirectorSunrise Senior Living is seeking a highly skilled and compassionate Senior Resident Care Director to join our team. As a key member of our leadership team, you will be responsible for providing exceptional care and services to our residents.Responsibilities:Manage all clinical programs, quality assurance, and...
-
Senior Resident Care Director
2 days ago
San Francisco, California, United States Sunrise Senior Living Full timeSenior Resident Care Director Job DescriptionSunrise Senior Living is seeking a highly skilled and compassionate Senior Resident Care Director to join our team. As a key member of our leadership team, you will be responsible for providing exceptional care and services to our residents, while also overseeing the daily operations of our community.Key...
-
Senior Clinical Director
2 days ago
San Francisco, California, United States Early Autism Services Full timeSenior Clinical Director OpportunityEarly Autism Services is seeking a seasoned Senior Clinical Director to lead our clinical and operational initiatives in the Leeds, Birmingham, and Montgomery, AL areas. As a key member of our leadership team, you will provide clinical and operational guidance and supervision to our team of Board Certified Behavior...
-
Associate Director, Clinical Operations
3 months ago
South San Francisco, 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. The Associate Director of Clinical...
-
Senior Resident Care Director
4 days ago
San Francisco, California, United States Sunrise Senior Living Full timeOverviewSunrise Senior Living is a leading provider of senior care services, dedicated to delivering high-quality care and services to our residents. We are seeking a highly skilled and experienced Senior Resident Care Director to join our team.ResponsibilitiesManage all clinical programs, quality assurance, and regulatory complianceAssist in the training...
-
Senior Resident Care Director
2 weeks ago
San Francisco, California, United States Sunrise Senior Living Full timeSenior Resident Care Director Job SummarySunrise Senior Living is seeking a highly skilled and compassionate Senior Resident Care Director to lead our clinical programs and ensure the highest quality of care for our residents.Key Responsibilities:Manage and oversee all clinical programs, quality assurance, and regulatory complianceAssist in the training and...
-
Clinical Operations Director
6 days ago
South San Francisco, California, United States Structure Therapeutics Full timeJob Title: Director, Clinical Operations Process Improvement and Vendor OversightStructure Therapeutics is seeking a highly experienced Director, Clinical Operations Process Improvement and Vendor Oversight to join our team. As a key member of our clinical operations department, you will be responsible for ensuring adherence to regulatory requirements,...
-
Senior Resident Care Director
2 weeks ago
San Francisco, California, United States Sunrise Senior Living Full timeSenior Resident Care Director Job SummarySunrise Senior Living is seeking a highly skilled and compassionate Senior Resident Care Director to lead our clinical programs and ensure the highest quality of care for our residents.Key Responsibilities:Manage all clinical programs, quality assurance, and regulatory complianceAssist in the training and onboarding...
-
Clinical Operations Director
1 week ago
San Antonio, Texas, United States Worldwide Clinical Trials Full timeDirector of Clinical Operations Job DescriptionAbout the RoleWe are seeking a highly skilled and experienced Director of Clinical Operations to join our team at Worldwide Clinical Trials. As a key member of our leadership team, you will be responsible for overseeing the clinical operations department, ensuring the successful execution of Phase I studies at...
