Senior Director, Clinical Operations

6 days ago

South San Francisco, United States Alumis Full time
Job 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 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.

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