Senior Director, Clinical Operations
Location: South San Francisco
Posted on: June 23, 2025
|
|
Job Description:
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. Strategically plan and execute clinical trials,
ensuring they are conducted within timelines, budget, and
regulatory and corporate quality standards. Actively lead and
participate in the development of critical study documents, such as
protocols, ICFs, study plans/manuals, investigator brochures, and
clinical study reports. Lead constructive interactions with
clinical sites to ensure that all trials and programs have clearly
defined plans, strategies, and milestones. Identify outsourcing
needs and oversee the selection, management, and performance of
CROs, vendors, and external consultants. Be accountable for
budgeting, forecasting, and overall management of clinical budgets.
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. Lead responses to
audits as required, including site, internal file and process, and
regulatory agency audits. 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). The Ideal
Candidate: 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. 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. The salary range for this position is $235,000
USD to $280,000 USD annually. This salary range is an estimate, and
the actual salary may vary based on the Company’s compensation
practices. This position is located in South San Francisco, CA,
with an expectation to be onsite Tuesday through Thursday. At this
time we are not considering remote applicants. Alumis Inc. is an
equal opportunity employer. Alumis compensation packages include
generous stock option grants for all employees as well as an annual
bonus program. Other benefits include: Health insurance premiums
paid at 90% for employee, 80% for dependents Free access to
Genentech Bus & Ferry Share program $100 monthly cell phone stipend
Unlimited PTO for Exempt employees Free onsite gym and a kitchen
stocked with yummy snacks and drinks! We are a hard-working,
collaborative team on a mission to transform patient’s lives and we
aspire to elevate , challenge and nurture one another along the
way.
Keywords: , San Bruno , Senior Director, Clinical Operations, Science, Research & Development , South San Francisco, California