Senior Manager, Clinical Operations – San Diego, CA
Company: Mirador Therapeutics, Inc.
Location: San Diego
Posted on: December 31, 2025
|
|
|
Job Description:
Mirador is a next-generation precision medicine company focused
on immunology and inflammation. The company’s Mirador360 TM
precision development engine leverages the latest advances in human
genetics and cutting-edge data science to rapidly advance new
precision medicines for patients living with chronic
immune-mediated inflammatory and fibrotic diseases. Launched in
2024, Mirador has raised over $400 million from leading life
sciences investors and is based in San Diego, CA. Summary The
Senior Manager, Clinical Operations will ensure that study
protocols are executed according to the operational plan for
assigned studies. Works closely with Clinical Development within
the Clinical Operations Program and with all functions involved to
ensure high quality deliverables. This role may be responsible for
Phase 1 studies, or Phase 2/3 global studies. Responsibilities
Supports the clinical trial program lead in the execution of a
protocol or program. Participates in the review of the protocol,
provides an operational feasibility perspective and confirms
clarity of procedures. Development of or oversight of the
development and approval of the informed consent. Drives the review
and completion of all study-related plans and systems according to
timelines and standards. Ensures the Clinical Operations Oversight
Plan is executed per the plan requirements. Oversight of monitoring
activities, including review of monitoring reports and
co-monitoring as needed. Contributes to ongoing department
infrastructure development efforts such as SOP development,
implementation and/or innovation of new processes for assigned
studies within the department. Oversees study budget, investigator
and vendor contracts, budgets, and payments; reviews accruals on a
regular basis. Proactively identifies risks and resolves
operational issues/processes to ensure achievement of study
milestones, data quality and data integrity; escalates
study-related issues, risks and mitigation plans to management in a
timely manner. Provides oversight for the setup, maintenance, and
close-out of the Trial Master File and ensures it is complete and
audit ready. Develops and drives aggressive recruitment strategies,
and ensures CRO is executing the agreed upon strategy. Participates
in the selection and oversight of Contract Research Organizations
(CROs) and vendors. May have functional reporting responsibilities
or indirect reports (e.g., study team members). Supports
audit/inspection activities as needed. Provides mentorship/guidance
to less experienced team members or cross-functional colleagues on
study processes/study requirements. Remains current on
pharmaceutical regulations, guidelines and practices and
therapeutic area knowledge and ensures consistent best practice
across all activities. Maintains knowledge of ICH-GCP, external
regulations and procedures. Experience and Qualifications
Bachelor’s degree in a health-related field (e.g., RN) with 6 or
more years of clinical trial management experience, including
CRO/vendor management (domestic and international and monitoring of
budget). Skills and Abilities Collaboration, teamwork, and passion
for excellence in clinical operations. Ability to be flexible,
think “outside the box” and identify new solutions to execution of
studies. Demonstrated leadership in the management and monitoring
of CRO and investigative sites. Advanced experience with patient
recruitment, non-compliance, safety, document management,
investigational product, IP accountability, and budget management.
Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority
drug research & development regulations. Motivated to work in a
fast-paced, high accountability environment. Demonstrated agility
to learn, and prioritize multiple responsibilities independently,
remove barriers and drive projects to completion. Strong oral and
written scientific communications skills. Good presentation skills
for diverse audiences (investigator meetings, site personnel, and
internal project teams). Ability to strike a balance between
independent work and team interaction, be a team player in a
cross-functional team. Well-developed interpersonal skills, with
experience in interacting with and influencing people, building
strong positive relationships. Proficiency in Microsoft Office and
other productivity tools with an aptitude to learn new software and
systems; ability to work with large databases. Requires strong
understanding of FDA, EU, ICH guidelines. Ability to travel up to
10%. The expected base pay range for this position is $125,000 –
$150,000 plus bonus, equity, and comprehensive benefits. The base
pay range reflects the target range for this position, but
individual pay will be determined by additional factors such as
job-related skills, experience and relevant education or training.
This range may be modified in the future. LI-onsite Working at
Mirador Therapeutics | Great Place To Work® All qualified
applicants are considered for employment without regard to race,
color, religion, age, sex, sexual orientation, gender identity,
national origin, disability, veteran status or other protected
class. Read our Job Applicant Privacy Policy
Keywords: Mirador Therapeutics, Inc., Huntington Beach , Senior Manager, Clinical Operations – San Diego, CA, Science, Research & Development , San Diego, California