Director, Clinical Operations

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 Director, Clinical Operations will ensure that clinical strategies and study protocols are translated into operational plans for assigned studies. Works closely with Clinical Development and functions to ensure high quality deliverables. This role will be responsible for overseeing a programs or indications as assigned.

Responsibilities

• Implement successful trial conduct while ensuring the trial is conducted according to corporate timelines and budget.


• Demonstrated leadership in the planning, execution, and completion of clinical trials- on-time, on-budget and adhering to all regulatory and patient safety requirements.


• Oversees the completion of all study-related plans and systems according to timelines and standards.


• Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.


• Oversight of program budget, and vendor contracts.


• 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 support and strategy to integrate systems to support the assessment of eligibility and endpoints.


• Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready.


• Develop and drive aggressive recruitment strategies, developing slides and presenting as needed to cross functional teams and leadership.


• Interacts with and participates in strategy discussions with other functional areas and key stakeholders, including Clinical Development, CMC, early development, and clinical vendors (e.g., central laboratory, CROs), as needed, to provide a clinical operations perspective.


• Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors.


• Partner effectively with CROs, vendors, investigators, and key stakeholders.


• May have functional reporting responsibilities or indirect reports (e.g., study team members).


• Point of escalation for identified risks and mitigates with team as appropriate.


• Supports audit/inspection activities as needed.


• Maintain clinical trial registry entry/updates, as required.


• Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.

Experience and Qualifications

• Bachelor’s degree in a health or science-related field (e.g., RN).


• 8 or more years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget and progressive clinical trial management experience across the full cycle of drug development (Phase 1 through Phase 3).


• Experience in inflammatory and immunology diseases across multiple indications.


• Experience in building integrated systems to support study execution.


• Participation in an NDA inspection and/or HA inspection is a plus.


• Demonstrated leadership in the management and monitoring of CRO and investigative sites.


• Experience with patient recruitment, non-compliance, safety, document management, investigational product, accountability, and budget management.


• Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations.

Skills and Abilities

• Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards.


• Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization.


• Ability to effectively present information and respond to questions from all levels of the organization.


• Sense of urgency, flawless execution with intense focus on accuracy and accountability.


• Self-starter, highly motivated, assertive, driven and hands-on leader.


• Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment.


• Operate collaboratively with colleagues across functional areas in a science-driven environment.


• Ability to forge solid personal and professional relationships with key opinion leaders and investigators.


• Ability to work well under pressure and meet time sensitive deadlines.


• Ability to work across locations and time zones.


• Travel up to 25%.

The expected base pay range for this position is $175,000 - $220,000 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.

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Location: San Diego, CA, US

Posted Date: 11/24/2024