Vp, Clinical Operations

(San Diego, CA)

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

We are seeking a highly motivated, hands-on VP, Clinical Operations. This person will have hands-on leadership and management experience, including demonstrable expertise in the successful planning and execution of clinical development plans and studies within current and future indications. The role will also be active in planning and organizing project documentation and processes to support regulatory filings.

Responsibilities

• Oversee the overall execution of the assigned clinical program(s) with focus on quality, budget, and timelines, including making decisions or recommending operational strategies in support of achieving Phase II and Phase III clinical program objectives.
• Leads the strategy and tactics to successfully work with vendors, investigators, and cross functional departments to develop, implement and deliver clinical studies/programs supporting our Phase II and Phase III programs.
• Champions, promotes, and supports the development of high-quality, hard-working study teams to deliver outstanding clinical trials.
• Has broad experience selecting, managing, troubleshooting, and negotiating with (CROs) and supporting vendors.
• Leads strategies for patient recruitment and retention in clinical trials.
• Establishes performance, quality, business efficiency, and innovation metrics for the clinical teams and vendors in collaboration with Quality and Risk Management; seeks to improve quality across study programs and ensures quality processes are followed.
• Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs.
• Prepares and delivers training, both internally and externally, on new objectives or mandates from authorities, and on training associated with the clinical trials (Investigator Meetings, Re-training).
• Oversees and is accountable for program budgets, staffing, and timelines.

Qualifications

• Bachelor’s degree in the life sciences or related field. Advanced degree preferred.
• 12 years or more of experience in the Life Sciences industry and/or clinical research organization, including 9 or more years of clinical study management and 10 or more years of proven experience in leadership and people management roles.
• Practical experience in clinical trial design, operations, and management, with early and late-stage clinical trials experience in pulmonology, gastroenterology, or dermatology is highly desirable.
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
• Experience leading and handling complex global clinical development programs is required.
• Demonstrated track record of interpreting executive level research/scientific business requirements into operational strategies globally.
• Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions.

Skills and Abilities

• Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities; and ability to effectively give presentations at conferences, advisory meetings, and other public forums.
• A hands-on, entrepreneurial style with a sense of urgency, a bias toward action, comfort with calculated risk, and the ability to analyze situations rapidly and make prudent decisions.
• Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in a highly dynamic work environment and embrace uncertainty.
• Known to work with cross-functional collaboration and lead multiple assignments with timely and accurate output.
• Adept at crafting and presenting a clear vision among direct reports, efficiently aligning resources, and motivating teams to achieve goals.
• Demonstrated analytical abilities and proficient planning and negotiation skills.
• Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity.
• Travel, including international travel, approximately 25%

The expected base pay range for this position is $250,000 – $375,000 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.

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.

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