Senior Vice President, Clinical Operations

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team:

Position Summary

The SVP of Clinical Operations will be responsible for developing and implementing strategies to successfully execute Mirum’ current and future clinical trials. This leadership position requires a self-directed, dynamic, inspirational leader with a passion for advancing treatment options and outcomes in rare diseases. The SVP must possess collaboration and consensus building skills to ensure the clinical stage projects achieve the objectives within budget and timelines with a strong focus on operational efficiency and execution. The ideal candidate will have strong clinical, leadership and communication skills. In addition, the SVP will be a hands-on leader willing to roll-up their sleeves to ensure the highest quality of work output.

Job Functions/Responsibilities

• Mentors and develops development operations personnel
• Serves as a key member of the product team and leadership team, and contributes to the development of product and business strategies to maximize the value of the company’s portfolio
• Proactively supports the management of CRO partnerships and serves on governance committees as part of oversight of CROs and vendors for the efficient execution of our current clinical program and proactive identification and rapid resolution of any performance issues, acting as a point of contact for executive level escalation
• Leads initiatives in conjunction with Clinical Operations leadership to build clinical operations department infrastructure and implements best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs
• Provides strategic leadership during health authority inspections; ensure compliance with SOPs, ICH-GCP guidelines, regulatory authority regulations, and patient safety standards
• Provides operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.
• Flexes easily between taking a high level, strategic view and delving into details as needed in partnership with the clinical operations team
• Able to travel internationally to meet with International team members as needed to build collaboration across the development operations
• Participates in the review, planning and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and identifying operational problems that may impede the study.
• Drives global clinical operations teams through required and complex cross-functional decision making and internal processes to deliver on clinical trial execution
• Acts as internal champion, ensuring that clinical programs are properly resourced, managed and executed in accordance with agreed timelines, budgets and department goals in support of corporate objectives
• Drives tight financial management of clinical operations vendors including negotiation of performance driven contracts and budgets/change orders, completion of precise and timely accruals by clinical operations team, and accurate forecasting for company operating plans
• Works collaboratively in a cross functional team environment with functional leaders responsible for Program Management, Clinical Development, Biometrics, Medical Writing, Supply Chain, Medical Affairs, Regulatory Affairs, and Legal/Finance & Accounting
• Participates in diligence activities for potential new asset acquisition and supports integration of new assets/development teams into the organization
• Offers oversight on the progress of clinical trials and ensures adherence to the protocol, timelines, and budget. This includes the identification, selection, contracting and management of vendors and reviewing site recruitment, initiation and patient enrollment progress
• Contributes to developing and providing input to protocols, annual safety reports, clinical study reports, publications/presentations and regulatory submissions.
• Oversees a global clinical operations team responsible for successful delivery and execution of clinical trials across the company portfolio

Qualifications

Education/Experience:

• Experience in complex studies and regulatory inspections,
• Leadership of a global team for a minimum of 10 years
• Experince in the conduct of rare disease clinical trials is strongly preferred
• Bachelors Degree or higher in scientific/healthcare/business field
• Progressive experience (15+ years) in executing international, registrational enabling clinical trials including in a pharmaceutical/biotech setting where clinical trials were outsourced to a CRO

Knowledge, Skills And Abilities

• Effective, proactive, and open communications, to achieve transparency and clarity of clinical trial goals with team members, executive management, key stakeholders and broader organization
• Leads by example, role model for other leaders, demonstrates a firm commitment to company values and culture
• Strategic and proactive thinking, strong scientific and analytical skills, decisiveness.
• Thorough understanding of drug development from IND to NDA
• Proven success in leading and coordinating cross-functional clinical operations teams.
• Comfortable multi-tasking in a fast-paced global company environment and able to adjust based upon changing priorities and various time zones
• Proven ability to build strong relationships with CROs/vendors and to manage CROs and vendors throughout entire clinical operations life cycle
• Ability to anticipate future trends in clinical trial execution, is highly collaborative, and has a broad and deep knowledge and perspective of clinical operations and drug development
• Experience developing and coaching direct reports and assessing talent and areas of opportunity
• Experience in developing and coaching clinical operations team in end-to-end management of clinical trial conduct, and in-depth knowledge of the pharmaceutical industry, clinical drug development, and regulatory strategies

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.