Director, Clinical Operations

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. 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.

POSITION SUMMARY 

The Director, Clinical Operations is responsible for providing leadership to assigned clinical program(s) and for ensuring studies within a program are being managed in accordance with the Mirum’s overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a clinical program comply with the company’s procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director, Clinical Operations is also responsible for the development and implementation of clinical best practices for effective clinical study execution in accordance with regulations and from time to time may lead strategic and continuous improvement initiatives in clinical project execution and project management.

JOB FUNCTIONS/RESPONSIBILITIES 

• Provides leadership in the development of the clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program Lead.
• Collaborates with the SVP, Clinical Operations, to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
• Provides leadership to Clinical Projects to ensure trial/study teams, are managed in alignment with clinical program and Mirum goals.
• Provides Clinical Program updates, including trial status/metrics, budget, accomplishments and risks to SVP, Clinical Operations, Program Team Leads, Program Managers, Senior Management and other relevant stakeholders.
• Responsible for the strategic and operational oversight, management, execution and delivery of the clinical studies for one or more development products.
• Oversight of clinical operations team in the identification of potential challenges or risks with clinical study conduct and implementation mitigation plans.
• Represents the Clinical Operations at the Product Team (PT), to discuss urgent operational questions and to provide strategic operational input to the PT.
• Resolves and/or escalates issues raised by the clinical operations team or the SMT.
• Takes a lead role in vendor selection, including critical review of contracts and negotiation of work orders.
• Oversees CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of program/studies.
• Acts as the main escalation point of contact for strategic CRO partner(s) for the assigned program and for the key stakeholders in clinical operations.
• Ensures consistency between studies for one or more products.
• Provides input and clinical operations perspective on clinical trial design.
• Authors, provides input and/or oversees program level and study level documents to support clinical studies and regulatory submissions.
• Oversees financial aspects of assigned clinical study(ies) including preparing departmental level operating plans and ensuring adherence to planned study budgets.
• Provides direction for strategic initiatives/oversees implementation of those initiatives for process and operational improvements.
• Oversees/co-leads inspection readiness activities and acts as subject matter expert during regulatory inspections.
• Works closely with Quality Assurance on SOP development.

QUALIFICATIONS

Education/Experience:

• Advanced Degree in Scientific/healthcare field preferred.
• Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry (Biotech/small pharma experience preferred).
• Global clinical trial research experience.
• Experience leading cross functional teams.
• Experience in rare disease and/or liver disease is preferred.

Knowledge, Skills and Abilities:

• Demonstrated ability to present complex information to management, vendors and external audiences.
• Demonstrated ability to create and manage one or more program budgets including communication of overspend/underspend
• Ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
• Strong