Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
The Director, Clinical Operations will lead and drive all aspects of clinical operations for one of our clinical programs, including interaction with regulatory affairs and CMC as well as vendor management of the CRO.
- 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 of mitigation plans.
- Leads the Study Management Team (SMT) for one or more development products.
- Represents the SMT in 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.
- May attend advisory board meetings and regulatory agency meetings related to strategy of program, indication, and studies.
- Oversees resource planning for one or more compounds.
- Interviews, hires, and trains new employees.
- Plans, assigns, and directs work of clinical operations staff for one or more products.
- Line management responsibility for clinical operations staff (Jr. to Sr. staff levels). including mentoring and guiding the clinical operations team.
- 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 attention to detail and the ability to establish priorities for team.
- Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones.
- Ability to work independently, take initiative, complete tasks to deadlines and support Clinical operations team in doing the same.
- Demonstrated ability to lead, motivate and mentor staff and teams.
- Excellent written and oral communication skills.
- Displays a high level of professionalism with internal and external stakeholders.
- Proven ability to remove barriers to success.
- Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
- Previous line management or direct management of team members.
- Strong knowledge of applicable computer and project management software packages.
- Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP).
- This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
Please submit your resume to firstname.lastname@example.org