Director, Clinical Operations

Location
Foster City, CA, United States
Posted
Nov 01, 2020
Ref
198773142
Required Education
Bachelors Degree
Position Type
Full time
Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our programs are focused on cholestatic liver diseases in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSITION SUMMARY

The Director, Clinical Operations will lead and drive all aspects of clinical operations for the volixibat clinical program, including interaction with senior leadership, as well as clinical development, regulatory affairs and CMC functional groups. The Director, Clinical Operations will also oversee vendor management of the CRO(s) and other key study vendors.

JOB FUNCTIONS/RESPONSIBILITIES
  • Supports program lead with setting and timely executing the development strategies for the clinical program.
  • Responsible for the strategic and operational oversight, management, execution and delivery of the clinical studies for one or more clinical programs.
  • Oversight of clinical operations team for assigned clinical program(s) in the identification of potential challenges or risks with clinical study conduct and implementation of mitigation plans.
  • Responsible for development and execution of clinical site engagement and patient recruitment strategies for assigned clinical program(s).
  • Leads the Study Management Team (SMT) for assigned clinical program(s).
  • 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 request for proposals, leading bid defense meetings, 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 the clinical program/studies, and may co-lead operational governance meetings
  • 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 assigned clinical program(s).
  • 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 program(s) including preparing related operating plans and ensuring adherence to planned study budgets.
  • Supports Clinical Operations department head with strategic initiatives/implementation of those initiatives for process and operational improvements.
  • Oversees/co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections.
  • Supports Clinical Operations department head on SOP development.
  • May attend advisory board meetings and regulatory agency meetings related to strategy of program, indication, and studies.
  • Oversees resource planning for assigned program to support Clinical Operations department head in overall departmental resource management.
  • Supports Clinical Operations department head with interviewing, hiring, and training of new employees.
  • Plans, assigns, and directs work of clinical operations staff for assigned clinical program(s).
  • Line management responsibility for clinical operations staff (Jr. to Sr. staff levels). including mentoring and guidance.

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
  • Demonstrated 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.
  • Demonstrated ability to work in a fast paced environment with multiple competing tasks and demands, across time-zones.
  • Demonstrated 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.
  • High level of professionalism with internal and external stakeholders.
  • Demonstrated ability to remove barriers to success.
  • In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g. ICH/GCP).
  • Previous line management or direct management of team members.
  • Strong knowledge of applicable computer and project management software packages.

To apply, please send your resume to careers@mirumpharma.com