Associate Director, Clinical Operations

Employer
miRagen Therapeutics
Location
80301, Boulder
Posted
Oct 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Associate Director, Clinical Operations, is responsible for leading the execution of clinical 
programs to required quality standards and miRagen Standard Operating Procedures, on schedule and 
on budget, and providing strategic leadership for the Clinical Research and Development function. 
Primary responsibilities include:

•    Responsible for leading a program or a small therapy area for Clinical Operations to support 
     achievement of assigned business goals
•    Leads the development of program operational strategy in collaboration with key stakeholders
•    Oversees the delivery of large studies or programs critical to a product’s clinical development 
     to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and 
     global regulations and ICH/GCP guidelines
•    Responsible for external vendor selection processes, vendor budget and contract negotiations, and 
     vendor management for assigned studies or programs, and assists in the development of RFPs and 
     vendor oversight plans
•    Manages overall clinical trial budget for all assigned programs or studies
•    Implements and mitigates resourcing strategies to deliver best efficiency and value, including 
     strategic oversight of Clinical Research Organizations and/or contracted resources, such as CRAs
•    Able to perform Clinical Trial Manager (CTM) tasks and duties such as the development of 
     timelines and budgets for assigned studies/programs; the delivery of studies/program to internal 
     quality standards and agreed timelines; able to plan, negotiate, and manage site budgets; 
     facilitate site contracting process; develop and implement robust contingency and issue management 
     plans to solve complex issues that impact study or program milestones; oversight
     of project training
•    May be the line manager for CTM levels and below, including providing leadership, guidance and 
     direction to assigned staff
•    Leads quality oversight initiatives
•    Leads DMC oversight and activities
•    Supports the use of and is an effective end-user of Clinical Systems (e.g. EDC, CTMS, eTMF, etc.)
•    May lead therapy area and/or Clinical Operations meetings
•    Directs exploratory feasibility exercises at program or indication level
•    Leads the development of critical process standards, policies and SOPs
•    Leads the development of Clinical Operations documents and templates
•    Implements performance standards and is responsible for developing performance metric reports 
    across assigned programs or studies
•   Proactively serves on Clinical Operations Leadership Team
    Interacts with senior management to report clinical developments and study or program milestonesI nteracts      with senior management to report clinical developments and study or program
    milestones
•   Develops and maintains effective working relationships with internal stakeholders and external 
    partners
•   May travel up to 25-30% of the time