Associate Director, Clinical Operations

 

Title: Associate Director, Clinical Operations
Reports to: Director/Sr. Director, Clinical Operations
Department: Clinical Research and Development

miRagen Therapeutics, Inc. is a clinical stage biopharmaceutical company developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. Using our expertise in RNA-based therapeutics and systems biology we have created a diverse pipeline of RNA-targeted product candidates.

 

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 milestones
  • Develops and maintains effective working relationships with internal stakeholders and external partners
  • May travel up to 25-30% of the time

 

Qualifications

  • BA/BS degree in Health or Life Sciences required, advanced degree preferred
  • Prior experience in direct line management
  • Must have at least 8 years clinical operations management experience or demonstration of equivalent capability in an Associate Director level role

 

Required Skills and Abilities

  • Exceptional communication and interpersonal skills
  • Advanced proficiency in Microsoft Office, Microsoft Project
  • Reliable, self-motivated, team player
  • Detail oriented with excellent organizational skills
  • Ability to manage external vendors

Ability to effectively manage multiple tasks and competing priorities