Director of Clinical Operations

Job description

We are searching for a talented Clinical Operations expert who is willing to build the Clinical Operations function at Sound Pharmaceuticals from the ground up. The Director of Clinical Operations will be accountable for the operational strategic planning, oversight and delivery for multiple clinical programs. The Director is accountable for the line management of Clinical Operations staff, including development, coaching, training, talent planning and performance management. The Director will lead and/or sponsor Clinical Operations organizational initiatives.   

The core duties and responsibilities of the Director include, but are not limited to:

Responsibilities:

  • Lead the operational strategy and functional management for one or more clinical trial programs, in accordance with the Clinical Development Plans and program plans
  • Accountable for the development and implementation of clinical development program strategies; planning horizon is typically 12-24 months
  • Oversee the development of study project plans, including timelines, metrics, budgets, and resources
  • Develop and present operational plans to management
  • Oversee the Clinical Operations team to ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budgets
  • Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions
  • Represent Clinical Operations on the project teams, such as the Development Sub-Team and Program Core Team
  • Identify program risks, develop and implement mitigation strategies for assigned programs
  • Manage and mentor Clinical Operations personnel
  • Ensure employees and contractors are appropriately trained to comply with company and regulatory standards
  • Develop and implement corporate and department organizational goals
  • Lead working groups or initiatives
  • Make recommendations to management on matters related to human resources, budget and department operations
  • Recognized as an effective leader in Clinical Operations
  • May be responsible for the following activities:
  • Participate in and/or facilitate CRO/vendor selection process for outsourced activities
  • Oversee CRO interactions, including sponsor oversight of operational functional activities, such as study management, training and monitoring

Desired Skills and Experience

  • Advanced degree in a related discipline preferred, BS is required
  • 10+ years of progressively more challenging experience in clinical and drug development, including 5+ years leading clinical operations having direct oversight and management of employees
  • Prior management experience at the Associate Director level or equivalent
  • Demonstrated ability to lead development programs and study teams
  • Experience with international trials a plus
  • Rare disease clinical trial experience desired
  • Ability to provide scientific and clinical expertise to a clinical development program
  • Working knowledgeable of FDA regulations and ICH GCP guidelines is required
  • Familiar with advanced concepts of clinical research (including complex study designs) and able to work effectively in a team/matrix environment
  • Strong strategic planning and decision-making skills
  • Ability to deal with time demands, incomplete information or unexpected events
  • Must have the ability to build and maintain positive relationships with management, peers, and direct report

Interested candidates are encouraged to apply by sending a resume and a cover letter to info@SoundPharma.com for consideration. Sound Pharmaceuticals, Inc. is an equal opportunity employer and supports diversity in the workplace.