Associate Director, Clinical Supply Operations

  • Location:Cambridge,MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

RESPONSIBILITIES:

  • Leads Clinical Supply Operations function with authority to make key decisions relating to overall clinical supply strategy.
  • Develops and maintains long term inventory/forecast plans for clinical supply including drug product and internally produced clinical reagents considering overall demands, expiries, process yields, cycle times and demand.
  • Manages direct outsourcing of labeling, packaging and on-time distribution of drug supply to global sites.
  • Communicates and prioritizes and/or escalates clinical supply issues through the established internal and external pathways.
  • Leads Interactive Response Technology (IRT) system(s) vendor relationship including creation and oversight of IRT systems including managing development aspects such as system specifications, user acceptance testing and actively generating/managing IRT standards.
  • Ensure the required study-specific documentation in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
  • Maintains Clinical Supply Operations budget on an overall program level within approved limits, raising budgetary risks proactively, and identifies/generates/implements cost saving solutions.
  • Leads departmental systems development (Forms/SOPs/Inventory Management Systems).
  • Leads cross-functional projects/process improvement initiatives to ensure program level clinical supply activities are executed within specified time, quality and cost parameters.
  • Establishes metrics to define clinical supply operations performance and provide recommendations to optimize operations and build the function within Surface.
  • Project management expertise by demonstrating a high level of knowledge of supply methodologies, organizational, project management and leadership capabilities as well as increased strategic insight, decisiveness and strong judgment.
  • Leads cross-functional integration to ensure quality program and project execution.
  • Establishes key contractual and business relationships with new vendors as needed and contributes to success of ongoing vendor relationships including assessments and management through requesting proposals, negotiating major contracts and monitoring costs, schedules, and performance.
  • Identifies opportunities and lead initiatives to streamline processes and enhance productivity, efficiency and quality of outputs for Supply Operations.

 

EDUCATION AND EXPERIENCE: 

  • Senior level industry professional with 12+ years combined experience in specific area of expertise (e.g. packaging, logistics) or related field, including 5+ years of direct supervisory experience.
  • Bachelor’s degree required.  Advanced degree preferred.
  • Flexibility/adaptability to work in a fast-paced and dynamic environment.
  • Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment.
  • Excellent interpersonal, influencing and negotiation skills.
  • Proven problem solving and decision-making skills.
  • Excellent planning and project management skills.
  • Extensive knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GXPs governing the manufacture of pharmaceutical drug and conduct of routine clinical trials.
  • Successful track record with metrics, project delivery, collaboration and relationship management.
  • Experience managing/overseeing vendors/external partnerships and relations.