Director Study Management - Pharma - MA

Boston Permanent USD150,000 - USD225,000
  • Dig deep into the biology of complex disease and uncover breakthroughs
  • Push the boundaries of science and unleash your entrepreneurial spirit

About Our Client

Our client is a global biopharmceutical company that focuses on the discovery, development, and commercialization of prescription medicines. They focus on three main therapy areas - Oncology, Cardiovascular & Metabolic Disease (CVMD) and Respiratory. This publicly traded company has over 50,000 employees and constantly pushing the boundaries of science.

Job Description

  • Functional representation during development of process changes and improvements: providing functional inputs and leadership throughout the cycle of business process and procedural document changes
  • Approving changes: Reviewing and managing the functional approval of all changes to clinical business processes and mandatory procedural documents
  • Process KPIs & measurement: Developing, designing and applying insights from process metrics to inform process and business improvement activities in their function
  • Change agent to support the effective uptake and adoption of new and changed processes including directing comms and engagement effort in the functions to the right user communities
  • First line of support for process users: supporting functional process users by answering questions arising from the user community
  • Being the functional subject matter expert and maintaining industry best practice awareness and up to date knowledge of international standards, regulations and guidelines relevant for SM activities
  • Being the first point of contact for the SM process users regarding any questions, queries (including OS ticket), issues or risks that arise at the process functional level and provide business knowledge and guidance to the function
  • Escalate to the BPMO any issues or risks that cannot be resolved at the functional level
  • Responsible for lifecycle management of non-mandatory procedural documents guidelines, forms, non-mandatory templates and training materials and for ensuring compliance with applicable industry regulations and Global and Local Policies
  • Inspection accountability for SM non-mandatory procedural documents and availability for inspection Q&A related to SM functional questions
  • Being the champion of the process and any relevant SOPs and working practices at the functional level
  • Responsible for the effective and timely communication of information, and for the development and delivery of high- quality training materials for the allocated area.
  • You'll be jointly responsible with the BPMO for the successful implementation of a process-centric culture to improve quality & efficiency and to support delivery of changes and improvements to the business processes and procedures which underpin clinical trials.
  • You'll also liaise and cooperate closely with BPMO in Process Quality and Learning (PQL) and systems owners within Global Clinical Solutions (GCS) to ensure SM's user requirements are met in all AZ global systems and processes, and to support effective implementation in SM

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelor of Science in an appropriate discipline or equivalent experience
  • Significant operational experience in Drug Development within a pharmaceutical or clinical background
  • High level of business process, technology and Clinical Study information knowledge
  • Demonstrated project management skills and proven skills to deliver to time and quality
  • Experience in working successfully and collaboratively with external partners
  • Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.
  • Previous experience in Process Owner's roles
  • Previous experience in attending regulatory inspections
  • Expert reputation within the business and industry
  • Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
  • Experience in the development and management of Business Process to deliver business performance.

What's on Offer

  • Extremely competitive compensation package
  • Amazing health and wellness benefits
  • Stock options
  • Flexible work schedule (hybrid model)
  • Growth opportunity
  • Inclusive culture that champions diversity and collaboration
Connor Colombo
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Connor Colombo
Job Reference