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Clinical Project Management Associate Director


Boston, Massachusetts
  • Business Development/Operations
  • Project Management
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  • Research Salary

Job Details

The Clinical Program Lead (COPL): Early Phase Lead, is responsible for the planning, oversight, and execution of program-level deliverables to ensure corporate objectives are met. These deliverables include, but are not limited to, study level expertise in a variety developing and managing early development plans, program study timelines and budgets, working with cross-functional teams, and communicating and escalating status and issues to peers and senior management. This position reports to the Head of Program Operations Management in the Clinical Development Execution (CDE) group, which is in Global Medicines Development and Affairs (GMDA) and will have a strong affiliation with the Leadership Team of CDE.

The Associate Director, COPL: Early Phase is a is a specialist role representing CDE across multiple Program teams for internal coordination necessary for the conduct of all early phase clinical studies. These responsibilities generally include, but are not limited to:

  • Representing CDE as a Phase I specialist program member, responsible for the development and execution of the clinical development plans (CDPs) in conjunction with the individual Program teams.

o Contributes both as a strategic (eg key decision points and risk, study scenario planning) and operational perspectives (eg study timelines and financials) in all aspects of Phase I.

  • Accountability for operational delivery of all Phase I studies across programs, overseeing cross-functional alignment, budget, and timeline from protocol generation through to completion of the clinical study report.
  • Understanding all elements of Phase I clinical trial execution and regulatory reporting, ensuring studies are conducted within the parameters of GCP compliance and assists with remediation as necessary.
  • Key member of Phase I Joint Operating Committees and co-lead of Phase I center of excellence cross functional working group.
  • Identifying and interpreting risks, and implementing mitigation strategies/corrective actions to address them.
  • Developing precise, accurate, timely and succinct written and verbal communications to provide peers and management with status updates, and escalating risks as appropriate. Effectively influencing and ensuring seamless, two-way communications and information sharing to external stakeholders (eg KOLs and research sites) to ensure well-coordinated team dynamics




  • Bachelor’s Degree and at least 10 years global matrix drug development clinical research and operational strategy experience
  • Experience working in Phase I in a variety of different study types, vendors and geographies

Preferred Qualifications

  • Demonstration of project/program management skills including risk assessment, timeline and budget management and contingency planning.
  • Demonstration of effective team leadership in cross-functional matrix teams. Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
  • Must be fully self-motivated, able to identify and take appropriate initiatives to fulfil the requirements of the role, and possess the ability to maintain a high level of productivity with minimal supervision.
  • Ability to work in a highly time-sensitive environment and deliver unusually high throughput with acceptable quality when necessary.
  • Expertise in Microsoft Word, PowerPoint, and Excel is required.
  • Scientific education with graduate-level education in sciences or business
  • Experience in Microsoft Project and financial acumen
  • Ability to perform medical literature reviews, interpreting and presenting scientific/clinical trial data; understanding statistical analyses.
  • Ability to travel 15-20%
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