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Director/Senior Director, Clinical Operations

Reference Number: 2868
Location: MA

Our client is a leading biotechnology company.  They have asked us to assist them in their search for a Director/Senior Director, Clinical Operations.

The Director/Senior Director, Clinical Operations is responsible for the clinical operation strategy of projects medical affairs/post-marketing stages in the US.  As a core project team member, the incumbent is the main partner for the US Medical Affairs unit, providing CSO expertise to support project team decisions and the best operational strategy for the successful conduct of the project.  He/she will direct, supervise, and manage full Clinical Science & Operations (CSO) platform activities to the partner’s satisfaction and company success and is accountable for ensuring quality deliverables on time and within budget.  This position is accountable for ensuring the deliverables via effective program, project management and leadership skills in a manner that will optimize, integrate, and utilize CSO resources and competencies.  This position contributes to the definition of the outsourcing strategy for the project.  He/she will ensure reliable performance and productivity by leading and coordinating all platform expertise and services for the allocated project(s) / program(s) and is accountable to both the customer and platform for project deliverables, including the timelines, quality and budget.  This position is also the CSO’s main interface with other platforms, Unit/Division for the project and enabling functions.  He/she will provide consolidated recommendations to the project teams and will ensure communication to relevant stakeholders.

Major tasks and responsibilities will include:

  • Represents CSO and is accountable for CSO activities within the project team.
  • Brings CSO expertise and provides clinical operational strategy in line with the project objectives with input from all applicable functions within the CSO.
  • Brings the optimal clinical operations solutions and scopes of work that creates the most value for the project, partner and the platform.
  • Based on performance, builds a strong relationship with the partner in order to develop and maintain credible CSO platform services.
  • Ensures appropriate communications channels are maintained and reporting schedules adhere to key relationship management for the program.
  • Responsible for routine reporting of the project’s status to partner.
  • Develops and negotiates study/program budgets, timelines and project expectations in order to establish clear accountabilities.
  • Responsible for financial oversight of the project/program and leads renegotiations when required.
  • Responsible for assessing impact of CSO activities on the project strategy; identifies bottleneck and proposes solutions.
  • Accountable for ensuring the study/program execution of the clinical plan according to project requirements & defined project objectives.
  • Actively represents the project within CSO and ensures proper and regular communication and alert CSO management as needed.
  • Responsible for initiating the discussion related to the alignment among the Project on country and site selection between the Medical Affairs, CSO, the Unit/Division or other customer.
  • Develops and implements continuous improvement for assigned projects to ensure the quality of the deliverables.
  • Communicates appropriately the risks identified.  Anticipates project risks and develops and implements risk management plans to minimize negative impact in fulfilling project deliverables.
  • Oversight and accountable for project performance to ensure it meets the project’s and CSO’s expectations as far as timelines, quality, and budget.  Makes adjustments to the project and/or team as required to meet project’s needs / requirements.
  • Leads development of phase transition plans for project.
  • Ensures communication and tracking of project management information within the CSO.
  • Seeks cross-project fertilization and enrolment of experts in the fields.
  • Leads the multi-disciplinary CSO or clinical sub-project team in order to ensure high performance in deliverables.
  • Transmits clear project requirements to the CSO functions.
  • Sets team goals, gains alignment, and provides performance reviews for the team performance.
  • In conjunction with the CSO function management, builds study teams that are adapted to meet the project’s needs/requirements.
  • Manages CSO activity status across studies (operational, budget & resource) and critical issues.
  • Fosters alignment and commitment to high quality deliverables of CSO team members.
  • Contributes to the definition of the outsourcing strategy for the project.  Leads the discussions on the choice of vendors for outsourced programs by providing input into vendors used for specific activities and is accountable for deliverables for full-package outsourcing.
  • Contributes to CSO business expansion and develop the CSO catalogue for services.
  • Identifies opportunities for improving organizational processes to continue to drive organizational and operational excellence.

We seek candidates with the following qualifications:

  • BS/BA in a scientific background required.  PharmD, MD, or PhD preferred.
  • 10+ years of clinical research/project management experience and ability to work in complex and matrix environment.
  • Previous experience with Medical Affairs preferred.
  • Experience and understanding of current Pharmaceutical environment.
  • Experience leading international teams.


Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2868. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.