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Associate Director, Clinical Trial Management
at Vertex
Boston, MA

Associate Director, Clinical Trial Management
at Vertex
Boston, MA

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Description

Job Description:

The Associate Director is an experienced and energetic individual with significant clinical drug development knowledge who helps build a high performing global team in the fast-paced and expanding Clinical Development Execution group with Global Medicines and Development Affairs. Reporting to the Executive Director/Head of Study Management, this position is responsible for implementing the strategic plans for Clinical Operations and overseeing Clinical Operations staff in the conduct of Phase I-IV clinical trials across multiple therapeutic areas in accordance with GCP and ICH regulations.

KEY RESPONSIBILITIES:
  • Directly manages junior Clinical Operations staff (Clinical Trial Associates, Clinical Trial Coordinators) with responsibility for staff training, performance management, setting individual employee goals and career growth opportunities for staff. May also manage FSP and contract staff, who may be remote to Vertex's offices.
  • Oversees CTA/CTC recruitment and resourcing, ensuring proper timing and allocation of resources to projects to achieve study timelines and deliverables.
  • Contributes to development of strategic plans for Clinical Operations and helps to translate strategic decisions into actionable operational plans.
  • Contributes to development of departmental goals and objectives to achieve corporate goals.
  • Partners with other functional areas within CDE, with other functional departments across Vertex and with CROs/vendors to ensure clinical trials are executed on time, within budget and with quality.
  • Defines and monitors key performance indicators and departmental metrics for Clinical Operations and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).
  • Contributes to oversight of vendors, including issue remediation and governance.
  • Participates in departmental and cross-functional process improvement initiatives, as required.

Qualification:

  • Bachelor of Science degree in a life sciences discipline, advanced degree preferred
  • At least 10 years of relevant work experience in the biopharmaceutical industry, with experience executing clinical trials globally across all phases of development
  • Excellent understanding of GCP, CFR and ICH guidelines
  • Prior experience with line management is ideal
  • Proven track record of successfully overseeing staff to deliver clinical trials on time, on budget and with quality while ensuring inspection readiness
  • Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team and to effectively manage external vendors/CROs
  • Excellent verbal and written communication and presentation skills
  • Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a mid-sized company environment

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