Director, Clinical Operations--Infectious Disease

Location: Boston, Massachusetts, United States
Salary: US$160000 - US$200000 per annum + negotiable
Job Type: Permanent
Apply for this Job

Director of Clinical Operations--Infectious Disease

Position Responsibilities include:

  • Oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical programs.
  • Develop and implement clinical project plans in accordance with corporate and regulatory objectives
  • Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
  • Manage clinical trial resources and reforecasting projections, including hiring plans and external budgets
  • Maintain an inspection readiness state throughout the lifecycle of the trial
  • Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
  • Contribute to global clinical / regulatory submissions
  • Communicate study updates to senior leadership and in open forum presentations
  • Lead development of departmental SOP's and ensure compliance
  • May require travel

Candidate Requirements:

  • Bachelor's in a scientific discipline; advanced degree preferred
  • Minimum 7 years of experience in a biotech/pharmaceutical, principally in oncology drug development and clinical operations
  • Comfortable in a fast-paced small biotech environment with the ability to adapt to change
  • Experience over-seeing CRO partners as the point of contact and lead project manager
  • Cell therapy experience a bonus
  • Highly organized, outcome oriented, self-motivated performance
  • Hands-on working style with ability to play as individual contributor as needed
  • In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, strong conflict management and negotiation skills
  • Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice

Sthree US is acting as an Employment Agency in relation to this vacancy.

Apply for this Job