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Director of Clinical Operations

Reference Number: 2831
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for a Director of Clinical Operations.

The Director of Clinical Operations leads the US Clinical Operations Team comprised of 14 staff members.  As this is a regional leadership role, the qualified candidate will participate as a member of the clinical development leadership team, partnering with team colleagues, contributing to the overall strategic direction and vision of the clinical development function.  The incumbent will be responsible for building and maintaining strategic relationships internally and externally; thereby requiring exceptional vendor management, communication and negotiation skills.  The ability to effectively partner with internal and external customers, other functional areas within the organization and engage direct reports is of paramount importance.

Operationally, the qualified candidate will focus on the planning, coordination, management, and execution of all clinical study-related activities and the ongoing support and development of clinical operations staff members; and must be adept at assessing complexity of work and delegating to staff members with commensurate experience.  As Director of the US Regional group, this person must successfully reinforce and provide ongoing development to a constructive team culture that promotes excellent service to customers and positive communication.

Major tasks and responsibilities will include:

  • Provides technical/content expertise to lead teams and complex studies within the Clinical Operations group.
  • Directs the adherence to ICH/GCP guidelines, local regulatory requirements, and SOPs/SWPs.
  • Proactively assesses risks and develops and implements creative solutions.
  • Comprehensively assesses options to address study issues.
  • Supports the activities of CDP development from a portfolio perspective and reviews quality of data from studies prior to submission.
  • Aligns business and clinical operations objectives across multiple CROs, project teams, and departments.
  • Supports the execution of clinical operations strategies and implementation of new processes and systems.
  • Influences work/study processes spanning multiple departments and geographic boundaries across the company.
  • Facilitates across teams to identify clinical operations issues and proposes solutions.
  • Manages new tools and resources (tools, systems, vendors, etc.) while minimizing their costs to the organization.
  • Sets key deadlines and project milestones for projects within function.
  • Manages contractors and ensures contractors, consultants, and vendors complete assigned work according to agreed timelines.
  • Makes appropriate budgetary allocations to targeted opportunities.
  • Evaluates appropriateness of requests for increased budgets.
  • Directs the use of financial standards across work teams for consistent level of compliance.
  • Reviews 3rd party (contractors, consultants, and vendors) work product and deliverables to approve payment of invoices and resolve discrepancies.
  • Leads by example to encourage others to prioritize personal and professional development.
  • Acts as a coach and mentor to staff members across units.
  • Participates in recruitment, selection, performance, succession, and transition activities.
  • Identifies team training needs and recommends solutions.
  • Manages individual contributors and/or matrixed team members and manages people managers both locally and remotely.
  • Complies with all applicable laws/regulations of each country in which our client does business.

We seek candidates with the following qualifications:

  • BS/MS in relevant field.
  • A minimum of 10 years of clinical operations experience, including 4 years of management experience is required.
  • Must be able to substantiate successful experience across all phases of clinical trials (I - III).
  • Mega trial experience is highly desirable but not required.
  • Proven leadership, communication, and negotiation skills are required.

 

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 2831. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.