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Senior Director of Clinical Operations

Reference Number: 3005
Location: Remote

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for a Senior Director of Clinical Operations.

The Senior Director of Clinical Operations is responsible for overseeing and executing the clinical operations of large multi-center global clinical trials. This role provides leadership to the US and Global Clinical Operations organization by defining and driving global organizational strategies and ensuring strategic operational planning, optimal trial allocation, as well as high quality and compliant execution of clinical trials around the globe within agreed clinical program timelines budget.

This position also provides strategic and technical guidance to Clinical Development, CMC, Regulatory, and Quality Assurance. This person will ensure prioritization of programs and schedules, in accordance with overall corporate and Clinical Development objectives, goals and timelines. The incumbent will also participate in the development, planning, and execution of activities supportive of Phase III clinical studies.

Major tasks and responsibilities will include:

  • Works in a collaborative manner with Clinical Development, Project Management, Regulatory and Quality Assurance colleagues in support of clinical priorities and milestones. Has the ability to communicate information effectively within and between functional groups. Contributes and supports Global Clinical Development’s overall strategic plan.
  • Proactively identifies, mitigates and manages risk around global clinical operations issues.
  • Effectively manages the Clinical Operation Team members and consultants, and serves as the primary liaison in interactions with Contract Research Organizations (CROs) and vendors to achieve company goals.
  • Accurately estimates resources (budget, colleagues, and additional support staff) required for implementing clinical studies. Negotiates vendor contracts and budgets for all studies.
  • Oversees the preparation, review and revisions of Clinical Operation SOPs in connection with Quality Assurance leadership to assure consistent compliance with GCP practices and regulations while ensuring inspection readiness.
  • Oversees the relationship and progress of vendor CRO activities and ensures adherence to study protocols, SOPs, regulatory and internal operating procedures. This includes reviewing site activation, patient recruitment and patient enrollment progress including reviewing and acting on trending reports.
  • Responsible for the budget and resource planning. Develops and tracks Clinical Operations budget projections against actual spending and enrollment projections.
  • Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents.
  • Participates in the training and education of internal staff and external vendors, sites and investigators on study protocols. Participates in data-driven Quality Monitoring activities and the analysis of clinical data.
  • Organizes and manages investigator meetings.

We seek candidates with the following qualifications:

  • BS or MS.
  • 20 years of relevant clinical experience in the clinical trial setting.
  • Thorough understanding of the drug development process, clinical operations, regulatory process and considerations, and manufacturing.
  • Solid track record of clinical operations leadership and success in pharma/biotech organizations.
  • Previous clinical operations experience in a leadership role in large Phase III global clinical trials is required.
  • Lipid Disorders and Cardiovascular Outcomes trials experience preferred.
  • Extensive experience with compliance issues and strong understanding of FDA regulations; EU Clinical Trials Directive, GCP and/ SOPs in pharmaceutical, or biotech environment is a requirement.
  • Demonstrated abilities in decision making, leadership, and affecting change by a collaborative approach.
  • Experience in developing site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supply management.
  • Exceptional communication skills, both written and verbal.
  • Excellent interpersonal and conflict management skills.
  • Excellent organizational and project management skills.

 

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 3005. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.